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

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ClinicalTrials.gov Identifier: NCT03354494
Recruitment Status : Completed
First Posted : November 28, 2017
Last Update Posted : November 28, 2017
Sponsor:
Information provided by (Responsible Party):
Dr. Francisca Martínez, Institut Universitari Dexeus

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.


Condition or disease Intervention/treatment
Controlled Ovaria Stimulation Drug: Desogestrel (DSG) and Corifolitropin (FSH-CTP) Alfa

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Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Desogestrel (DSG) and Corifolitropin (FSH-CTP) Alfa for Ovarian Stimulation in Donors
Actual Study Start Date : January 2016
Actual Primary Completion Date : June 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Desogestrel

Group/Cohort Intervention/treatment
DSG-CTP Drug: Desogestrel (DSG) and Corifolitropin (FSH-CTP) Alfa



Primary Outcome Measures :
  1. 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

  2. Oocyte retrieved [ Time Frame: Oocyte retrieval day an average 10 days after beginning treatment ]
    Number of oocyte retrieved



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
- Population: donors (18-35 ) from candidates of Donor program
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.
Additional Information:
Publications:
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Responsible Party: Dr. Francisca Martínez, MD PhD, Institut Universitari Dexeus
ClinicalTrials.gov Identifier: NCT03354494    
Other Study ID Numbers: SMD-DSG-2017-15
First Posted: November 28, 2017    Key Record Dates
Last Update Posted: November 28, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Francisca Martínez, Institut Universitari Dexeus:
Oocyte donors
Ovarian stimulation
Desogestrel
Corifolitropina alfa
Gonadotropins
Additional relevant MeSH terms:
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Desogestrel
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists