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Clinical Trials/NCT03354494
NCT03354494
Completed
Not Applicable

Desogestrel (DSG) and Corifolitropin (FSH-CTP) Alfa for Ovarian Stimulation in Donors

Institut Universitari Dexeus0 sites40 target enrollmentJanuary 2016

Overview

Phase
Not Applicable
Intervention
Desogestrel (DSG) and Corifolitropin (FSH-CTP) Alfa
Conditions
Controlled Ovaria Stimulation
Sponsor
Institut Universitari Dexeus
Enrollment
40
Primary Endpoint
Total dose of gonadotrophins
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

Currently, controlled ovarian stimulation (COS) in oocyte donors is performed by daily injections of gonadotropins( recombinant FSH) plus a GnRH Antagonist usually form 5th-6th stimulation day until ovulation induction with a bolus of another injection of a gonadotropin-releasing hormone (GnRH) Agonist. Injections of the GnRH Antagonist avoid untimely luteinizing hormone (LH) surge and spontaneous ovulation prior to follicular aspiration. There is a preparation of long-acting recombinant follicle stimulating hormone (rFSH= (corifollitropin alfa (FSH-CTP), Elonva®, MSD), that allows that a single subcutaneous injection substitutes the first 7 days of daily gonadotropin injections. On the other hand, a contraceptive oral progesterone only( Desogestrel, DSG) is available for contraception, avoiding the LH surge.

In donors, by administering a single injection of FSH-CTP and oral desogestrel since the first menstruation day, the total number of injections administered is reduced and less discomfort is experienced without adverse impact on ovarian response.

Other authors have reported good results using similar synthetic progestins (Medroxyprogesterone, dihydrogesterone, and natural progesterone).

No description of the hormonal and ovarian response under this protocol has been published. Direct comparison between this novel protocol and the classical GnRH- antagonist plus daily gonadotropins has not been reported.

Registry
clinicaltrials.gov
Start Date
January 2016
End Date
September 2017
Last Updated
8 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Institut Universitari Dexeus
Responsible Party
Principal Investigator
Principal Investigator

Dr. Francisca Martínez

MD PhD

Institut Universitari Dexeus

Eligibility Criteria

Inclusion Criteria

  • Fulfilling inclusión medical and legal criteria (RD - Spanish law adapting european rule-9/2014)
  • Who had had undergone previously convencional COS (controlled ovarian stimulation) with FSH-CTP and daily antagonist injections
  • Given signed consent form.

Exclusion Criteria

  • Previous low response to COS
  • Previous ovarian hyperstimulation syndrome.
  • Ovarian cysts.

Arms & Interventions

DSG-CTP

Intervention: Desogestrel (DSG) and Corifolitropin (FSH-CTP) Alfa

Outcomes

Primary Outcomes

Total dose of gonadotrophins

Time Frame: At the end of stimulation treatment period (from day of corifollitropin administration until the day of triggering) ) an average 10 days after beginning treatment

Sum of gonadotrophins dose

Oocyte retrieved

Time Frame: Oocyte retrieval day an average 10 days after beginning treatment

Number of oocyte retrieved

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