Controlled Ovarian Stimulation Versus Modified Natural Cycles in Poor Responders

Phase 4

Recruiting

• Conditions: IVF; Ovarian Reserve; Poor Responders
• Interventions: Drug: Up to three modified natural cycles with Follitropin beta.; Drug: A single Gonadotropin-Releasing Hormone (GnRH) antagonist corifollitropin alfa (CFA) stimulation

• Registration Number: NCT04487925
• Lead Sponsor: University Hospital, Ghent

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-22
• Study First Submitted QC: 2020-07-22
• Study First Posted: 2020-07-27
• Study Start: 2022-01-25
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-08
• Last Update Posted: 2024-05-09
• Primary Completion: 2024-09-30
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 208

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Up to 3 modified natural cycles	Up to three modified natural cycles with Follitropin beta.	-
Controlled ovarian stimulation	A single Gonadotropin-Releasing Hormone (GnRH) antagonist corifollitropin alfa (CFA) stimulation	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University Hospital Ghent; 🇧🇪 Gent, Belgium