In case you missed it: Here are the top 5 posts this month

FDA approves a bedside test for assessing the risk of spontaneous preterm birth

QIAGEN won FDA approval for marketing its Novel PartoSure® point of care test for estimating the risk of spontaneous preterm birth in patients who present with symptoms of preterm labor. PartoSure represents a breakthrough in research and development of diagnostic tests for preterm birth.

Predicting preterm birth is a diagnostic challenge and nearly 85% of patients admitted to the hospital for threatened preterm labor (PTL) do not deliver within the next 7 days, resulting in unnecessary interventions.

https://obgynupdated.blogspot.com/2018/04/fda-approves-bedside-test-for-assessing.html

Medical management of adenomyosis: current and future therapies

The current issue of Journal of Fertility and Sterility has focused exclusively on etiology, pathophysiology, and medical and surgical treatment of adenomyosis. Adenomyosis has long been the source of controversy and its only with the recent advent of Transvaginal sonography (TVS) and MRI that its etiology and pathophysiology been better understood.

Adenomyosis is a uterine pathology in which the endometrial glands and stroma invaginate within the uterine myometrium. This ectopic endometrium induces hypertrophy and hyperplasia of the myometrium resulting in the typical ‘globular” enlargement of the uterus.

https://obgynupdated.blogspot.com/2018/04/medical-management-of-adenomyosis.html

Significant rise in hysterectomy complications observed following the FDA’s warning against power morcellator

A significant increase in major and minor complications following hysterectomy was noted in a large retrospective cohort study that was conducted after the US Food and Drug Administration (FDA) warned against the use of laparoscopic power morcellation during a hysterectomy in November 2014.

The study was published today April 11 in JAMA Surgery.

The warning was issued because of fear of dissemination of undiagnosed occult leiomyosarcoma in the benign fibroid mass.   

https://obgynupdated.blogspot.com/2018/04/significant-rise-in-hysterectomy.html

Addition of 24-chromosome microarray analysis to standard testing identifies a probable or definitive cause in over 90% of recurrent miscarriages

The new method of 24 Chromosome Microarray, or comprehensive chromosomal screening when added to the standard Recurrent Pregnancy Loss (RPL) evaluation of American Society for Reproductive Medicine (ASRM) could provide a probable or definitive cause in over 90% of patients reports the result of a small prospective cohort study published 1 April 2018 in Journal of Human Reproduction.

In the absence of definitive etiologies and treatment strategies, RPL is one of the most frustrating and difficult to treat entity in reproductive medicine. It affects 2%-5% of couples and a cause can be found only in 50% of the couples after undergoing the standard ASRM workup.

https://obgynupdated.blogspot.com/2018/04/addition-of-24-chromosome-microarray.html

A novel, single-use Foley’s catheter fixation device protects from accidental removal and trauma

Indwelling urinary catheters are very commonly used for inpatients in hospitals and people confined to bed in hospice and nursing homes. It is estimated that 25% of hospitalized patients have catheters placed during their hospital stay.

They are also associated with Urinary Tract Infections (UTI) and account for 70-80% of iatrogenic UTI in hospital and inpatient settings. But, genitourinary trauma is also common because of the inflated balloon during accidental pulling of Foley’s catheter.

https://obgynupdated.blogspot.com/2018/04/a-novel-single-use-foleys-catheter.html

Ulipristal Acetate effectively controls uterine bleeding in patients with symptomatic uterine leiomyomas

Nearly 50% of women with symptomatic uterine fibroid achieved amenorrhea with Ulipristal Acetate as compared to placebo, reports the results of small randomized control trial published in March issue of Journal of Obstetrics and Gynecology.

Leiomyomas are the most common indication for hysterectomy in the United States affecting nearly 70% of white women and more than 80% of black women of reproductive age. About a quarter or 50% of women experience symptoms, the most common being heavy and irregular uterine bleeding.

Many medical treatment options like nonsteroidal anti-inflammatory drugs (NSAIDs), levonorgestrel intrauterine devices, and oral and nonoral combination contraceptives are prescribed in the treatment of symptomatic fibroids but data about their efficacy is limited.

