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

NCT02757287 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2018-09-05

No results posted yet for this study

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

Conditions

Interventions

DRUG

FSH-CTP + DESOGESTREL

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

Sponsors & Collaborators

  • Fundación Dexeus Salud de la Mujer

    collaborator UNKNOWN

  • Fundacion Dexeus

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2017-11-01
Completion
2018-12-01

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02757287 on ClinicalTrials.gov