SterilityPROMENIANCT01331733
Comparative Assessment of the Clinical Utility of Ovarian Stimulation With Menotropin Versus Menotropin Plus GnRH Antagonist
An observational study of Sterility, run by Ferring Pharmaceuticals at 7 sites in Spain.
Trial summary
To assess the effectiveness of protocols of ovarian hyperstimulation combining urinary gonadotrophins + GnRH antagonist vs urinary gonadotrophins, to achieve clinical pregnancy in females undergoing intrauterine insemination. Read more about this study
- Who is it for?
- Ages 18 to 36 years, women only
- Conditions the study is for
- Sterility
- What is being tested?
- hMG-HP and hMG + GnRH antagonist
- How many people
- 131 participants
- Where
- 7 sitesSpain
- Study dates
- Nov 2006to Mar 2009
- Phase
- Observational
- 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 36 years
- Women only
- No healthy volunteers
- Adult
Study population: Females affected by sterility able to undergo intrauterine insemination
Who may be able to join
- Women aged 18-36 years
- Body mass index (BMI) between 18 and 26
- Prolactin within the laboratory normal range
- Couples affected by sterility able to treat by IUI (intrauterine insemination)
- Patients undergoing Menopur® treatment
- Normal thyroid function
Show all 9Show fewer
- Regular menses (21-35 days)
- Couples willing to participate in the study that have signed the informed consent form
- Seminal sample REM>3 million
Who cannot join
- Two previous ART (assisted reproductive technology) cycles without ongoing pregnancy
- Policystic ovarian syndrome
- Evidence of significant bacterial infection in the seminogram of the couple in the preceding 6 months
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Spain7 sites
Investigational site
Barcelona, Barcelona
Investigational site
Ciudad Real, Ciudad Real
Investigational site
Girona, Gerona
Investigational site
La Rioja, La Rioja
Investigational site
Navarra, Navarre
Investigational site
Reus, Tarragona
Investigational site
Valladolid, Valladolid
About this study
Official title: Comparative Assessment of the Clinical Utility of Ovarian Stimulation With Menotropin Versus Menotropin Plus GnRH Antagonist Following Two Protocols of Ovulation Induction for Intrauterine Insemination
To assess the effectiveness of protocols of ovarian hyperstimulation combining urinary gonadotrophins + GnRH antagonist vs urinary gonadotrophins, to achieve clinical pregnancy in females undergoing intrauterine insemination.
Study hypothesis: protocols combining urinary gonadotrophins + GnRH antagonist should be more effective than monotherapy.
- Conditions
- Sterility
- Being tested
- hMG-HP, hMG + GnRH antagonist
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hMG-HPDrug
hMG + GnRH antagonistDrug
| Study group | Role | What they receive |
|---|---|---|
| hMG-HP | Patients with a condition Receives: Drug: hMG-HP | |
| hMG-HP + GnRH antagonist | Patients with a condition Receives: Drug: hMG + GnRH antagonist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy rate
Measured: 30 days
Secondary outcomes (1)
Live birth rate
Measured: 40 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2011 (estimated)
- Study startNov 2006
- Primary completionOct 2008
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SterilityStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferring Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ferring SAU
- Investigators
- Clinical Development Support, Study director, Ferring Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01331733
- Sponsor's protocol ID
- FER-MEN-2006-01
- Acronym
- PROMENIA
- Status last verified
- Apr 2011
- First submitted
- 6 Apr 2011
- Last updated
- 8 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Assessment of the Clinical Utility of Ovarian Stimulation With Menotropin Versus Menotropin Plus GnRH Antagonist Following Two Protocols of Ovulation Induction for Intrauterine Insemination
- ClinicalTrials.gov ID
- NCT01331733
- Acronym / sponsor ID
- PROMENIA / FER-MEN-2006-01
- Conditions
- Sterility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Ferring SAU
- Study start
- Nov 2006
- Primary completion
- Oct 2008 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 8 Apr 2011 (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.
To assess the effectiveness of protocols of ovarian hyperstimulation combining urinary gonadotrophins + GnRH antagonist vs urinary gonadotrophins, to achieve clinical pregnancy in females undergoing intrauterine insemination.
Study hypothesis: protocols combining urinary gonadotrophins + GnRH antagonist should be more effective than monotherapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hMG-HP | – | Drug: hMG-HPPatients with a condition |
| hMG-HP + GnRH antagonist | – | Drug: hMG + GnRH antagonistPatients with a condition |
Who may qualify
- Ages
- 18 to 36 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Females affected by sterility able to undergo intrauterine insemination
Key inclusion criteria (9 listed)
- Women aged 18-36 years
- Body mass index (BMI) between 18 and 26
- Prolactin within the laboratory normal range
- Couples affected by sterility able to treat by IUI (intrauterine insemination)
- Patients undergoing Menopur® treatment
Key exclusion criteria (3 listed)
- Two previous ART (assisted reproductive technology) cycles without ongoing pregnancy
- Policystic ovarian syndrome
- Evidence of significant bacterial infection in the seminogram of the couple in the preceding 6 months
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 |
|---|---|---|
| hMG-HP | Drug | hMG-HP |
| hMG + GnRH antagonist | Drug | hMG-HP + GnRH antagonist |
Primary outcome
Clinical pregnancy rate
Time frame: 30 days
1 secondary outcome
Live birth rate
Time frame: 40 weeks
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 8 Apr 2011.
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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.
Clinical Development Support study director
Ferring Pharmaceuticals
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sterility, run by Ferring Pharmaceuticals at 7 sites 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 9 inclusion and 3 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 8 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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.
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?
Clinical pregnancy rate (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Apr 2011.