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

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ClinicalTrials.gov Identifier: NCT02625519
Recruitment Status : Unknown
Verified August 2018 by Joaquín Llácer, Instituto Bernabeu.
Recruitment status was:  Recruiting
First Posted : December 9, 2015
Last Update Posted : August 28, 2018
Sponsor:
Information provided by (Responsible Party):
Joaquín Llácer, 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.

Condition or disease Intervention/treatment Phase
Reproductive Techniques, Assisted Drug: Urinary follicle-stimulating hormone Drug: Recombinant follicle-stimulating hormone Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : December 2015
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine


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®




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. FSH treatment units obtained by oocyte [ Time Frame: through study completion, an average of 2 weeks ]
    FSH treatment units administrated per oocyte obtained

  5. FSH treatment cost per oocyte obtained [ Time Frame: through study completion, an average of 2 weeks ]
    FSH treatment cost per oocyte obtained

  6. fertilization rate [ Time Frame: through study completion, an average of 2 weeks ]
    fertilization rate at 18 hours post-insemination

  7. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02625519


Contacts
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Contact: Joaquín Llácer 965 154 000 jllacer@institutobernabeu.com

Locations
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Spain
Instituto Bernabeu Recruiting
Alicante, Spain, 03016
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         
Sponsors and Collaborators
Instituto Bernabeu
Investigators
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Principal Investigator: Joaquín Llácer Instituto Bernabeu
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Responsible Party: Joaquín Llácer, Gynaecologist. Reproductive Medicine Specialist at Institute Bernabeu, Instituto Bernabeu
ClinicalTrials.gov Identifier: NCT02625519    
Other Study ID Numbers: BER-FSH-2015-01
2015-003779-31 ( EudraCT Number )
First Posted: December 9, 2015    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: August 2018
Keywords provided by Joaquín Llácer, Instituto Bernabeu:
Controlled ovarian stimulation
Follicle-stimulating hormone
Receptor N680S follicle-stimulating hormone receptor (FSHR)
Gene polymorphism
Oocyte donors
Additional relevant MeSH terms:
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Hormones
Follicle Stimulating Hormone
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs