IVF Clinical Trial
— MONACOOfficial 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
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).
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. |
Country | Name | City | State |
---|---|---|---|
Belgium | University Hospital Ghent | Gent |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Ghent |
Belgium,
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 |
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