InfertilityPhase 4NCT02796105
Progevera 10 mg® Versus Orgalutran® in Ovarian Stimulation Cycles of Oocyte Donors
A Phase 4 study testing Progevera and Orgalutran in people with Infertility, run by Fundació Privada Eugin at 1 site in Spain.
Trial summary
Evaluation of efficacy and safety of medroxiprogesterone acetate (Progevera 10 mg®) versus GnRh antagonist (Orgalutran®) in ovarian stimulation cycles of oocyte donors Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Progevera and Orgalutran
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 232 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2016to 10 Jul 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Oocyte donors included in the oocyte donation program of Clinica EUGIN.
- 1st oocyte donation cycle at Clínica EUGIN.
Who cannot join
- Polycistic Ovarian syndrome (PCOs).
- Estradiol levels on day 2 of menstrual cycle >70 pg/ml.
- Hormone treatments up to 3 months before the oocyte donation cycle.
- Medical contraindication to the treatments used in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Efficacy and Safety of Medroxiprogesterone Acetate (Progevera 10 mg®) Versus GnRh Antagonist (Orgalutran®) in Ovarian Stimulation Cycles of Oocyte Donors
Evaluation of efficacy and safety of medroxiprogesterone acetate (Progevera 10 mg®) versus GnRh antagonist (Orgalutran®) in ovarian stimulation cycles of oocyte donors
- Conditions
- Infertility
- Being tested
- Progevera, Orgalutran
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProgeveraDrug
OrgalutranDrug
| Study group | Role | What they receive |
|---|---|---|
| Progevera | Experimental | Progevera 10 mg Receives: Drug: Progevera |
| Orgalutran | Active comparator | Orgalutran 0.25 mg Receives: Drug: Orgalutran |
What is being measured
The primary outcome is the main question the study is designed to answer.
donor ovarian response
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionJul 2017
- Study completion10 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 232 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundació Privada Eugin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rebeca Begueria, Dr, Principal investigator, Clinica Eugin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02796105
- Sponsor's protocol ID
- BRAKE
- Status last verified
- Sep 2017
- First submitted
- 7 Jun 2016
- Last updated
- 13 Sep 2017
- Results posted
- No
Publications
Begueria R, Garcia D, Vassena R, Rodriguez A. Medroxyprogesterone acetate versus ganirelix in oocyte donation: a randomized controlled trial. Hum Reprod. 2019 May 1;34(5):872-880. doi: 10.1093/humrep/dez034.
PubMed 30927417
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Efficacy and Safety of Medroxiprogesterone Acetate (Progevera 10 mg®) Versus GnRh Antagonist (Orgalutran®) in Ovarian Stimulation Cycles of Oocyte Donors
- ClinicalTrials.gov ID
- NCT02796105
- Acronym / sponsor ID
- BRAKE
- Conditions
- Infertility
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 232 participants (actual)
- Lead sponsor
- Fundació Privada EuginUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- 10 Jul 2017 (actual)
- First posted
- 10 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of efficacy and safety of medroxiprogesterone acetate (Progevera 10 mg®) versus GnRh antagonist (Orgalutran®) in ovarian stimulation cycles of oocyte donors
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Progevera | Experimental | Drug: ProgeveraProgevera 10 mg |
| Orgalutran | Active comparator | Drug: OrgalutranOrgalutran 0.25 mg |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Oocyte donors included in the oocyte donation program of Clinica EUGIN.
- 1st oocyte donation cycle at Clínica EUGIN.
Key exclusion criteria (4 listed)
- Polycistic Ovarian syndrome (PCOs).
- Estradiol levels on day 2 of menstrual cycle >70 pg/ml.
- Hormone treatments up to 3 months before the oocyte donation cycle.
- Medical contraindication to the treatments used in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Progevera | Drug | Progevera |
| Orgalutran | Drug | Orgalutran |
Primary outcome
donor ovarian response
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2017.
- Derived from this study: PubMed 30927417Begueria R, Garcia D, Vassena R, Rodriguez A. Medroxyprogesterone acetate versus ganirelix in oocyte donation: a randomized controlled trial. Hum Reprod. 2019 May 1;34(5):872-880. doi: 10.1093/humrep/dez034.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebeca Begueria, Dr principal investigator
Clinica Eugin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Progevera and Orgalutran in people with Infertility, run by Fundació Privada Eugin at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
donor ovarian response (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02796105, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2017.