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Trial · Interventional

CompletedPhase 3Registry data

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

NCTNCT03300960 (opens ClinicalTrials.gov in a new tab)Other id1705-VLC-030-JG
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
318 participants (actual)
Sponsor
Instituto Valenciano de Infertilidad, IVI VALENCIA · Other
Design
Randomized · Open label (no masking)
Countries
1 country

Spain

Start
20 Oct 2017
Primary completion
25 Jun 2019
Completion
25 Jun 2019
First posted
4 Oct 2017
Last update posted
25 Aug 2021
Conditions
Infertility

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2017201820192020
  1. Ph 3

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

    NCT03300960

    20 Oct 2017 to 25 Jun 2019

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Provera 10 mg.Drug
  • Ganirelix (GnRH antagonist)Drug

Arms2

  • Experimental

    Provera

  • Active comparator

    Orgalutrán Ganirelix (GnRH antagonist)

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Compare number of oocytes using GnRH antagonist versus PMA.

    Time frame · 36 hours: from triggering until Oocyte retrieval

    Registry description

    Compare oocytes in COS cycles between two groups: using GnRH antagonist versus PMA for avoiding premature luteinization.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2021

8 results

Medroxyprogesterone acetate is a useful alternative to a gonadotropin-releasing hormone antagonist in oocyte donation: a randomized, controlled trial.

Giles et al. 2021Fertility and sterilitycited by 52

PMID 33814126DOI 10.1016/j.fertnstert.2021.02.036PUB-33814126

Full text at the publisher8 results
Publisher pageSee results (8)

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years up to 35 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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

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