The Effect of LH Supplementation on the Endometrial Gene Expression Profile During Ovarian Stimulation in Poor Ovarian Responders

• Status: Not yet recruiting
• Trial end date: 2024-08-01
• Target enrollment: 0
• Participant gender: Female

Summary

This is a prospective randomized open-label cross-over study. Poor responder patients will undergo two ovarian stimulation cycles. One with recombinant follicle stimulation hormone (FSH), and an other stimulation with recombinant FSH and recombinant luteinizing hormone (LH). In both groups, a freeze-all strategy will be applied and an endometrial biopsy will be taken 7 days after final oocyte maturation trigger. Endometrial gene expression analysis will be performed on both biopsies. After completion of both treatment cycles, a frozen embryo transfer of a single embryo will be performed.

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

Details

• Lead Sponsor: CRG UZ Brussel
• Collaborator: Merck Sharp & Dohme LLC
• Treatments: Follicle Stimulating Hormone

Criteria

Inclusion Criteria:

Age 35-40 years Undergoing IVF/ICSI BMI ≥ 19 and ≤ 30 AMH <1.2 ng/mL Previous conventional ovarian stimulation (OS) with < 4 metaphase II (MII) oocytes Regular menstrual cycle (26-35 days) Non-smokers Acceptance to do 2 consecutive ovarian stimulation cycles (between 1-6 months) Signed informed consent

Exclusion Criteria:

Endometriosis > rAFS grade II Testicular sperm extraction Recurrent miscarriage (>2 previous miscarriages) Ovarian stimulation for pre-implantation genetic testing (PGT-A/M) Medical/social oocyte vitrification In vitro maturation (IVM) Untreated auto-immune, endocrine or metabolic disorders Asherman's syndrome