Controlled Ovarian Stimulation Versus Modified Natural Cycles in Poor Responders (NCT04487925) | Clinical Trial Compass
UnknownPhase 4
Controlled Ovarian Stimulation Versus Modified Natural Cycles in Poor Responders
Belgium208 participantsStarted 2022-01-25
Plain-language summary
This is a prospective, randomized, single center, phase 4 controlled trial. The study will compare the efficacy of two different strategies for the management of predicted poor response patients under stimulation for IVF/ICSI: up to three MNC cycles (group 1) versus a single GnRH antagonist CFA (group 2).
Who can participate
Age range
18 Years – 44 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:
* Informed consent form (ICF) dated and signed.
* Age ≥18 and \<45 years old.
* Body Mass Index (BMI) ≥18.5 Kg/m² and \<35 Kg/m².
* Regular menstrual cycles (between 21 and 35 days).
* Two ovaries present.
* Current pregnancy wish.
* Poor responders as defined according to the POSEIDON criteria:
POSEIDON Group 3: patients \< 35 years with poor ovarian reserve pre-stimulation parameters (AFC \<5 or AMH \<1.2 ng/mL); POSEIDON Group 4: patients ≥35 years with poor ovarian reserve pre-stimulation parameters (AFC \<5 or AMH \<1.2 ng/mL).
Exclusion Criteria:
* Simultaneous participation in another clinical study.
* Untreated and uncontrolled thyroid dysfunction.
* Tumors of the ovary, breast, uterus, pituitary or hypothalamus.
* Abnormal (not menstrual) vaginal bleeding without a known/diagnosed cause.
* Ovarian cysts or enlarged ovaries.
* Malformations of the reproductive organs.
* Current use of oral contraceptives, anti-psychotics, anti-epileptics or chemotherapy.
* Previous antibiotic hypersensitivity reactions (streptomycin and/or neomycin).
* Patients who undergo preimplantation genetic testing (PGT), fertility preservation or oocyte donation.
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
Number of good quality blastocysts after CFA stimulation vs. after a first MNC