News from ASRM

October 23, 2015

The results of a new study on Vitamin D and pregnancy outcome. Plus, Is foam the future of nonsurgical female sterilization? And: Choosing a GnRH dose for ovarian stimulation

Does Vitamin D influence pregnancy outcome?

Results of a study supported by the National Institutes of Health (NIH) point to a positive role for maternal vitamin D levels in pregnancy outcomes. Presented at the 71st annual meeting of the American Society for Reproductive Medicine, the data point to a need for additional research about the role that the vitamin might play in gestation.

Presented by NIH scientist Sunni Mumford, PhD, the findings are from a secondary analysis of the EAGer Trial, a multicenter, block-randomized, placebo-controlled trial. EAGer was designed to evaluate the effect of low-dose aspirin initiated before conception on pregnancy outcomes in women with a history of miscarriage.

The 1228 women in EAGeR were aged 18 to 40 and all had experienced 1 or 2 miscarriages, had no history of infertility or gynecologic disorders, and intended to become pregnant again. At baseline, participants’ serum vitamin D levels were measured. Rates of pregnancy on spot urine clinic pregnancy tests, chemical pregnancy loss (positive hCG but not clinical evidence of pregnancy; n=56), and clinical pregnancy loss on ultrasound (n=133) then were tracked. 

Investigators used generalized linear models adjusted for age, body mass index (BMI), and characteristics of the prior loss to estimate relative risk (RR) and 95% confidence intervals (CIs) for live birth and pregnancy loss. Inverse probability weights also were used to control for potential selection bias introduced by restricting to women who became pregnant.

At baseline, 2% (17) of the women had deficient vitamin D levels (<30 nmol/L) and 12% (148) had inadequate levels (30-49 nmol/L). A positive, though clinically minimal, association was seen between vitamin D levels and live birth (RR 1.03, 95% CI 1.01, 1.05 per 10 nmol/L). Vitamins D levels also were inversely associated with pregnancy loss (RR 0.95, 95% CI 0.91, 1.00 per 10 nmol/L) and specifically clinical loss (RR 0.94, 95% CI 0.88, 1.00 per nmol/L). Discussing the findings at ASRM, Dr. Mumford noted that lower BMI, white race, higher education, and having a blood draw in the summer all were characteristics in the women that were associated with adequate vitamin D levels.

 

Mumford SL, Matyas RA, Silver RM, et al. Vitamin D and pregnancy loss and live birth: results from the Effects of Aspirin in Gestation and Reproduction (EAGeR) trial. O-139. Presented Tuesday, October 20, 2015 at 11:15 a.m.

 

 

Is foam the future of nonsurgical female sterilization?

Data from an animal study supported by the Bill and Melinda Gates Foundation suggest that polidocanol foam may be promising as a method of nonsurgical permanent female sterilization. Presented at the 71st annual meeting of the American Society for Reproductive Medicine, the research was performed on baboons and, the authors said, supports investigation of the transcervical approach in women.

Jeffrey Jensen, MD, of Oregon Health Sciences University described the findings from the study of a cohort of 22 baboons at the Oregon National Primate Research Center. All were health and regularly cycling and their tubal patency was determined with hysterosalpingogram. Five of the animals were treated with 20 mL of 5% polidocanol foam followed by 1 mL of saline containing 100 mg doxycycline, 4 received 3% polidocanol foam plus the 5% doxycycline, 4 received 3% polidocanol foam plus 0.01% benzalkonium chloride, and 9 received no additional treatment. All of the animals received an intramuscular injection of depot medroxyprogesterone acetate (DMPA) (2 mg/kg) after the treatment.

The baboons were then socially housed with males of proven fertility and observed for resumption of menstrual cyclicity and mating, which occurred in all females. The primary outcome was pregnancy within 6 months of resumption of menses.

After 6 months 78% of control females became pregnant compared with 20% of the animals who received 5% polidocanol foam and 5% doxycycline, 25% of those who received 3% polidocanol foam and 3% doxycycline, and 50% of the animals that received 3% polidocanol foam and benzalkonium chloride.  After 6 more months of exposure, no other pregnancies occurred in the treated animals, including 5 females in the control group that had become pregnant in the first 6 months, been given abortions and then were treated with 5% polidocanol foam, doxycycline and DMPA. The cumulative 6-month failure rate for 5% polidocanol foam plus doxycycline was 10% (P<0.05).

 

Jensen J, Hanna C, Yao S, et al. Polidocanol foam for nonsurgical permanent female contraception: initial trial in baboons. O-95. Presented Tuesday, October 20, 2015, 12:15 p.m.

 

 

Choosing a GnRH dose for ovarian stimulation

Increasing the daily dosage of gonadotropins in women who do not respond to standard ovulation induction protocols may not result in better fertility rates, according to results of a randomized, prospective trial presented at the 71st annual meeting of the American Society for Reproductive Medicine. Data from a study conducted by Turkish investigators who looked at the impact of 3 different doses of GnRH antagonists in patients undergoing in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI).

In the study, 95 women with poor ovarian response were randomized to one of three different doses of gonadotropins during ovarian stimulation. Thirty-one patients received 225 IU HP-hMG+225 IU rFSH, 31 received 150 IU HP-hMG+150 IU rFSH, and 33 of the women received 75 IU HP-hMG+75 IU HP-hMG+5 mg letrozole. All transferred embryos were Grade 1 according to morphologic classification.

The groups did not differ significantly in age, body mass index, infertility period, or day-3 E2, FSH, prolactin, or serum testosterone levels. Statistically significant differences also were lacking in length of ovulation induction, number of oocytes retrieved, number of MII oocytes, number of fertilized oocytes, fertilization rate, number of transferred embryos, and in rates of cycle cancellation and chemical and clinical pregnancy (all P>0.05). The rate of chemical pregnancy was higher in the group that received letrozole, although not statistically significantly so (P=0.83).

The authors concluded that using mild stimulation with letrozole is as effective as using higher doses. Increasing the dosage does not improve the number of MII oocytes, fertilization rate, number of transferred embryos, or chemical and clinical pregnancy rates.

 

Bastu E, Dural O, Yasa C, et al. Randomized prospective trial comparing three doses of GnRH antagonist protocol in patients with poor ovarian response. O-127. Presented Tuesday, October 20, 2015, 11:15 a.m.