Other off-label drugs that are used for short-term management include gonadotropin-releasing hormone agonists and tranexamic acid.

This multicenter, randomized, double-blind, double-dummy, placebo-controlled, parallel-group phase 3, (NCT02147197) was conducted at 25 study centers across the United States.

Premenopausal women between 18-50 years of age with one or more discrete leiomyomas and uterine size 20 weeks of gestation with menorrhagia were included in the study. The researchers looked at the rate of and time to amenorrhea (no bleeding for the last 35 consecutive days of treatment) as the co-primary endpoints and Uterine Fibroid Symptoms and Quality of life (QoL) as the secondary endpoints.

Over a period of 2 years, 157 patients with similar demographics were randomized 1:1:1 to once-daily oral 5 mg ulipristal, 10 mg ulipristal, or placebo followed by a 12-week drug-free period.

Patients fared significantly better with both the doses of ulipristal, in terms of achieving amenorrhea 25 of 53 (47.2%) and 28 of 48 (58.3%) patients treated with 5 mg and 10 mg ulipristal, respectively achieved amenorrhea as compared with 1 of 56 (1.8%) of placebo-treated patients (both P <.001).

Patients on ulipristal also reported an improved quality of life and a decrease in the amount of blood loss. At the end of follow-up period decrease in volume of the leiomyomas was also observed in ulipristal treated groups as compared to placebo where an increase was noted.  

The small sample size and short duration of treatment were not enough to study the side effects but not a single patient discontinued the treatment because of side effects of the drug.

Other studies have shown that multiple 12-weeks courses of ulipristal (up to 8 coursed of 12 weeks duration each) is effective and well tolerated and maintains the efficacy and quality of life.

The authors concluded, “ulipristal may be useful for the medical management of abnormal uterine bleeding associated with uterine leiomyomas, especially for patients desiring uterine- and fertility-sparing treatment.”

Abstract

Full text

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News from ACOG 2018: Unexplained infertility may be an indicator of decreased ovarian reserve even in young women

Despite advances in diagnostic modalities in the infertile couples, the cause of infertility remains largely unexplained in 25% to 30% of couples. The treatment in these couples remains largely empirical.

The result of a small study presented at the ACOG 2018 by, Dr. Andrea Starostanko MD and Dr. Jonathan Ayers MD from Saint Joseph Mercy Hospital Department of Obstetrics and Gynecology, Ann Arbor, MI suggests that even in young women with unexplained infertility (UI) ovarian reserve should be evaluated as part of initial work up.

Institute for Reproductive Health

They looked at data from 343 nulligravid couples (18-34 years) who were unable to conceive after unprotected coitus for a period of 12 months. The couples underwent tubal patency test, ovulation study and anatomic status by mid-cycle TVUS, comprehensive semen analysis, and assessment of Decreased Ovarian Reserve (DOR) with serum Anti-Mullerian Hormone (AMH).

A cause of infertility was found in 142/343 (41%) couples with anovulation in 30%, anatomic abnormality in 9% and male factor in 6%.  In 201/343 (59%) of couples, no probable cause could be identified.

In these couples with UI, 118/201 women had serum AMH levels below the 95 percentile of age-appropriate value and in nearly 25% of women below the age of 35(53/201), the values were < 1.5.

The researchers concluded that: 

All women with UI should be investigated for ovarian reserve during the initial workup, irrespective of their age

Women who are diagnosed with DOR should seek consultation with a specialist for further treatment options

DOR may also be a harbinger of premature menopause and associated cardiovascular complications  

Abstract

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ACOG annual meeting kicks off today in Austin, Texas

The American College of Obstetricians and Gynecologists (ACOG) 2018 Annual Meeting kicks off today at Austin, Texas. This year's meeting is going to highlight the medical and surgical innovations in healthcare, with an emphasis on those that are practice-ready.

The meeting begins at 8 A.M. on April 27, 2018, with ACOG President Haywood L. Brown, MD, calling the meeting to order and providing a review of our profession and his presidential year. This will be followed by new Trifecta Clinical Seminars in which three experts will voice their opinions on the same topic at the same time and a roundtable conference thereafter on “The New Postpartum Visit: Beginning of Lifelong Health.”

