Objective: To evaluate the effectiveness of transdermal E(2) administration in the luteal phase of IVF/ICSI cycles.
Design: Prospective, open-label, randomized clinical trial.
Setting: University-affiliated assisted reproduction center.
Patients: 1) Pilot trial to test serum E(2) behaviour during the luteal phase in women undergoing agonist as well as antagonist protocol; 2) women undergoing IVF/ICSI with good-quality embryos available.
Intervention(s): One hundred seventy-six patients were randomized by random number list on the day of embryo transfer to either: 1) progesterone (P) only as luteal support (200 mg bid starting the following night after oocyte retrieval); or 2) E(2) and P combined, applying E(2) patches (100 microg/day) twice per week beginning on the day of embryo transfer with P, as in the P-only group.
Main outcome measure(s): The primary outcome was implantation rate per embryo transfer; secondary outcome variables were pregnancy rate per embryo transfer, early pregnancy loss, multiple pregnancy rate, and midluteal P and E(2) levels.
Result(s): Hormonal levels did not differ between groups. There were no statistically significant differences in terms of implantation rate (34.9% [51 of 146] vs. 28.9% [41 of 142]), ongoing pregnancy rate 42% ([34 of 81] vs. 41.8% [33 of 79]), early pregnancy loss (15% [6 of 40] vs. 13.2% [5 of 38]), or multiple pregnancy rate (28.6% [12 of 42] vs. 24.4% [10/41]) in patients receiving P versus E(2) + P.
Conclusion(s): The addition of transdermal E(2) to the luteal-phase P support of IVF cycles did not improve cycle outcomes in terms of implantation and pregnancy rates.