Efficacy of Urinary Vs Recombinant FSH in Oocyte Donors Based on Receptor N680S FSH Gene Polymorphism (Genodon Trial) (GENODON)
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|ClinicalTrials.gov Identifier: NCT02625519|
Recruitment Status : Unknown
Verified August 2018 by Joaquín Llácer, Instituto Bernabeu.
Recruitment status was: Recruiting
First Posted : December 9, 2015
Last Update Posted : August 28, 2018
|Condition or disease||Intervention/treatment||Phase|
|Reproductive Techniques, Assisted||Drug: Urinary follicle-stimulating hormone Drug: Recombinant follicle-stimulating hormone||Phase 4|
The aim of this study is to determine whether the number of oocytes obtained in women oocyte donors may be different with the use of rFSH or uFSH based on receptor N680S FSHR gene polymorphism.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||180 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official 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|
|Actual Study Start Date :||December 2015|
|Estimated Primary Completion Date :||January 2019|
|Estimated Study Completion Date :||March 2019|
Experimental: Urinary follicle-stimulating hormone
Controled Ovarian stimulation with urinary follicle-stimulating hormone
Drug: Urinary follicle-stimulating hormone
Ovarian stimulation with highly purified urinary follicle-stimulating hormone
Experimental: Recombinant follicle-stimulating hormone
Ovarian stimulation with recombinant follicle-stimulating hormone
Drug: Recombinant follicle-stimulating hormone
Controled ovarian stimulation with recombinant follicle-stimulating hormone
- number of cumulus-oocyte complexes obtained [ Time Frame: through study completion, an average of 2 weeks ]number of cumulus-oocyte complexes obtained by follicle puncture at the end of ovarian stimulation
- number of metaphase II (MII) oocytes [ Time Frame: through study completion, an average of 2 weeks ]number of metaphase II (MII) oocytes obtained by follicle puncture at the end of ovarian stimulation
- number of useful oocytes (inseminated or microinjected) [ Time Frame: through study completion, an average of 2 weeks ]number of useful oocytes after artificial insemination or microinjection
- duration of stimulation (days) [ Time Frame: through study completion, an average of 2 weeks ]mean number of days between the start of ovarian stimulation until the day of the follicular puncture
- FSH treatment units obtained by oocyte [ Time Frame: through study completion, an average of 2 weeks ]FSH treatment units administrated per oocyte obtained
- FSH treatment cost per oocyte obtained [ Time Frame: through study completion, an average of 2 weeks ]FSH treatment cost per oocyte obtained
- fertilization rate [ Time Frame: through study completion, an average of 2 weeks ]fertilization rate at 18 hours post-insemination
- occurrence of side effects [ Time Frame: through study completion, an average of 2 weeks ]occurrence of side effects associated with urinary FSH and recombinant FSH
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02625519
|Contact: Joaquín Llácer||965 154 email@example.com|
|Alicante, Spain, 03016|
|Sub-Investigator: Belén Lledó|
|Sub-Investigator: Rafel Bernabeu|
|Sub-Investigator: Jose Antonio Ortiz|
|Sub-Investigator: Jaime Guerrero|
|Sub-Investigator: Ruth Morales|
|Sub-Investigator: Andrea Bernabeu|
|Principal Investigator:||Joaquín Llácer||Instituto Bernabeu|