Status:

COMPLETED

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

Lead Sponsor:

Instituto Valenciano de Infertilidad, IVI VALENCIA

Conditions:

Infertility

Eligibility:

FEMALE

18-35 years

Phase:

PHASE3

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 ot...

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 cos...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

October 20 2017

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 25 2019

Estimated Enrollment :

318 Patients enrolled

Trial Details

Trial ID

NCT03300960

Start Date

October 20 2017

End Date

June 25 2019

Last Update

August 25 2021

Active Locations (1)

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Page 1 of 1 (1 locations)

1

IVI Valencia

Valencia, Spain, 46015

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