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

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04487925

Acronym

MONACO

Enrollment

208

Registered

2020-07-27

Start date

2022-01-25

Completion date

2024-12-31

Last updated

2024-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

IVF, Ovarian Reserve, Poor Responders

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 stimulation for IVF/ICSI: up to three MNC cycles (group 1) versus a single GnRH antagonist CFA (group 2).

Interventions

DRUGA single Gonadotropin-Releasing Hormone (GnRH) antagonist corifollitropin alfa (CFA) stimulation

CFA will be administered in combination with Follitropin beta.

DRUGUp to three modified natural cycles with Follitropin beta.

Follitropin beta in a low dose will be given.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 44 Years

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.

Design outcomes

Primary

Measure	Time frame
Number of good quality blastocysts after CFA stimulation vs. after a first MNC	On fifth day of embryonal development

Secondary

Measure	Time frame
Number of good quality blastocysts after CFA stimulation vs. after a second or third MNC	On fifth day of embryonal development
The relative number of blastocysts after ART, relative to the number of oocytes	On fifth day of embryonal development
The probability of having at least one blastocyst of good quality after ART	On fifth day of embryonal development

Other

Measure	Time frame
The probability of having an ongoing pregnancy	6 to 8 weeks gestational age
The time until ongoing pregnancy	6 to 8 weeks gestational age

Countries

Belgium

Contacts

Primary ContactSara Somers, MSc

studieco.vrouwenkliniek@uzgent.be0032 9 332 30 48

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026