Postpartum care has been a focus during Dr. Brown’s presidency. The “Redefining the Postpartum Visit” task force and the Committee on Obstetric Practice are expected to release a revised “Optimizing Postpartum Care” Committee Opinion in the coming weeks, which will propose a new postpartum care paradigm. The task force confronts two areas: Redesigning the postpartum visit and researching and highlighting the impact of pregnancy complications such as high blood pressure (preeclampsia) on long-term health

There will not be a dearth of educational and hands-on opportunities throughout the conference said Sandra Carson, MD, vice president of education for the ACOG and lead organizer of the meeting.

ACOG innovation Rodeo is a new event at the conference this year. Keeping in line with the ACOG’s well-earned reputation for producing original, entertaining, and engaging educational programming, the Rodeo features educational games, learning labs, digital activations, networking opportunities, and two virtual reality stations focusing on pre-operative, surgery, and postoperative components for vaginal hysterectomy. It will be open Thursday through Sunday.

Mobile apps will also be a major attraction during this event. Katherine Chen, MD, from the Department of Obstetrics, Gynecology, and Reproductive Science at the Icahn School of Medicine at Mount Sinai in New York City will deliver the John I Brewer Memorial Lecture, entitled Smart Phones, Tablets, and Phablets: Delivering Apps for the OB/GYN.

Aaron Caughey, MD, PhD, chair of the Department of Obstetrics and Gynecology and associate dean for Women's Health Research and Policy at the Oregon Health & Science University School of Medicine in Portland will present the initial results of the ARRIVE trial (NCT01990612), which refute the claim that induction of labor leads to higher cesarean section rates.

This year meeting also sees an increase in the number of flipped classrooms sessions, in which attendees receive educational materials about the topic prior to the meeting to review on their own before the session. During the live session, the focus is on discussions and collaborative work instead of lectures.

Looking forward to some interesting research and digital innovations in the field of obstetrics.

2018 ACOG ANNUAL MEETING PREVIEW

FDA approves a bedside test for assessing the risk of spontaneous preterm birth

QIAGEN won FDA approval for marketing its Novel PartoSure® point of care test for estimating the risk of spontaneous preterm birth in patients who present with symptoms of preterm labor. PartoSure represents a breakthrough in research and development of diagnostic tests for preterm birth.

Predicting preterm birth is a diagnostic challenge and nearly 85% of patients admitted to the hospital for threatened preterm labor (PTL) do not deliver within the next 7 days, resulting in unnecessary interventions.

This non-invasive strip test provides results in just 5 minutes or less and can be done at patient’s bedside. The sample collection procedure is simple and does not require a speculum examination or specialized equipment for sample analysis.

The PartoSure test is a rapid, qualitative test and detects the presence of placental alpha microglobulin-1 (PAMG-1) in cervicovaginal secretions. A positive test indicating that delivery is imminent within 7 days in pregnant women with signs and symptoms of early preterm labor, intact amniotic membranes and minimal cervical dilatation (<3 cm), between 24 weeks, 0 days and 34 weeks, 6 days gestation with a singleton gestation. 

Several studies have reported a higher positive and negative predictive value for PartoSure, as compared to other existing diagnostic tests. Furthermore, a positive PAMG-1 test was more than four times more reliable than a positive fFN test in predicting imminent spontaneous preterm delivery according to a study published August 2017 in Journal of Ultrasound in Obstetrics and Gynecology.

According to the American College of Obstetricians and Gynecologists (ACOG) 2016 Practice Bulletin on Management of PTL, the positive predictive value of a positive fetal fibronectin test result or a short cervix alone is poor and should not be used exclusively to direct management in the setting of acute symptoms.

The market approval of PartoSure adds to the already burgeoning QIAGEN’s comprehensive Sexual and Reproductive Health portfolio which includes AmniSure® ROM Test, the world’s leading assay for rupture of membranes (ROM), besides many others.

The combination of PartoSure and AmniSure gives QIAGEN two highly synergistic, biomarker targeted diagnostics for assessing the risk of two critical aspects of prenatal labor management. Both tests are leveraging the ability to assess respective risks quickly without the requirement of a reader.

