ClinicalTrials.gg
CompletedNCT03300960Updated Aug 25, 2021

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

A Phase 3 interventional study of Provera 10 mg. and Ganirelix (GnRH antagonist) in Infertility, sponsored by Instituto Valenciano de Infertilidad, IVI VALENCIA. Completed at 1 site in Spain. Open to female participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-08-25.

Sponsored by Instituto Valenciano de Infertilidad, IVI VALENCIA · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
318
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 18 studies in Infertility by Instituto Valenciano de Infertilidad, IVI VALENCIA — 3 open to participants now, 3 under way, none of them phase 3. Infertility · Instituto Valenciano de Infertilidad, IVI VALENCIA.

Enrollment
6th of 16
318 · median 192
Started
2017
the only one that year
Phase 3
2 of 18
none open now
Registered
13th of 18
by date

Among the 18 studies in Infertility by Instituto Valenciano de Infertilidad, IVI VALENCIA, this one is the 6th largest by enrollment of the 16 interventional ones, is the only one that started in 2017, is one of 2 in phase 3, and was the 13th registered.

By phase

18 studies; the count open now beside each. This study's row is marked.

No phase10 · 2 open
Phase 44 · 0 open
Observational2 · 1 open
Phase 3this study2 · 0 open

By the year they started

First in 2007; this study’s year is marked. 1 started in 2017.

Size and results

Median enrollment 192 across the 16 interventional studies, 114 across the 2 observational. Of the 13 that completed or were terminated, 1 (8%) have results posted.

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02

Study 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.

Read the 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.

03

Conditions studied

  • Infertility

Browse trials for

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
  • : 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 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 ( Virus; Virus, VIH Virus Syphilis)
    6. Results within range of general analysis of hemogram, hemostasia y biochemistry.

Exclusion criteria

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 Virus; Virus or VIH Virus
  • Known to PMA or its
  • 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
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
318 participants (actual)

Study arms

  • Experimental
    Provera

    Drug: Provera 10 mg.

  • Active comparator
    Orgalutrán Ganirelix (GnRH antagonist)

    Drug: Ganirelix (GnRH antagonist)

Interventions

  • 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.

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

06

What researchers measure

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.

    Time frame: 36 hours: from triggering until Oocyte retrieval

07

Study locations

1 site
  • IVI Valencia
    Valencia, 46015, Spain
08

References and documents

Publications

  • 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. PubMed 33814126 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2017 to primary completion in Jun 2019, 20 months.

Of 59 phase 3 interventional studies under Infertility, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 47. This study's 20 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 26, 2017
First posted
Oct 4, 2017
StartActual
Oct 20, 2017
Primary completionActual
Jun 25, 2019
CompletionActual
Jun 25, 2019
Last update
Aug 25, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 25, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03300960
Lead sponsor
Instituto Valenciano de Infertilidad, IVI VALENCIA
Responsible party
Sponsor
First posted
Oct 4, 2017
Start date
Oct 20, 2017
Primary completion
Jun 25, 2019
Completion
Jun 25, 2019
Last update
Aug 25, 2021

Study contacts

Juan Giles, MD PhD
principal investigator · Gynecologist IVI Valencia

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Medroxyprogesterone Acetate

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