Clinical Trials Directory

Trials / Completed

CompletedNCT03354494

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

Status
Completed
Phase
Study type
Observational
Enrollment
40 (actual)
Sponsor
Fundacion Dexeus · Academic / Other
Sex
Female
Age
18 Years – 35 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGDesogestrel (DSG) and Corifolitropin (FSH-CTP) Alfa

Timeline

Start date
2016-01-01
Primary completion
2017-06-01
Completion
2017-09-01
First posted
2017-11-28
Last updated
2017-11-28

Source: ClinicalTrials.gov record NCT03354494. Inclusion in this directory is not an endorsement.