“The FDA-approved PartoSure test will help clinicians assess which mothers face an imminent risk of preterm birth, which should reduce healthcare costs and benefit patients,” said Thierry Bernard, Senior Vice President and head of QIAGEN’s Molecular Diagnostics Business Area in a press release. “While a significant number of pregnant women experience symptoms of threatened preterm labor, as few as 3% actually progress to giving birth within a week of testing. Clinicians struggle to predict which symptomatic women will give birth prematurely and to decide on appropriate care. Discharging these patients carries a risk of a preterm delivery outside of the hospital but admitting them always incurs considerable costs and disruptions to the family – often unnecessarily. PartoSure has been proven to reduce the uncertainty."

PartoSure has already been in the market in more than 35 countries across Europe, the Middle East, Asia and Latin America and is expected to be available in the U.S. in 2018.

Product page

QIAGEN Press Release 

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Here is a video of the PartoSure Test

PartoSure IFU Video from PartoSure Test on Vimeo.

iFertracker- First Overnight Basal Body Temperature tracker to monitor the fertility

iFertracker™ by Raaing Medical is the first overnight fertility monitor that measures the core body temperature continuously throughout the night. It also simultaneously calculates and record the Basal Body Temperature (BBT) to predict the fertile window.

Usually, to measure the BBT a woman must use a special thermometer to record the temperature early morning each day at the same time before she gets out of bed. This task itself is tiresome and unreliable, sometimes a day is missed, or some error might occur.

iFertracker eliminates all this hassle and does all the work while the woman can sleep soundly throughout the night. It comes in beautifully packaged, with two CR2025 batteries (each battery is predicted to last for 45-60 days so the other is kept as spare one), a battery replacement tool, and 150 double-sided, single-use adhesive patches.

Setting up the iFertracker before the woman can start measuring the temperature is a very easy task. The woman has to simply download the free app to an Android or iOS cell phone and input all her menstrual cycle details along with her biometrics.

The device itself is very small and lightweight and has a very sleek, oblong design. It powers on automatically as soon as it comes in contact with body heat and a small blue light starts flashing indicating that Bluetooth capabilities are enabled. After once connected the iFertracker will recognize the user’s cell phone and will connect with it every time the app is opened.

To begin using, the woman places a new, double-sided adhesive patch on the oblong wearable thermometer and adhere it to the armpit. It is advisable to shave the area before putting on the device. The device turns on by itself and collects 20,000 data points in a single night, continuously monitoring the temperature as the user sleeps through the night. These are eventually uploaded to cloud and analyzed by an advanced algorithm to calculate the BBT.

The next morning, she removes the device and goes around with her morning routine. At her convenience, she opens the app on her smartphone and the device sync to it and starts downloading the temperature readings collected overnight.

In an event that internet connectivity is lost, or the user is very busy to open the app, the device has the ability to store data up to 10 days and it syncs with the app as soon as it is opened.

The iFertracker app displays the information collected in the form of graphs that are user-friendly and easy to understand. The graph color codes each phase of the cycle, including Menstruation, Follicular & Luteal phases, Fertile Window, and Ovulation day.

In addition to the display of last night’s BBT, the home screen informs the user about her fertility possibility and days until ovulation. The app also allows the user to input relevant event such as cervical mucus, mood, sexual activity, etc. The accuracy of prediction increase linearly with the duration of use as the tracker collects data over time and harness it to predict the fertility window and day of ovulation.

Besides getting pregnant this information can be used for natural family planning, hormone tracking during pregnancy or return to full fertility after delivery.

Raiing Medical also manufacture iThermonitor ™, the only wearable, wireless, clinically validated, and non-invasive core temperature thermometer.  It is worn similar to iFertracker and can be used in children and adults.

The iFertracker is available on Amazon or directly from Raiing Medical for $109. The adhesive patches are also available separately. 

Product page

Here is a video about how to track your BBT using iFertracker

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Addition of 24-chromosome microarray analysis to standard testing identifies a probable or definitive cause in over 90% of recurrent miscarriages

http://www.ucl.ac.uk/

The new method of 24 Chromosome Microarray, or comprehensive chromosomal screening when added to the standard Recurrent Pregnancy Loss (RPL) evaluation of American Society for Reproductive Medicine (ASRM) could provide a probable or definitive cause in over 90% of patients reports the result of a small prospective cohort study published 1 April 2018 in Journal of Human Reproduction.

