Endometrial Gene Expression Profiles During Ovarian Stimulation With Recombinant FSH With or Without the Addition of Recombinant LH in Genuine Poor Responders

LHinPOR

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.

2023-05-01

2023-08-01

2024-08-01

Withdrawn

Early phase I

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'prospective randomized open-label cross-over study', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 0, 'type': 'ACTUAL'}}

2024-02-28