Efficacy of Urinary Vs Recombinant FSH in Oocyte Donors Based on Receptor N680S FSH Gene Polymorphism (Genodon Trial)
NCT ID: NCT02625519
Last Updated: 2018-08-28
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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UNKNOWN
PHASE4
180 participants
INTERVENTIONAL
2015-12-31
2019-03-31
Brief Summary
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Detailed Description
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This is an exploratory, prospective, randomized, comparative, open trial with control group treated according to the usual therapeutic approach in our institution for ovarian stimulation for oocyte donors prospective exploratory study control group .
Three groups will be set based on follicle-stimulating hormone receptor (FSHR) genotype for the polymorphism N680: Group SS (Ser/Ser), group SN (Ser/Asn) and group NN (Asn/Asn). Donor members of each group will be randomly assigned to receive daily 225 IU of recombinant or urinary FSH for controlled ovarian stimulation protocol with antagonists. To avoid unintentional bias, allocation to treatment group will take place at the time in which ovarian stimulation according begins with a list of random allocation of treatments for each of the groups (SS , SN and NN) that will be associated the code of the patient and are prepared and will be available before the start of the study. The code assignment and treatment of the patient will consecutively in the order of the list and must be recorded in the medical history of the patient. The next scheduled patient will be assigned to the code and the next immediate treatment in this list.
The protocol for controlled ovarian stimulation in oocyte donors, will be performed always according to the usual protocol in the Instituto Bernabeu.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Urinary follicle-stimulating hormone
Controled Ovarian stimulation with urinary follicle-stimulating hormone
Urinary follicle-stimulating hormone
Ovarian stimulation with highly purified urinary follicle-stimulating hormone
Recombinant follicle-stimulating hormone
Ovarian stimulation with recombinant follicle-stimulating hormone
Recombinant follicle-stimulating hormone
Controled ovarian stimulation with recombinant follicle-stimulating hormone
Interventions
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Urinary follicle-stimulating hormone
Ovarian stimulation with highly purified urinary follicle-stimulating hormone
Recombinant follicle-stimulating hormone
Controled ovarian stimulation with recombinant follicle-stimulating hormone
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age between 18 and 30 years
* Body Mass Index over 18 and under 28
* Antral follicle count greater than 9 and less than 25 (adding both ovaries)
* Patients starting ovarian stimulation with 225 IU of FSH
* Presence of both ovaries
* Ability to participate and comply with the study protocol
* Signing the written consent form
* Not having received treatment with ovulation stimulators in the 3 months prior to stimulation
Exclusion Criteria
* Concurrent participation in another study
18 Years
30 Years
FEMALE
Yes
Sponsors
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Instituto Bernabeu
OTHER
Responsible Party
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Joaquín Llácer
Gynaecologist. Reproductive Medicine Specialist at Institute Bernabeu
Principal Investigators
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Joaquín Llácer
Role: PRINCIPAL_INVESTIGATOR
Instituto Bernabeu
Locations
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Instituto Bernabeu
Alicante, , Spain
Countries
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Central Contacts
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Other Identifiers
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2015-003779-31
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
BER-FSH-2015-01
Identifier Type: -
Identifier Source: org_study_id
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