Controlled Ovarian Stimulation Versus Modified Natural Cycles in Poor Responders (NCT04487925) | Clinical Trial Compass
RecruitingPhase 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 range18 Years – 44 Years
SexFEMALE
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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.
What they're measuring
1
Number of good quality blastocysts after CFA stimulation vs. after a first MNC