Evaluating Pulsatile Intravenous FSH Versus Daily Subcutaneous Injections to Improve Fertility in Women with Obesity and Diminished Ovarian Reserve

What This Trial Is About

Researchers are investigating the use of pulsatile intravenous Follicle Stimulating Hormone FSH administration to address reproductive issues in women with obesity and diminished ovarian reserve. The study aims to correct the Reprometabolic Syndrome luteal deficiency and improve follicle development and hormone levels by comparing pulsatile FSH delivery to the conventional daily FSH injection. This proof-of-concept study focuses on hormone output and ovarian environment rather than overall metabolic health or pregnancy complications. Participants will receive two treatment cycles in a randomized crossover design one with conventional daily subcutaneous FSH injections and one with pulsatile intravenous FSH delivered via a portable infusion pump every 90 minutes. Both treatment cycles use the same daily FSH dose, with hormonal suppression of endogenous gonadotropins using a GnRH antagonist. A baseline ultrasound and hormone testing confirm eligibility before stimulation, and a one-month washout period separates the two cycles. During the study, participants will undergo hormone monitoring, ultrasounds, and laboratory tests to measure outcomes such as urinary progesterone levels, number of eggs retrieved, and follicle development. The study will assess hormone levels, follicle fluid and granulosa cell gene expression, and ovarian response over approximately four months. Participants are asked to postpone conception during the first cycle and will be closely monitored throughout the treatment and assessment periods.

Use of Pulsatile Intravenous FSH to Mitigate Reprometabolic Syndrome