InfertilityNCT01354834
Assessment of the Effectiveness of Menopur in Intrauterine Insemination
An observational study of Infertility, run by Ferring Pharmaceuticals at 14 sites in Spain.
Trial summary
The purpose of this study is to assess the effectiveness of Menopur to achieve clinical pregnancy in females undergoing intrauterine insemination in clinical practice. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- hMG
- How many people
- 207 participants
- Where
- 14 sitesSpain
- Study dates
- Mar 2004to Apr 2006
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Study population: Females affected by infertility able to undergo intrauterine insemination
Who may be able to join
- Infertile couples for over one year (primary or secondary) or infertile women (or not) with indication of PAI or DAI
- Seminal sample suitable for artificial insemination treatment according to the criterion of each centre
- Patient prescribed therapy with Menopur in artificial insemination
Who cannot join
- Contraindications to intrauterine insemination
- Contraindications to Menopur
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Spain14 sites
Investigational site
Albacete
Investigational site
Alicante
Investigational site
Almería
Investigational site
Barcelona
Investigational site
Burgos
Investigational site
Elche, Alicante
Investigational site
Las Palmas, Grand Canaria
Investigational site
León
Investigational site
Madrid
Investigational site
Reus, Tarragona
Investigational site
Santiago, La Coruña
Investigational site
Seville
Investigational site
Toldeo
Investigational site
Valladolid
About this study
Official title: Assessment of the Clinical Efficacy of Menopur® in Intrauterine Artificial Insemination (From Partner or From Donor)
The purpose of this study is to assess the effectiveness of Menopur to achieve clinical pregnancy in females undergoing intrauterine insemination in clinical practice.
- Conditions
- Infertility
- Being tested
- hMG
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hMGDrug
Patients with a condition
| Study group | Role | What they receive |
|---|---|---|
| hMG | Not described Receives: Drug: hMG |
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 posted17 May 2011 (estimated)
- Study startMar 2004
- Primary completionDec 2005
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 207 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
- NCT01354834
- Sponsor's protocol ID
- FER-MEN-2003-01
- Status last verified
- May 2011
- First submitted
- 16 May 2011
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Clinical Efficacy of Menopur® in Intrauterine Artificial Insemination (From Partner or From Donor)
- ClinicalTrials.gov ID
- NCT01354834
- Acronym / sponsor ID
- FER-MEN-2003-01
- Conditions
- Infertility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Ferring SAU
- Study start
- Mar 2004
- Primary completion
- Dec 2005 (actual)
- Study completion
- Apr 2006 (actual)
- First posted
- 17 May 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.
The purpose of this study is to assess the effectiveness of Menopur to achieve clinical pregnancy in females undergoing intrauterine insemination in clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hMG | – | Drug: hMG |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Females affected by infertility able to undergo intrauterine insemination
Key inclusion criteria (3 listed)
- Infertile couples for over one year (primary or secondary) or infertile women (or not) with indication of PAI or DAI
- Seminal sample suitable for artificial insemination treatment according to the criterion of each centre
- Patient prescribed therapy with Menopur in artificial insemination
Key exclusion criteria (2 listed)
- Contraindications to intrauterine insemination
- Contraindications to Menopur
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 |
|---|---|---|
| hMGPatients with a condition | Drug | hMG |
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 28 Mar 2025.
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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
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, run by Ferring Pharmaceuticals at 14 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 3 inclusion and 2 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 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 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 28 Mar 2025; AzTrials last refreshed its copy on 8 Nov 2026.