In the absence of definitive etiologies and treatment strategies, RPL is one of the most frustrating and difficult to treat entity in reproductive medicine. It affects 2%-5% of couples and a cause can be found only in 50% of the couples after undergoing the standard ASRM workup.

This single-center study included 100 patients from a private RPL clinic from 2014 to 2017. The maternal age was between 26 to 45 years.

All 100 women had two or more pregnancy losses, with a complete evaluation for RPL as defined by the ASRM, and miscarriage tissue evaluated by 24-chromosome microarray analysis after their second or subsequent miscarriage.

In 95 of 100 patients, a probable or definitive cause of pregnancy loss was identified when 24-chromosome microarray analysis was combined with the standard ASRM RPL workup evaluation at the time of second or subsequent miscarriage.

The standard ASRM RPL workup done alone could only identify an abnormality or cause of miscarriage in 45 of 100 patients while 24-chromosome microarray analysis identified an abnormality in 67 of 100 patients when performed as the initial test on miscarriage tissue.

In only 5 of 100 patients, no cause could be found even after combined testing by ASRM RPL workup and 24-chromosome microarray analysis.

The authors concluded that combining the standard workup and genetic evaluation on miscarriage tissue obtained at the time of the second and subsequent pregnancy losses could offer much more answers towards the probable or definitive cause of RPL. It should be routinely offered to couples who have had two or more consecutive pregnancy losses.

Abstract

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A novel, single-use Foley’s catheter fixation device protects from accidental removal and trauma

Indwelling urinary catheters are very commonly used for inpatients in hospitals and people confined to bed in hospice and nursing homes. It is estimated that 25% of hospitalized patients have catheters placed during their hospital stay.

They are also associated with Urinary Tract Infections (UTI) and account for 70-80% of iatrogenic UTI in hospital and inpatient settings. But, genitourinary trauma is also common because of the inflated balloon during accidental pulling of Foley’s catheter.

Foleysafe by Cathetrix is a single use, catheter fixation device that is attached to the catheter. Upon pulling of the inflated catheter a cutting mechanism is immediately activated which severs the catheter, causing the retention balloon to deflate and thus preventing any trauma to the patient. It works well with both latex and silicone Foley’s catheter.

The product has gained CE and FDA type 1 clearance and is currently in the production phase. It is the debut product of Cathetrix, an innovative catheter securement devices company, developing and producing smart catheter fixations. It has joined with 3BY ltd for the production of Foleysafe.

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A quarter of stillbirths are preventable by increased obstetric surveillance

Placental insufficiency was identified as the lead cause of potentially preventable stillbirths, followed by medical complications of pregnancy and hypertensive disorders of pregnancy, reported the result of a small study conducted by Jessica M. Page, MD, of the University of Utah School of Medicine, and her colleagues. 

The stillbirth rate in the US was 5.96 per 1,000 births in 2013 and has remained stable since the last decade. Although it is much lower than the global rate of 18.4/1,000 births, it is higher than rates in other developed countries.

Currently, Finland has the lowest stillbirth rate of 2 per 1,000 births, while Pakistan has the highest rate of 43.1 per 1,000 births. Other countries with relatively low stillbirth rates included Norway, Denmark, and Singapore. 

The researchers conducted a secondary analysis of 512 stillbirths from the Stillbirth Collaborative Research Network with post-mortem data and placental histopathology. They identified 114 (22.3%) that were potentially preventable; 27 of those were included in more than one category, of which 23 fit into two categories and 4 fits into three categories.

In fact, one-third of stillbirths due to placental insufficiency had another cause identified as well. When the stillbirths due to placental insufficiency were analyzed further, it was seen that they increased with increasing gestational age, the most common window being after 37 weeks of gestation. The stillbirths due to other causes (potentially preventable and nonpreventable) did not increase with increasing gestational age.

