Status:
WITHDRAWN
Effect of LH Supplementation on the Endometrial Gene Expression Profile in Poor Ovarian Responders
Lead Sponsor:
CRG UZ Brussel
Collaborating Sponsors:
Merck KGaA, Darmstadt, Germany
Conditions:
Poor Response to Ovulation Induction
Eligibility:
FEMALE
35-40 years
Phase:
PHASE4
Brief 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...
Detailed Description
This is a prospective randomized open-label cross-over study, in which patients will be randomized to either start in the control group or in the study group. Participants will undergo both treatments...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05405686
Start Date
May 1 2023
End Date
August 1 2024
Last Update
February 28 2024
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