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MONACO: Controlled Ovarian Stimulation Versus Modified Natural Cycles in Poor Responders

Sponsor
University Hospital, Ghent (Other)
Overall Status
Recruiting
CT.gov ID
NCT04487925
Collaborator
(none)
208
Enrollment
1
Location
2
Arms
35.2
Anticipated Duration (Months)
5.9
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Drug: A single Gonadotropin-Releasing Hormone (GnRH) antagonist corifollitropin alfa (CFA) stimulation
  • Drug: Up to three modified natural cycles with Follitropin beta.
 Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
208 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized Comparison of One Controlled Ovarian Stimulation With Corifollitropin Alfa Versus up to Three Modified Natural Cycles in Expected and Established Poor Responders
Actual Study Start Date :
Jan 25, 2022
Anticipated Primary Completion Date :
Sep 30, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Number of good quality blastocysts after CFA stimulation vs. after a first MNC [On fifth day of embryonal development]

Secondary Outcome Measures

  1. Number of good quality blastocysts after CFA stimulation vs. after a second or third MNC [On fifth day of embryonal development]

  2. The relative number of blastocysts after ART, relative to the number of oocytes [On fifth day of embryonal development]

  3. The probability of having at least one blastocyst of good quality after ART [On fifth day of embryonal development]

Other Outcome Measures

  1. The probability of having an ongoing pregnancy [6 to 8 weeks gestational age]

  2. The time until ongoing pregnancy [6 to 8 weeks gestational age]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 44 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospital Ghent Gent Belgium 9000

Sponsors and Collaborators

  • University Hospital, Ghent

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT04487925
Other Study ID Numbers:
  • B6702020000326
First Posted:
Jul 27, 2020
Last Update Posted:
Mar 28, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Hormones
Follicle Stimulating Hormone

Study Results

No Results Posted as of Mar 28, 2022