Prospective randomized trial to evaluate the efficacy of a vaginal ring releasing progesterone for IVF and oocyte donation

Abstract

A polysyloxane vaginal ring containing 1g of natural progesterone was developed as luteal supplementation for women treated with IVF-embryo transfer and for agonadal women participating in an oocyte donation programme. The ring provides continuous release of progesterone (10-20 nmol/l) for 90 days. The efficacy of this form of progesterone supplementation was evaluated in two multicentre prospective randomized trials. IVF-embryo transfer trial: After oocyte aspiration, 505 women were randomly allocated to progesterone supplementation with vaginal ring or i.m. progesterone (50 mg/day). The clinical pregnancy rate was 36.6% in both groups. Implantation rate was 15.9% in the vaginal ring and 16.0% in i.m. progesterone. Oocyte donation trial: After endometrial proliferation with micronized oestradiol, 153 women were allocated to progesterone replacement with a vaginal ring or i.m. progesterone (100 mg/day). Clinical pregnancy rate was 39.8 and 28.6% respectively. Implantation rate was significantly higher with the vaginal ring compared with i.m. progesterone (19.9 and 11.6% respectively, P = 0.006). The vaginal ring is a novel development which provides continuous release of progesterone for 90 days. In IVF-embryo transfer, its effectiveness is similar to daily i.m. injections. In oocyte donation the ring provides a progestative milieu which improves the implantation rate and eliminates the discomfort of daily i.m. injections.

Pilot study evaluating a progesterone vaginal ring for luteal-phase replacement in donor oocyte recipients

“…The clinical pregnancy rates for the P vaginal ring were 36.6% and 39.8% for fresh IVF and fresh oocyte donation, respectively, as compared with 36.6% and 28.6% for the standard IM protocol for fresh IVF and fresh oocyte donation, respectively (13).…”

“…To our knowledge, this was the first use of a P vaginal ring in the United States for luteal support, although researchers in other countries have evaluated similar P-releasing rings in IVF and donor oocyte candidates (13,14). The primary objective of this phase II pilot study was to evaluate, in women with clinical or medically induced agonadism, the rates of adequate endometrial transformation with a P vaginal ring or a P vaginal gel in donor oocyte recipients.…”

Progesterone Vaginal Ring for Luteal Support

“…The clinical pregnancy rates for the VR progesterone in the study by Zegers-Hochchild et al were 36.6 and 39.8 % for fresh IVF and fresh oocyte donation, respectively. In the same study, the clinical pregnancy rates are reported as 36.6 and 28.6 % for the standard IM protocol for fresh IVF and fresh oocyte donation, respectively [29].…”

“…A RCT performed in South America compared the vaginal progesterone ring to intramuscular progesterone for use in both IVF and oocyte donation cycles. They report an increased, but not significant clinical pregnancy rate and statistically significant increased implantation rate with the vaginal ring (VR) [29]. The clinical pregnancy rates for the VR progesterone in the study by Zegers-Hochchild et al were 36.6 and 39.8 % for fresh IVF and fresh oocyte donation, respectively.…”

Luteal supplementation in in vitro fertilization: more questions than answers

“…In the other trial, the study was conducted in oocyte recipients, and the ring proved to be associated with a better implantation rate (37).…”