But, the researchers did notice a significant increase in the proportion of potentially preventable stillbirths with increasing gestational age (P=.023). Notably, 39 out of 114 preventable stillbirths occurred after 37 weeks of gestation, when the risk of prematurity was at its minimal, had they been detected at risk of intrauterine death (IUD) and delivered.

When the researchers looked at the role played by race and ethnicity, they did not find any significant difference between various cohorts.

The majority of stillbirths in low resource setting can be preventable, while there is no clue regarding how to bring down the stillbirth rate in developed countries. There are few risk factors that increase the risk of stillbirths like smoking, obesity, advanced maternal age, and multiple gestations but it is not known that how far the risk can be lowered by modification of these factors.

Researchers are optimistic to get some clue regarding prediction of third-trimester stillbirths from data obtained from the Eunice Kennedy Shriver National Institute of Child Health and Human Development–sponsored Human Placenta Project.

The study has many limitations, but it also did include a large number of well-characterized stillbirths from racially, ethnic and geographically diverse population.

This study underscores the importance of close obstetric surveillance with nearly 25% of stillbirths deemed potentially preventable.

The study was published in February 2018 issue of Journal of Obstetrics and Gynecology and also presented as a poster at the Society for Maternal-Fetal Medicine’s 36th Annual Pregnancy Meeting, February 1–6, 2016, Atlanta, Georgia.

Full Text

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New approach to myomectomy: Transvaginal natural orifice transluminal endoscopic surgery

Natural orifice transluminal endoscopic surgery (NOTES) is a challenging minimally invasive procedure where ‘scarless’ abdominal surgeries are performed through an endoscope inserted through a natural orifice (mouth, anus, vagina, and urethra) and is considered as a less invasive approach to laparoscopic surgeries.

NOTES is considered a logical next step in the evolution of minimal invasive surgery, and the first NOTES procedure in humans is often considered to be a transgastric appendectomy performed in India in 2006 which was presented but not reported in manuscript form.

vNOTES is a natural orifice surgery performed through vaginal route. A look into history reveals that gynecologists have been performing colpotomies since years, adding their valuable experience towards NOTES surgeries and subsequent closure.

A recently published paper in January issue of Fertility and Sterility have demonstrated a new technique of performing myomectomy by this route and reports the technique and results of a small study involving 8 patients. Eight patients were treated transvaginally for intramural, subserosal, and pedunculated myomas.

The study was conducted at Gynecology department of a non-university teaching hospital in Belgium.

In case of the anterior myoma, anterior colpotomy was used to gain access to the peritoneal cavity, if the myoma was located posteriorly, a 2.5-cm posterior colpotomy was made under general anesthesia. The pouch of Douglas was opened and a vNOTES port was inserted transvaginally.

A pneumoperitoneum was created and the myoma was identified. With the use of conventional endoscopic instruments and a standard endoscope, all inserted through the vNOTES port, the uterine serosa was incised over the myoma and the myoma was resected. After achieving hemostasis, the uterine scar was sutured in two layers with the use of a standard absorbable suture or an autolocking suture.

 An adhesion-preventing barrier was applied over the uterine scar. The myoma was removed through the colpotomy in an endobag. The vNOTES port was removed and the colpotomy was sutured with the use of an absorbable suture.

The patients’ data collected included demographics, number of previous abdominal surgeries, myoma size, myoma weight, operating time, length of hospital stay, visual analog scale pain score, and serum hemoglobin drop.

All fibroids were successfully removed without any intraoperative or postoperative complications via vNOTES without converting to open or standard laparoscopic access. Patients were discharged within 24 hours, 2 of them went home in 12 hours.

In a developed setting, the surgical time can be reduced with the use of an autolocking suture and a commercially available vNOTES port, while in low resource setting it can be replaced by standard absorbable suture and a self-constructed gloveport, as clearly seen in the following video.

The authors concluded that vNOTES provides a new less invasive approach for the resection of myoma types 3–7 that are conventionally resected via laparotomy, laparoscopy, or transabdominal robotic surgery.

This was the first successful IDEAL (idea, development, exploration, assessment, long-term study) stage 1 study which confirmed the feasibility of vNOTES myomectomy. This novel approach not only provides a better cosmetic result than conventional laparoscopy but also improves patient comfort.

