Controlled Ovarian Stimulation Versus Modified Natural Cycles in Poor Responders (MONACO)

Ghent University Hospital (UZ)

Status and phase

Enrolling

Phase 4

Conditions

IVF

Ovarian Reserve

Poor Responders

Treatments

Drug: Up to three modified natural cycles with Follitropin beta.

Drug: A single Gonadotropin-Releasing Hormone (GnRH) antagonist corifollitropin alfa (CFA) stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT04487925

BC-09933

Details and patient eligibility

About

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).

Enrollment

208 estimated patients

Sex

Female

Ages

18 to 44 years old

Volunteers

No Healthy Volunteers

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.