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

August 27, 2018 updated by: Joaquín Llácer, Instituto Bernabeu

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

180

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Alicante, Spain, 03016
        • Recruiting
        • Instituto Bernabeu
        • Sub-Investigator:
          • Belén Lledó
        • Sub-Investigator:
          • Rafel Bernabeu
        • Sub-Investigator:
          • Jose Antonio Ortiz
        • Sub-Investigator:
          • Jaime Guerrero
        • Sub-Investigator:
          • Ruth Morales
        • Sub-Investigator:
          • Andrea Bernabeu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Urinary follicle-stimulating hormone
Controled Ovarian stimulation with urinary follicle-stimulating hormone
Drug: Urinary follicle-stimulating hormone
Ovarian stimulation with highly purified urinary follicle-stimulating hormone
Other Names:
  • urinary FSH
  • Fostipur®
EXPERIMENTAL: Recombinant follicle-stimulating hormone
Ovarian stimulation with recombinant follicle-stimulating hormone
Drug: Recombinant follicle-stimulating hormone
Controled ovarian stimulation with recombinant follicle-stimulating hormone
Other Names:
  • recombinant FSH
  • Bemfola®

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Bernabeu

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2015

Primary Completion (ANTICIPATED)

January 1, 2019

Study Completion (ANTICIPATED)

March 1, 2019

Study Registration Dates

First Submitted

November 9, 2015

First Submitted That Met QC Criteria

December 6, 2015

First Posted (ESTIMATE)

December 9, 2015

Study Record Updates

Last Update Posted (ACTUAL)

August 28, 2018

Last Update Submitted That Met QC Criteria

August 27, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BER-FSH-2015-01
  • 2015-003779-31 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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