Usefulness of Medroxyprogesterone Acetate in Follicular Phase in Oocyte Donors. Undergoing Ovarian Stimulation

August 24, 2021 updated by: Instituto Valenciano de Infertilidad, IVI VALENCIA

Usefulness of Medroxyprogesterone Acetate in Follicular Phase in Oocyte Donors.

The purpose of this study is to determine whether Medroxyprogesterone Acetate (MPA) administration in follicular phase prevents premature luteinization with equal efficiency as GnRH antagonists and otains similar clinical results in oocyte donation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Within the new guidelines for stimulation, the use of oral progesterone in follicular phase allows GnRH analogue administration, resulting in greater comfort for patients as well as a reduction in cost. Obtained results are similar to those from conventional protocols in terms of: early luteinization, number of oocytes, embryos number and rate of implantation and gestation or appearance of congenital malformations. Another advantage is the lower incidence of OHSS (Ovarian Hyperstimulation Syndrome).

From a scientific point of view, it would allow a better understanding of folliculogenesis, of progesterone mechanism of action on blocking LH secretion and its effect on ovarian and later embryonic level.

From a clinical point of view, it would simplify COS (Controlled Ovarian Stimulation) by reducing the number of medication administered subcutaneously and their possible side effects on both systemic and local levels. It would be of special interest in 2 groups of patients, for example, oocyte donors and patients undergoing preservation of fertility. To date, there is a lack of studies along these lines.

Study Type

Interventional

Enrollment (Actual)

318

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Valencia, Spain, 46015
        • IVI Valencia

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

16 years to 33 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Age between 18-35 years (both included)
  • Regular Menses (between 25-35 days)
  • Absence of physical and psychic pathologies at the time of oocyte donation
  • BMI: 18-28 kg(m2 at the time of oocyte donation.

  • Other criteria to comply with:

    i. With no relevant personal or family medical history ii. Signing of Informed Consent iii. From a medical point of view:

    1. Healthy ovaries and uterus, with no organic pathology
    2. Ovaries without polycystic aspect
    3. Antral Follicle Count > 12 in the sum of both ovaries
    4. Normal Karyotype
    5. Negative results in infectious illness screening (Hepatitis B Virus; Hepatitis C Virus, VIH Virus Syphilis)

    6. Results within range of general analysis of hemogram, hemostasia y biochemistry.

      Exclusion Criteria:

  • Any systemic or metabolic disorder which contraindicate the use of Gonadotrophines
  • Medical background of Trombophlebitis or thromboembolic phenomena or Arterial Hypertension
  • Severe hepatic insufficiency, cardiovascular illness
  • Suspicion or evidence of malignity of mamarian glands or other hormone dependant genital organs
  • Known infection of Hepatitis B Virus; Hepatitis C Virus or VIH Virus
  • Known hypersensitivity to PMA or its excipients
  • Any reason or cause which excluede from the oocyte donation program
  • Participation in another clinical trial in the two months prior to the inclusion on this study

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

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Provera
Drug: Provera 10 mg.
One 10 mg tablet of MPA (Medroxyprogesterone acetate) is administered every 24 hours from the onset of Controlled Ovarian Stimulation (COS), until the day of triggering.
Active Comparator: Orgalutrán Ganirelix (GnRH antagonist)
Drug: Ganirelix (GnRH antagonist)
One ampoule of Ganirelix (GnRH antagonist) a day once diameter of follicles are 14 mm diameter on average until triggering.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare number of oocytes using GnRH antagonist versus PMA.
Time Frame: 36 hours: from triggering until Oocyte retrieval
Compare oocytes in COS cycles between two groups: using GnRH antagonist versus PMA for avoiding premature luteinization.
36 hours: from triggering until Oocyte retrieval

Collaborators and Investigators

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

Sponsor

Instituto Valenciano de Infertilidad, IVI VALENCIA

Investigators

  • Principal Investigator: Juan Giles, MD PhD, Gynecologist IVI Valencia

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

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)

October 20, 2017

Primary Completion (Actual)

June 25, 2019

Study Completion (Actual)

June 25, 2019

Study Registration Dates

First Submitted

September 26, 2017

First Submitted That Met QC Criteria

September 28, 2017

First Posted (Actual)

October 4, 2017

Study Record Updates

Last Update Posted (Actual)

August 25, 2021

Last Update Submitted That Met QC Criteria

August 24, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1705-VLC-030-JG

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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.

Clinical Trials on Infertility

Clinical Trials on Provera 10 mg.

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Congo, DR of

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe