RecruitingPhase 4NCT04487925

Controlled Ovarian Stimulation Versus Modified Natural Cycles in Poor Responders

A Randomized Comparison of One Controlled Ovarian Stimulation With Corifollitropin Alfa Versus up to Three Modified Natural Cycles in Expected and Established Poor Responders

Sponsor

University Hospital, Ghent

Enrollment

208 participants

Start Date

Jan 25, 2022

Study Type

INTERVENTIONAL

Conditions

Ovarian Reserve IVF Poor Responders

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).

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 44 Years

Inclusion Criteria8

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 Criteria9

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.