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

May 8, 2024 updated by: University Hospital, Ghent

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

208

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 44 years (Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Up to 3 modified natural cycles
Drug: Up to three modified natural cycles with Follitropin beta.
Follitropin beta in a low dose will be given.
Experimental: Controlled ovarian stimulation
Drug: A single Gonadotropin-Releasing Hormone (GnRH) antagonist corifollitropin alfa (CFA) stimulation
CFA will be administered in combination with Follitropin beta.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Ghent

Investigators

  • Principal Investigator: Dominic Stoop, MD, PhD, University Hospital, Ghent

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 25, 2022

Primary Completion (Estimated)

September 30, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

July 22, 2020

First Submitted That Met QC Criteria

July 22, 2020

First Posted (Actual)

July 27, 2020

Study Record Updates

Last Update Posted (Actual)

May 9, 2024

Last Update Submitted That Met QC Criteria

May 8, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BC-09933

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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