Efficacy of Urinary Vs Recombinant FSH in Oocyte Donors Based on Receptor N680S FSH Gene Polymorphism (Genodon Trial)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Reproductive Techniques, Assisted

Intervention / Treatment
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* Drug: Urinary follicle-stimulating hormone
* Drug: Recombinant follicle-stimulating hormone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Urinary follicle-stimulating hormone<br>Controled Ovarian stimulation with urinary follicle-stimulating hormone | Drug: Urinary follicle-stimulating hormone<br>* Ovarian stimulation with highly purified urinary follicle-stimulating hormone<br>* Other names: Fostipur®;|
| Experimental: Recombinant follicle-stimulating hormone<br>Ovarian stimulation with recombinant follicle-stimulating hormone | Drug: Recombinant follicle-stimulating hormone<br>* Controled ovarian stimulation with recombinant follicle-stimulating hormone<br>* Other names: Bemfola®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| number of useful oocytes (inseminated or microinjected) | number of useful oocytes after artificial insemination or microinjection | through study completion, an average of 2 weeks | 
| 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 | 
| FSH treatment units obtained by oocyte | FSH treatment units administrated per oocyte obtained | through study completion, an average of 2 weeks | 
| FSH treatment cost per oocyte obtained | FSH treatment cost per oocyte obtained | through study completion, an average of 2 weeks | 
| fertilization rate | fertilization rate at 18 hours post-insemination | through study completion, an average of 2 weeks | 
| occurrence of side effects | occurrence of side effects associated with urinary FSH and recombinant FSH | through study completion, an average of 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Controlled ovarian stimulation, Follicle-stimulating hormone, Receptor N680S follicle-stimulating hormone receptor (FSHR), Gene polymorphism, Oocyte donors