Controlled Ovarian Stimulation Versus Modified Natural Cycles in Poor Responders
NCT ID: NCT04487925
Last Updated: 2024-05-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
208 participants
INTERVENTIONAL
2022-01-25
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Up to 3 modified natural cycles
Up to three modified natural cycles with Follitropin beta.
Follitropin beta in a low dose will be given.
Controlled ovarian stimulation
A single Gonadotropin-Releasing Hormone (GnRH) antagonist corifollitropin alfa (CFA) stimulation
CFA will be administered in combination with Follitropin beta.
Interventions
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A single Gonadotropin-Releasing Hormone (GnRH) antagonist corifollitropin alfa (CFA) stimulation
CFA will be administered in combination with Follitropin beta.
Up to three modified natural cycles with Follitropin beta.
Follitropin beta in a low dose will be given.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
44 Years
FEMALE
No
Sponsors
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University Hospital, Ghent
OTHER
Responsible Party
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Principal Investigators
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Dominic Stoop, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Ghent
Locations
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University Hospital Ghent
Ghent, , Belgium
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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BC-09933
Identifier Type: -
Identifier Source: org_study_id
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