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

Phase 4

Withdrawn

• Conditions: Infertility
• Interventions: Drug: FSH-CTP + DESOGESTREL

• Registration Number: NCT02757287
• 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. It has been described the usefulness of orally administered medroxyprogesterone acetate, 10 mg to inhibit the endogenous LH surge in IVF patients during COS.

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. No description of the hormonal and ovarian response under this protocol has been published

Detailed Description

* oral desogestrel since the first menstruation day,

* a single injection of FSH-CTP on the 7th menstrual cycle day

* routine monitoring of ovarian response with transvaginal ultrasound every second day until pre-ovulatory bolus of GnRH

* Hormones measured on day of 7th menstrual cycle day , day of pre-ovulatory bolus of GnRH and the day after the bolus ( estradiol, FSH, Progesterone, LH)

* Quality of Life questionnaire the day after the bolus

Study Timeline

• Study First Submitted: 2016-04-25
• Study First Submitted QC: 2016-04-29
• Study Start: 2016-05
• Study First Posted: 2016-05-02
• Primary Completion: 2017-11-01
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-03
• Last Update Posted: 2018-09-05
• Study Completion: 2018-12-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

• Population: donors (18-35 ) from candidates of Donor program
• Fulfilling inclusión medical and legal criteria (RD -Ley de transposición de la normativa europea a la legislación española 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: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FSH-CTP + DESOGESTREL	FSH-CTP + DESOGESTREL	Single injection of FSH-CTP and oral desogestrel since the first menstruation day, until bolus of GnRH agonist to follicular maturation

Primary Outcome Measures

Name	Time	Method
Total dose of gonadotrophins	At the end of the stimulation treatment period (5 or 7 days after begining of treatment)	Total Consume of gonadotrophins

Secondary Outcome Measures

Name	Time	Method
Number of mature oocytes	Day of oocyte recovery
Plasma LH	Day of GnrH bolus	Level of LH in plasma (mIU/ml)

Trial Locations

Locations (1)

Hospital Quiron Dexeus; 🇪🇸 Barcelona, Spain