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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03354494
Enrollment
40
Registered
2017-11-28
Start date
2016-01-31
Completion date
2017-09-30
Last updated
2017-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Controlled Ovaria Stimulation

Keywords

Oocyte donors, Ovarian stimulation, Desogestrel, Corifolitropina alfa, Gonadotropins

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.

Interventions

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

Sponsors

Fundacion Dexeus
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Total dose of gonadotrophinsAt the end of stimulation treatment period (from day of corifollitropin administration until the day of triggering) ) an average 10 days after beginning treatmentSum of gonadotrophins dose
Oocyte retrievedOocyte retrieval day an average 10 days after beginning treatmentNumber of oocyte retrieved

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026