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

Reproductive Techniques, Assisted Clinical Trial

— GENODON  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02625519
• Other study ID #: BER-FSH-2015-01
• Secondary ID: 2015-003779-31
• Status: Recruiting
• Phase: Phase 4
• Start date: December 2015
• Est. completion date: March 2019

Study information

• Verified date: August 2018
• Source: Instituto Bernabeu
• Contact: Joaquín Llácer
• Phone: 965 154 000
• Email: jllacer[@]institutobernabeu.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: March 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Reproductive Techniques, Assisted

Intervention

Drug:
• Urinary follicle-stimulating hormone
Ovarian stimulation with highly purified urinary follicle-stimulating hormone
• Recombinant follicle-stimulating hormone
Controled ovarian stimulation with recombinant follicle-stimulating hormone

Locations

Country	Name	City	State
Spain	Instituto Bernabeu	Alicante

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Bernabeu

Country where clinical trial is conducted

Spain, 

Outcome

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