Clinical trial NCT02625519: Efficacy of Urinary Vs Recombinant FSH in Oocyte Donors Based on Receptor N680S FSH Gene Polymorphism (Genodon Trial)
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Reproductive Techniques, Assisted
Keywords: Controlled ovarian stimulation
Follicle-stimulating hormone
Receptor N680S follicle-stimulating hormone receptor (FSHR)
Gene polymorphism
Oocyte donors
Lead sponsor: Instituto Bernabeu
Sponsor class: OTHER
First posted: 2015-12-09
Enrollment: 180
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: number of cumulus-oocyte complexes obtained
timeFrame: through study completion, an average of 2 weeks
Secondary outcomes:
measure: number of metaphase II (MII) oocytes
timeFrame: through study completion, an average of 2 weeks
measure: number of useful oocytes (inseminated or microinjected)
timeFrame: through study completion, an average of 2 weeks
measure: duration of stimulation (days)
timeFrame: through study completion, an average of 2 weeks
measure: FSH treatment units obtained by oocyte
timeFrame: through study completion, an average of 2 weeks
measure: FSH treatment cost per oocyte obtained
timeFrame: through study completion, an average of 2 weeks
measure: fertilization rate
timeFrame: through study completion, an average of 2 weeks
measure: occurrence of side effects
timeFrame: through study completion, an average of 2 weeks
Other outcomes:
Locations:
city: Alicante
country: Spain
facility: Instituto Bernabeu
Study officials:
affiliation: Instituto Bernabeu
name: Joaquín Llácer
role: PRINCIPAL_INVESTIGATOR
References: