Overview

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

Status:
Completed
Trial end date:
2019-06-25
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Instituto Valenciano de Infertilidad, IVI VALENCIA
Treatments:
Ganirelix
Medroxyprogesterone
Medroxyprogesterone Acetate
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:

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