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

Primary Purpose

Infertility

Status
Completed
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Provera 10 mg.
Ganirelix (GnRH antagonist)
Sponsored by
Instituto Valenciano de Infertilidad, IVI VALENCIA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Infertility

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • IVI Valencia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Provera

Orgalutrán Ganirelix (GnRH antagonist)

Arm Description

Outcomes

Primary Outcome Measures

Compare number of oocytes using GnRH antagonist versus PMA.
Compare oocytes in COS cycles between two groups: using GnRH antagonist versus PMA for avoiding premature luteinization.

Secondary Outcome Measures

Full Information

First Posted
September 26, 2017
Last Updated
August 24, 2021
Sponsor
Instituto Valenciano de Infertilidad, IVI VALENCIA
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1. Study Identification

Unique Protocol Identification Number
NCT03300960
Brief Title
Usefulness of Medroxyprogesterone Acetate in Follicular Phase in Oocyte Donors. Undergoing Ovarian Stimulation
Official Title
Usefulness of Medroxyprogesterone Acetate in Follicular Phase in Oocyte Donors.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
October 20, 2017 (Actual)
Primary Completion Date
June 25, 2019 (Actual)
Study Completion Date
June 25, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto Valenciano de Infertilidad, IVI VALENCIA

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
318 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Provera
Arm Type
Experimental
Arm Title
Orgalutrán Ganirelix (GnRH antagonist)
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Provera 10 mg.
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Ganirelix (GnRH antagonist)
Intervention Description
One ampoule of Ganirelix (GnRH antagonist) a day once diameter of follicles are 14 mm diameter on average until triggering.
Primary Outcome Measure Information:
Title
Compare number of oocytes using GnRH antagonist versus PMA.
Description
Compare oocytes in COS cycles between two groups: using GnRH antagonist versus PMA for avoiding premature luteinization.
Time Frame
36 hours: from triggering until Oocyte retrieval

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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: Healthy ovaries and uterus, with no organic pathology Ovaries without polycystic aspect Antral Follicle Count > 12 in the sum of both ovaries Normal Karyotype Negative results in infectious illness screening (Hepatitis B Virus; Hepatitis C Virus, VIH Virus Syphilis) 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan Giles, MD PhD
Organizational Affiliation
Gynecologist IVI Valencia
Official's Role
Principal Investigator
Facility Information:
Facility Name
IVI Valencia
City
Valencia
ZIP/Postal Code
46015
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33814126
Citation
Giles J, Alama P, Gamiz P, Vidal C, Badia P, Pellicer A, Bosch E. Medroxyprogesterone acetate is a useful alternative to a gonadotropin-releasing hormone antagonist in oocyte donation: a randomized, controlled trial. Fertil Steril. 2021 Aug;116(2):404-412. doi: 10.1016/j.fertnstert.2021.02.036. Epub 2021 Apr 2.
Results Reference
derived

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

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