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

Phase 4

• Conditions: Reproductive Techniques, Assisted
• Interventions: Drug: Recombinant follicle-stimulating hormone; Drug: Urinary follicle-stimulating hormone

• Registration Number: NCT02625519
• Lead Sponsor: Instituto Bernabeu

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.

Study Timeline

• Study First Submitted: 2015-11-09
• Study Start: 2015-12
• Study First Submitted QC: 2015-12-06
• Study First Posted: 2015-12-09
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-27
• Last Update Posted: 2018-08-28
• Primary Completion: 2019-01
• Study Completion: 2019-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 180

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Recombinant follicle-stimulating hormone	Recombinant follicle-stimulating hormone	Ovarian stimulation with recombinant follicle-stimulating hormone
Urinary follicle-stimulating hormone	Urinary follicle-stimulating hormone	Controled Ovarian stimulation with urinary follicle-stimulating hormone

Primary Outcome Measures

Name	Time	Method
number of cumulus-oocyte complexes obtained	through study completion, an average of 2 weeks	number of cumulus-oocyte complexes obtained by follicle puncture at the end of ovarian stimulation

Secondary Outcome Measures

Name	Time	Method
duration of stimulation (days)	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	through study completion, an average of 2 weeks	FSH treatment units administrated per oocyte obtained
FSH treatment cost per oocyte obtained	through study completion, an average of 2 weeks	FSH treatment cost per oocyte obtained
occurrence of side effects	through study completion, an average of 2 weeks	occurrence of side effects associated with urinary FSH and recombinant FSH
number of useful oocytes (inseminated or microinjected)	through study completion, an average of 2 weeks	number of useful oocytes after artificial insemination or microinjection
fertilization rate	through study completion, an average of 2 weeks	fertilization rate at 18 hours post-insemination
number of metaphase II (MII) oocytes	through study completion, an average of 2 weeks	number of metaphase II (MII) oocytes obtained by follicle puncture at the end of ovarian stimulation

Trial Locations

Locations (1)

Instituto Bernabeu; 🇪🇸 Alicante, Spain