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

Completed

• Conditions: Controlled Ovaria Stimulation
• Interventions: Drug: Desogestrel (DSG) and Corifolitropin (FSH-CTP) Alfa

• Registration Number: NCT03354494
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Primary Completion: 2017-06
• Study Completion: 2017-09
• Study First Submitted: 2017-09-28
• Status Verified: 2017-11
• Study First Submitted QC: 2017-11-24
• Last Update Submitted: 2017-11-24
• Study First Posted: 2017-11-28
• Last Update Posted: 2017-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
DSG-CTP	Desogestrel (DSG) and Corifolitropin (FSH-CTP) Alfa	-

Primary Outcome Measures

Name	Time	Method
Total dose of gonadotrophins	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	Oocyte retrieval day an average 10 days after beginning treatment	Number of oocyte retrieved