Gonadotropin Releasing Hormone Agonist (GnRHa) Versus Estrogen and Progesterone for Luteal Support in High Responders

• Status: Recruiting
• Trial end date: 2021-09-30
• Target enrollment: 0
• Participant gender: Female

Summary

Gonadotropin Releasing Hormone agonist (GnRHa) triggering is used as an alternative to human chorionic gonadotropin (hCG) in GnRH antagonist protocol to eliminate the risk of ovarian hyperstimulation syndrome (OHSS). However, its main disadvantage is a significantly lower pregnancy rate, hypothesized to result from a process called "luteolysis" (demise of the corpora lutea). In order to preserve a high pregnancy rates, several luteal support regimens were investigated, including an intensive estrogen and progesterone supplementation and a daily GnRHa treatment. However, no study, so far, compared the efficacy of these two regimens. Our aim is to compare the efficacy of GnRHa versus estrogen and progesterone supplementation for luteal phase support in high responders following GnRHa triggering.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assaf-Harofeh Medical Center
• Treatments: 11-hydroxyprogesterone; 17 alpha-Hydroxyprogesterone Caproate; Estradiol; Nafarelin; Progesterone

Criteria

Inclusion Criteria:

• High responder patients, defined as either reaching a serum estradiol levels of ≥ 3500 pg/ml on the day of trigger or having ≥ 15 oocytes retrieved.

• Increased risk for OHSS (PCOS, previous history of OHSS, high antral follicle count (AFC) etc.).

Exclusion Criteria:

• Repeated implantation failure (3 or more previous failed embryo transfer cycles while transferring good quality embryos).

• Oocyte donation, fertility preservation or Freeze all (freezing all the embryos) cycles.

• Moderate to severe endometriosis

• An evidence of hydrosalpinx