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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
EU CTIS ID: 2023-509094-23-00
What this study is testing
to compare the probability of having at least one good quality blastocyst after CFA stimulation versus the probability of having at least one good quality blastocyst after a first MNC, in women with a clinical indication for ART and an expected low response to ovarian stimulation. Good quality is defined by the Gardner score 5AA, 5AB or 5BA.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
- 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
You likely can't join if
- 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
See the full eligibility criteria
- 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.
- 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)
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.