Trial Information

Effect of Ulipristal Acetate Administration on Serum Progesterone Levels and Glycodelin-A Endometrial Pattern in Women Undergoing Controlled Ovulation Stimulation.

Controlled ovarian stimulation (COS) for FIV increases progesterone (P) and estradiol (E2)
serum levels in supraphysiologic concentrations at the end of follicular phase. Elevated
serum P levels leads to an accelerated endometrial maturation which interferes with the
dialogue between embryo and endometrium. It has been reported that serum progesterone levels
≥ 1.5 ng/ml on the last day of COS are related to a significant decrease in the ongoing
pregnancy rate following IVF cycles. Also, it has been reported a significant alteration in
the endometrial gene expression profile related to P elevated levels.

Glycodelin-A is an immunomodulatory glycoprotein synthesized by luteal-phase endometrial
epithelium and its expression seems to be related to the action of P. Because glycodelin-A
has immunosuppressive activity, it may facilitate the process of implantation and the
maintenance of pregnancy.

Objective: to evaluate the endometrial effect of Progesterone through Glycodelin-A
expression pattern on women exposed or not to ulipristal acetate in GnRH Antagonist cycles
using two different doses of FSH for ovarian controlled stimulation.

Methods: prospective controlled randomized study. It will be enrolling 16 oocytes donors
from Oocyte Donation Program of PROAR (a Reproductive Center of Rosario, Argentina). On day
3 of menstrual cycle FSH serum levels and antral follicular count (AFC) will be measure. If
those results fulfill with inclusions criteria, patients will be randomize for FSH 225UI or
300UI GnRH-Antagonist/ urinary FSH protocol. P serum levels will be measure every 48 hours
since at least 1 follicle ≥14 mm will be achieve until at least 1 follicle reach 19mm of
diameter. The next day of hCG administration a new P circulating will be measure and then
the patient will be randomize trough opaque envelopes for receive 30mg of ulipristal
acetate or placebo. An endometrial biopsy with Cornier´s Pipelle will be performing 3 and 5
days after hCG injection (hCG+3 and hCG+5 days) to evaluate endometrial dating and
Glycodelin-A expression pattern.

Statistical analysis: nominal variables will be analyzing using t-Student test and the
effect of ulipristal with ANOVA.