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

NCT ID: NCT03300960

Last Updated: 2021-08-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 318 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-20
• Study Completion Date: 2019-06-25

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.

Conditions

Infertility

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Provera

Group Type: EXPERIMENTAL

Provera 10 mg.

Intervention Type: DRUG

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.

Orgalutrán Ganirelix (GnRH antagonist)

Group Type: ACTIVE_COMPARATOR

Ganirelix (GnRH antagonist)

Intervention Type: DRUG

One ampoule of Ganirelix (GnRH antagonist) a day once diameter of follicles are 14 mm diameter on average until triggering.

Interventions

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.

Intervention Type: DRUG

Ganirelix (GnRH antagonist)

One ampoule of Ganirelix (GnRH antagonist) a day once diameter of follicles are 14 mm diameter on average until triggering.

Intervention Type: DRUG

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:

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Instituto Valenciano de Infertilidad, IVI VALENCIA

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Juan Giles, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Gynecologist IVI Valencia

Locations

IVI Valencia

Valencia, , Spain

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 33814126 (View on PubMed)

Other Identifiers

1705-VLC-030-JG

Identifier Type: -

Identifier Source: org_study_id