Comparing two methods for ovarian stimulation in women with poor response
A Randomized Comparison of One Controlled Ovarian Stimulation With Corifollitropin Alfa Versus up to Three Modified Natural Cycles in Expected and Established Poor Responders
This study is testing two different ways to stimulate the ovaries in women with low egg supply during IVF to see which method works better.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 208 (estimated) |
| Ages | 18 Years to 44 Years |
| Sex | Female |
| Sponsor | University Hospital, Ghent Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Ghent) |
| Trial ID | NCT04487925 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a prospective, randomized, single-center phase 4 intervention that aims to evaluate the effectiveness of two different ovarian stimulation strategies for women predicted to have a poor response during IVF/ICSI. Participants will be assigned to either receive up to three modified natural cycles or a single administration of a GnRH antagonist corifollitropin alfa. The study focuses on women aged 18 to 45 with specific criteria indicating poor ovarian reserve, as defined by the POSEIDON criteria. The goal is to determine which approach yields better outcomes for these patients.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 to 45 with poor ovarian reserve as defined by the POSEIDON criteria.
Not a fit: Patients with untreated thyroid dysfunction, tumors, or those currently using certain medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve IVF outcomes for women with poor ovarian response.
How similar studies have performed: Other studies have explored ovarian stimulation methods, but this specific comparison is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Ghent
- University Hospital Ghent — Ghent, Belgium (Recruiting)
Study contacts
- Principal investigator: Dominic Stoop, MD, PhD — University Hospital, Ghent
- Study coordinator: Sara Somers, MSc
- Email: studieco.vrouwenkliniek@uzgent.be
- Phone: 0032 9 332 30 48
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.