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

November 24, 2017 updated by: Dr. Francisca Martínez, Institut Universitari Dexeus

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

40

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

- Population: donors (18-35 ) from candidates of Donor program

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
DSG-CTP
Drug: Desogestrel (DSG) and Corifolitropin (FSH-CTP) Alfa

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total dose of gonadotrophins
Time Frame: 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
At the end of stimulation treatment period (from day of corifollitropin administration until the day of triggering) ) an average 10 days after beginning treatment
Oocyte retrieved
Time Frame: Oocyte retrieval day an average 10 days after beginning treatment
Number of oocyte retrieved
Oocyte retrieval day an average 10 days after beginning treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Universitari Dexeus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

September 28, 2017

First Submitted That Met QC Criteria

November 24, 2017

First Posted (Actual)

November 28, 2017

Study Record Updates

Last Update Posted (Actual)

November 28, 2017

Last Update Submitted That Met QC Criteria

November 24, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMD-DSG-2017-15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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