NCT03300960

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
318

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 26, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 4, 2017

Completed
16 days until next milestone

Study Start

First participant enrolled

October 20, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2019

Completed
Last Updated

August 25, 2021

Status Verified

August 1, 2021

Enrollment Period

1.7 years

First QC Date

September 26, 2017

Last Update Submit

August 24, 2021

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Provera

EXPERIMENTAL
Drug: Provera 10 mg.

Orgalutrán Ganirelix (GnRH antagonist)

ACTIVE COMPARATOR
Drug: Ganirelix (GnRH antagonist)

Interventions

Provera 10 mg.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.

Provera
Ganirelix (GnRH antagonist)DRUG

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

Orgalutrán Ganirelix (GnRH antagonist)

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IVI Valencia

Valencia, 46015, Spain

Location

Related Publications (1)

  • 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.

    PMID: 33814126DERIVED

MeSH Terms

Conditions

Infertility

Interventions

Medroxyprogesterone Acetateganirelix

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

MedroxyprogesteroneHydroxyprogesteronesProgesteronePregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Juan Giles, MD PhD

    Gynecologist IVI Valencia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2017

First Posted

October 4, 2017

Study Start

October 20, 2017

Primary Completion

June 25, 2019

Study Completion

June 25, 2019

Last Updated

August 25, 2021

Record last verified: 2021-08

Locations

ES(1)