Infertility Clinical Trial
Official title:
Usefulness of Medroxyprogesterone Acetate in Follicular Phase in Oocyte Donors.
Verified date | August 2021 |
Source | Instituto Valenciano de Infertilidad, IVI VALENCIA |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 318 |
Est. completion date | June 25, 2019 |
Est. primary completion date | June 25, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 35 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Spain | IVI Valencia | Valencia |
Lead Sponsor | Collaborator |
---|---|
Instituto Valenciano de Infertilidad, IVI VALENCIA |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 36 hours: from triggering until Oocyte retrieval |
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