Controlled Ovarian Stimulation Versus Modified Natural Cycles in Poor Responders

IVF Clinical Trial

— MONACO  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04487925
• Other study ID #: B6702020000326
• Status: Recruiting
• Phase: Phase 4
• Start date: January 25, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2023
• Source: University Hospital, Ghent
• Contact: Sara Somers, MSc
• Phone: 0032 9 332 30 48
• Email: studieco.vrouwenkliniek[@]uzgent.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 208
• Est. completion date: December 31, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 44 Years

Eligibility

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.

Related Conditions & MeSH terms

• IVF
• Ovarian Reserve
• Poor Responders

Intervention

Drug:
• A single Gonadotropin-Releasing Hormone (GnRH) antagonist corifollitropin alfa (CFA) stimulation
CFA will be administered in combination with Follitropin beta.
• Up to three modified natural cycles with Follitropin beta.
Follitropin beta in a low dose will be given.

Locations

Country	Name	City	State
Belgium	University Hospital Ghent	Gent

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The probability of having an ongoing pregnancy		6 to 8 weeks gestational age
Other	The time until ongoing pregnancy		6 to 8 weeks gestational age
Primary	Number of good quality blastocysts after CFA stimulation vs. after a first MNC		On fifth day of embryonal development
Secondary	Number of good quality blastocysts after CFA stimulation vs. after a second or third MNC		On fifth day of embryonal development
Secondary	The relative number of blastocysts after ART, relative to the number of oocytes		On fifth day of embryonal development
Secondary	The probability of having at least one blastocyst of good quality after ART		On fifth day of embryonal development