Effect of LH Supplementation on the Endometrial Gene Expression Profile in Poor Ovarian Responders (NCT05405686) | Clinical Trial Compass
WithdrawnPhase 4
Effect of LH Supplementation on the Endometrial Gene Expression Profile in Poor Ovarian Responders
Stopped: withdrawn due to practical reasons
0Started 2023-05-01
Plain-language 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.
Who can participate
Age range
35 Years – 40 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
endometrial gene expression
Timeframe: 7 days after finale oocyte maturation trigger