Contemporary Outcomes of Fresh Donor Ovum Cycles Among Recipients Using Oral Estradiol and Vaginal Progesterone Gel

There is a lack of published data on the use of oral estradiol with vaginal progesterone gel to prepare the endometrium in fresh donor ovum cycles. To describe the efficacy of a regimen utilizing oral estradiol and vaginal progesterone gel among recipients of a contemporary oocyte donor program in a large regional ART center. This was an IRB-approved retrospective analysis of data from one MD in a large regional ART program after changing from an injectable protocol of I.M. estradiol valerate with I.M. progesterone, to oral estradiol, 2mg B.I.D. to T.I.D. in a step up protocol, with vaginal progesterone gel (Crinone 8%) B.I.D. Patients with residual ovarian function received a GnRH agonist. Transfers were performed on Day 5. Estradiol and progesterone serum levels were obtained at baseline, midcycle, and at the time of pregnancy test. Data were collected for all women under age 55 participating in our anonymous donor oocyte program who were treated with the new regimen during the period 1-Jan-2009 to 30-Jun-2011, and who were without severe pelvic factor infertility. Pregnancy rates and hormone levels were summarized with descriptive statistics. Pregnancy rate comparison between age groups used a 2-sided Fisher's Exact Test. Sixty-two recipients met the inclusion criteria (mean age 40.9 [SD 6.2] years, range 28-53, 76% ≥35). Mean donor age was 25.6 years (SD 3.2, range 20-33). Median baseline and midcycle estadiol levels were 21.3pg/mL and 416.3 pg/mL respectively. Median baseline and midcycle progesterone levels were 0.29 ng/dL and 0.21 ng/dL respectively. The mean midcycle endometrial thickness prior to progesterone application was 10.5 mm (SD 1.8). The mean number of embryos transferred was 2.0 (SD 0.6). The positive pregnancy rate was 48/62 (77.4%), with no significant difference in pregnancy rates between patients ≥35 and <35 years of age (78.7% vs 73.3%, P=0.73). The clinical pregnancy rate was 44/62 (71.0%) and the ongoing pregnancy rate was 41/62 (66.1%). Preparing the endometrium with oral estradiol and vaginal progesterone gel among recipients treated in a contemporary donor oocyte program is highly effective and associated with a 2X higher pregnancy rate compared to cycles reported in a previous decade-old trial (Gibbons et al. Fertil Steril 1998) using estradiol patches with vaginal progesterone gel.