Reproductive Techniques, Assisted Clinical Trial
— GENODONOfficial title:
Prospective, Randomized Open Trial to Evaluate the Efficacy of Highly Purified Urinary FSH Versus Recombinant FSH in Oocyte Donors Undergoing Controlled Ovarian Stimulation Based on Receptor N680S FSH Gene Polymorphism. Genodon Trial
Exploratory, prospective, randomized, comparative, open trial with control group treated to assess whether the effective use of urinary FSH (uFSH) or recombinant FSH (rFSH) can be influenced by genotype of receptor N680S FSH Gene Polymorphism.
Status | Recruiting |
Enrollment | 180 |
Est. completion date | March 2019 |
Est. primary completion date | January 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 30 Years |
Eligibility |
Inclusion Criteria: - Be considered eligible to get into the oocyte donation program of Instituto Bernabeu - 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: - Not suitable for inclusion in the oocyte donation program of Institute Bernabeu - Concurrent participation in another study |
Country | Name | City | State |
---|---|---|---|
Spain | Instituto Bernabeu | Alicante |
Lead Sponsor | Collaborator |
---|---|
Instituto Bernabeu |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | number of cumulus-oocyte complexes obtained | number of cumulus-oocyte complexes obtained by follicle puncture at the end of ovarian stimulation | through study completion, an average of 2 weeks | |
Secondary | number of metaphase II (MII) oocytes | number of metaphase II (MII) oocytes obtained by follicle puncture at the end of ovarian stimulation | through study completion, an average of 2 weeks | |
Secondary | number of useful oocytes (inseminated or microinjected) | number of useful oocytes after artificial insemination or microinjection | through study completion, an average of 2 weeks | |
Secondary | duration of stimulation (days) | mean number of days between the start of ovarian stimulation until the day of the follicular puncture | through study completion, an average of 2 weeks | |
Secondary | FSH treatment units obtained by oocyte | FSH treatment units administrated per oocyte obtained | through study completion, an average of 2 weeks | |
Secondary | FSH treatment cost per oocyte obtained | FSH treatment cost per oocyte obtained | through study completion, an average of 2 weeks | |
Secondary | fertilization rate | fertilization rate at 18 hours post-insemination | through study completion, an average of 2 weeks | |
Secondary | occurrence of side effects | occurrence of side effects associated with urinary FSH and recombinant FSH | through study completion, an average of 2 weeks |
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