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

Instituto Bernabeu

Status and phase: Unknown; Phase 4

Conditions: Reproductive Techniques, Assisted

Treatments: Drug: Recombinant follicle-stimulating hormone; Drug: Urinary follicle-stimulating hormone

Study type: Interventional

Funder types: Other

Identifiers

NCT02625519

BER-FSH-2015-01

2015-003779-31 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 estimated patients

Sex: Female

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 2 patient groups

Urinary follicle-stimulating hormone

Experimental group

Description:

Controled Ovarian stimulation with urinary follicle-stimulating hormone

Treatment:

Drug: Urinary follicle-stimulating hormone

Recombinant follicle-stimulating hormone

Experimental group

Description:

Ovarian stimulation with recombinant follicle-stimulating hormone

Treatment:

Drug: Recombinant follicle-stimulating hormone