Controlled Ovarian Stimulation Versus Modified Natural Cycles in Poor Responders

Last updated: May 8, 2024
Sponsor: University Hospital, Ghent
Overall Status: Active - Recruiting

Phase

4

Condition

In Vitro Fertilization

Ovarian Function

Treatment

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

Up to three modified natural cycles with Follitropin beta.

Clinical Study ID

NCT04487925
BC-09933
  • Ages 18-44
  • Female

Study 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).

Eligibility Criteria

Inclusion

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 reservepre-stimulation parameters (AFC <5 or AMH <1.2 ng/mL).

Exclusion

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 oroocyte donation.

Study Design

Total Participants: 208
Treatment Group(s): 2
Primary Treatment: A single Gonadotropin-Releasing Hormone (GnRH) antagonist corifollitropin alfa (CFA) stimulation
Phase: 4
Study Start date:
January 25, 2022
Estimated Completion Date:
December 31, 2024

Connect with a study center

  • University Hospital Ghent

    Gent, 9000
    Belgium

    Active - Recruiting

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