Follicular Phase Stimulation vs. Luteal Phase Stimulation in Patients Diagnosed With Suboptimal Response
NCT ID: NCT03939390
Last Updated: 2022-04-06
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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COMPLETED
PHASE4
41 participants
INTERVENTIONAL
2020-01-17
2022-04-02
Brief Summary
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This is a controlled randomized clinical study.
We aim to include 41 patients diagnosed with suboptimal response who will undergo an ovarian stimulation in order to vitrify and accumulate oocytes.
The main variable for evaluating the efficacy in this exploratory study will be the number of oocyte cumulus complexes obtained.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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follicular phase stimulation
No interventions assigned to this group
luteal phase stimulation
time of administration of Corifollitropin Alfa
The treatment will be identical in both arms. The difference between the arms is the moment of the Administration of Corifollitropin Alfa: follicular phase of the menstrual cycle (control group) vs. luteal phase of the menstrual cycle (study group).
Interventions
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time of administration of Corifollitropin Alfa
The treatment will be identical in both arms. The difference between the arms is the moment of the Administration of Corifollitropin Alfa: follicular phase of the menstrual cycle (control group) vs. luteal phase of the menstrual cycle (study group).
Eligibility Criteria
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Inclusion Criteria
* Less than 10 oocytes obtained in a prior controlled protocol of conventional ovarian stimulation
* Age \< 41 years
* Body Mass Index (BMI) between 18 and 32 kg/m2
* Regular menstrual cycles between 21 and 35 days.
* Indication for in vitro fertilization
* Indication to start stimulation with 150mcg of corifollitropin alpha
* Presence of both ovaries
* Ability to participate and comply with study protocol
* Signing an informed consent form
Exclusion Criteria
* Endometriosis stage III/IV
* Patients with less than 4 oocytes in previous ovarian stimulation and poor ovarian reserve parameters (as per Bologna criteria)
* Concurrent participation in another study
18 Years
41 Years
FEMALE
No
Sponsors
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Instituto Bernabeu
OTHER
Responsible Party
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Jorge Sunol Sala
Dr
Locations
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Instituto Bernabeu
Alicante, , Spain
Countries
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References
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Sunol J, Castillo JC, Ortiz JA, Ten J, Fuentes A, Moliner B, Martinez M, Llacer J, Guerrero J, Pitas A, Bernabeu A, Bernabeu R. Conventional follicular-phase ovarian stimulation vs. luteal-phase stimulation in suboptimal responders: a randomized controlled trial. F S Rep. 2023 Jul 27;4(4):344-352. doi: 10.1016/j.xfre.2023.07.003. eCollection 2023 Dec.
Other Identifiers
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IB-0319-001
Identifier Type: -
Identifier Source: org_study_id
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