A randomized comparison of one controlled ovarian stimulation with corifollitropin alfa (CFA) versus up to three modified natural cycles (MNC) in expected and established poor responders

Phase 1

• Conditions: this study will compare the efficacy of two different strategies for the management of predicted low prognosis patients under stimulation for IVF/ICSI: up to three MNCs (Modified Natural Cycle) (control group) versus a single GnRH antagonist CFA (corifollitropin alfa) (intervention group).The study population is aimed at women with a clinical indication for Assisted Reproductive Technology (ART) with an expected low response to ovarian stimulation.; Therapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08]

• Registration Number: EUCTR2021-001835-22-BE
• Lead Sponsor: Ghent University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-13
• Last Update Posted: 8 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

The trial only includes women with a clinical indication for ART with an expected low response to ovarian stimulation. Expected low prognosis will be defined according to the POSEIDON classification, which stratifies patients according to whether they have an unexpected (groups 1 and 2) or expected (groups 3 or 4) inappropriate ovarian response to gonadotropin stimulation. This trial only includes patients fulfilling the criteria of groups 3 or 4:
• 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*)
* AMH value should not be older than 12 months.

Other 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
•Single embryo transfer (SET)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 300
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Basal FSH > 20 IU/L in the last 12 months
•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
•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 clinical trial of medicinal product
• Study Design: Not specified