Larger studies are warranted in future. 

A new approach to ovarian cystectomy: Transvaginal natural orifice transluminal endoscopic surgery

Full Text 

Here is the video of stepwise explanation of the technique.

Fresh or frozen-embryo transfer results in similar pregnancy rates in women without PCOS

Episona.com

Healthy infertile women with no polycystic ovarian syndrome have the same ongoing pregnancy and live birth rates from IVF irrespective of whether the embryo was fresh or frozen reports the results of two recent clinical trials published in JAMA. 

Recent clinical trials have documented higher pregnancy and live birth rates with the transfer of frozen embryos as compared to fresh ones. A clinical review published in the Journal of Human Reproduction Update also favored “elective frozen embryo transfer (eFET) not only in terms of achieving higher pregnancy rates but, more importantly, also in terms of lower maternal and infant morbidity and mortality.”

The two current studies were conducted to see whether fresh frozen embryo transfer resulted in higher birthrates in women who do not have PCOS.

The first multicenter, randomized trial recruited 2157 women who were scheduled to undergo their first IVF cycles. They were randomly assigned to undergo either fresh-embryo transfer or embryo cryopreservation followed by frozen-embryo transfer. The maximum embryo transferred in each participant was two with the live birth rate as the primary outcome after the first embryo transfer.

There was no significant difference in terms of live birth rates in the frozen-embryo group and the fresh-embryo group (48.7% and 50.2%; P=0.50) respectively. Both the groups were also similar in terms of risks of obstetrical and neonatal complications, rates of implantation, clinical pregnancy, overall pregnancy loss, and ongoing pregnancy.

But, frozen embryo transfer did result in a significantly lower risk of the ovarian hyperstimulation syndrome than fresh-embryo transfer (0.6% vs. 2.0%; P=0.005).

The second study randomly assigned 782 healthy infertile women with no PCOS to receive either a frozen embryo or a fresh embryo on day 3 during their first or second IVF. In this study also, the pregnancy rates were comparable in both the groups, 36.3% in the frozen-embryo group 34.5% in the fresh-embryo group (P = .65).

The authors concluded that in women who do not have PCOS, the pregnancy rates are similar with fresh or frozen embryos. In healthy infertile women, probably the uterine environment was favorable for fresh embryos transfer. 

Abstract-NEJM

Abstract-NEJM

Abstract-JAMA

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FIGO celebrates the 50th anniversary of the first use of Anti-D Immunoglobulins to prevent Rh sensitization

Photo: Darren James

FIGO celebrated the 50^th anniversary of the first use of Anti-D Immunoglobulins to prevent Rh sensitization at the Regional Congress of Middle East and Africa (11 – 13 April, Intercontinental Hotel, Dubai Festival City).

The discovery of Anti-D Immunoglobulins 50 years ago was a medical breakthrough that resulted in a dramatic reduction in the incidence of Hemolytic Disease of the Fetus and Newborn (HDFN) in many parts of the world.

Prior to 1968, HDFN claimed some 10,000 infant lives a year in the U.S. alone. The U.S. FDA approved RhIG in April of that year. Dr. Vincent Freda, an obstetrician, and Dr. John Gorman, the Director of the Blood Bank, both at Columbia, conducted pioneering research that led to a breakthrough in disease prophylaxis (RhoGAM®), effectively eradicating the hemolytic disease of the newborn due to anti-Rh antibodies.

Marianne Cummins in Teaneck, NJ was first to receive Rho(D) immune globulin treatment on May 29, 1968, eventually giving birth to a healthy boy. The brand name of first immune globulin was "skymed" and was introduced by Ortho-Clinical Diagnostics, a subsidiary holding of Jskymed.

Professor Gerard Visser, Chairman of FIGO’s Standing Committee for Safe Motherhood and Newborn Health pointed out, “Anti-D Immunoglobulins have nearly eradicated HDFN in the developed world. However, the implementation of protocols for the sustained use of Anti-D has been insufficient in much of the developing world, resulting in some 300,000 infants dying or being severely handicapped annually, 50 years after its introduction.”

One of the issues that was addressed at the Regional Congress in Dubai continues Visser, “is how to meet these challenges and move forward with getting protocols for the use of Anti-D accepted and applied in more countries where HDFN remains a real problem.”

