Status:
RECRUITING
Controlled Ovarian Stimulation Versus Modified Natural Cycles in Poor Responders
Lead Sponsor:
University Hospital, Ghent
Conditions:
Ovarian Reserve
Poor Responders
Eligibility:
FEMALE
18-44 years
Phase:
PHASE4
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 25 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
208 Patients enrolled
Trial Details
Trial ID
NCT04487925
Start Date
January 25 2022
End Date
December 31 2024
Last Update
May 9 2024
Active Locations (1)
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1
University Hospital Ghent
Ghent, Belgium, 9000