The prenatal protocol with Anti-D Immunoglobulins was introduced in the 1970s in the USA and Western European countries. It involves screening for all pregnant women and possible administration of Anti-D Immunoglobulins.

These two steps have led to a sharp drop in the incidence of HDFN in these countries and in many others. It has resulted in a reduction in the number of serious cases that triggered stillbirths or contributed to increased infant mortality and morbidity.

Currently, cases of HDFN registered annually in more developed countries are rare and Anti-D immunoglobulins are considered the standard of care for preventing Hemolytic Disease in all North America, Europe, and Australia.

In countries that do not yet have disease prevention protocols in force, up to 14 percent of the fetuses affected die at birth, whereas 50 percent of the newborns affected either die in their first days of life or suffer from brain damage.

Although Anti-D Immunoglobulins are on the World Health Organization’s List of Essential Medicines, many of the countries where this preventative treatment is most needed lack access to this prophylaxis, do not have appropriately trained medical personnel, or other resources needed to enact the necessary protocols.

An event was held at Columbia University on February 5^th to celebrate the 50th anniversary of FDA approval of Rho(D) Immune Globulin, brand named RhoGAM®.  Kedrion Biopharma and Columbia University Irving Medical Center jointly hosted a distinguished panel of pioneering scientists, physicians, and the first mother to receive Rho (D) Immune Globulin.

The panel also launched an unbranded global educational campaign to improve global awareness about the disease and treatment therapies available globally.

FIGO also dedicated one full session of the scientific programme to this topic at the Regional Congress in Dubai followed by a specific Stakeholders Meeting, both aimed at drawing attention to the critical issues that still exist.

Could perioperative NSAIDs treatment markedly reduce metastatic breast cancer recurrence?

Perioperative anti-inflammatory treatment could prevent or reduce the risk of secondary spread of breast cancer after the primary resection surgery according to a paper published April 11 in Journal of Science and Translational Medicine.

The study was conducted in mice but could offer an explanation for the resurgence of the tumor after primary surgery in humans too. It has been a long-known fact that after undergoing lumpectomy or mastectomy, there is metastatic recurrence elsewhere in the body after a year or two.

The cause of this is long been debated, some researchers taking it as the natural progression of disease while others propose that handling of the tumor during surgery release the cancerous cells in the circulation.

The researchers set up an experimental wound healing mice model who had breast cancer. They did not do any surgery or disturbed the primary tumor. The systemic inflammatory response to wound led to new tumor growth at the distant site, which was kept in check by the tumor-specific T cell response. Probably, the wound healing consumed all the T-cells that previously kept a check on tumor cells.

The researchers gave the mice NSAIDs for wound healing and noted that the growth of secondary metastasis was curbed considerably.

Earlier clinical studies have suggested that perioperative anti-inflammatory drugs reduce early metastatic recurrence in breast cancer patients, but no explanation was put forth for the cause.

A 2012 study particularly showed that breast cancer patients given the anti-inflammatory drug ketorolac during surgery were five times less likely to have their cancer spread than people who didn’t get the painkiller

“This represents the first causative evidence of surgery having this kind of systemic response,” Jordan Krall, the first author of the study and a researcher at the Massachusetts Institute of Technology's White Head Institute for Biomedical Research, said in a statement announcing the study's publication.

“Surgery is essential for treating a lot of tumors, especially breast cancer," Krall added. "But there are some side effects of surgery, just as there are side effects to any treatment. We’re starting to understand what appears to be one of those potential side effects, and this could lead to supportive treatment alongside surgery that could mitigate some of those effects.”

It’s not yet clear whether any specific NSAIDs will give more benefit than others, or what’s the best dose or timing to deliver the drug.

Professor Robert Weinberg, the new study’s senior author says, “Mice are not people and therefore this may not translate into clinical practice. Our paper is only intended to alert people to this possibility and to explore whether this mechanism operates as well in humans as we think it might.”

Scientist agrees that more research is needed to investigate an explanation as simple as this, as NSAIDs are routinely used in the peri and postoperative period to ease the pain.

Abstract

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