Assessment of the Effectiveness of Menopur in Intrauterine Insemination
This study has been completed.
Sponsor:
Ferring Pharmaceuticals
Collaborator:
Ferring SAU
Information provided by:
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01354834
First received: May 16, 2011
Last updated: NA
Last verified: May 2011
History: No changes posted
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Purpose
The purpose of this study is to assess the effectiveness of Menopur to achieve clinical pregnancy in females undergoing intrauterine insemination in clinical practice.
| Condition | Intervention |
|---|---|
|
Infertility |
Drug: hMG |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Assessment of the Clinical Efficacy of Menopur® in Intrauterine Artificial Insemination (From Partner or From Donor) |
Resource links provided by NLM:
Further study details as provided by Ferring Pharmaceuticals:
Primary Outcome Measures:
- Clinical pregnancy rate [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Live birth rate [ Time Frame: 40 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 207 |
| Study Start Date: | March 2004 |
| Study Completion Date: | April 2006 |
| Primary Completion Date: | December 2005 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| hMG |
Drug: hMG
Patients with a condition
|
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Females affected by infertility able to undergo intrauterine insemination
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Contraindications to intrauterine insemination
- Contraindications to Menopur
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01354834
Locations
| Spain | |
| Investigational site | |
| Elche, Alicante, Spain | |
| Investigational site | |
| Las Palmas, Grand Canaria, Spain | |
| Investigational site | |
| Santiago, La Coruña, Spain | |
| Investigational site | |
| Reus, Tarragona, Spain | |
| Investigational site | |
| Albacete, Spain | |
| Investigational site | |
| Alicante, Spain | |
| Investigational site | |
| Almería, Spain | |
| Investigational site | |
| Barcelona, Spain | |
| Investigational site | |
| Burgos, Spain | |
| Investigational site | |
| León, Spain | |
| Investigational site | |
| Madrid, Spain | |
| Investigational site | |
| Sevilla, Spain | |
| Investigational site | |
| Toldeo, Spain | |
| Investigational site | |
| Valladolid, Spain | |
Sponsors and Collaborators
Ferring Pharmaceuticals
Ferring SAU
Investigators
| Study Director: | Clinical Development Support | Ferring Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Clinical Development Support, Ferring Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01354834 History of Changes |
| Other Study ID Numbers: | FER-MEN-2003-01 |
| Study First Received: | May 16, 2011 |
| Last Updated: | May 16, 2011 |
| Health Authority: | Spain: Agencia Española de Medicamentos y Productos Sanitarios |
Additional relevant MeSH terms:
|
Infertility Genital Diseases, Male Genital Diseases, Female |
ClinicalTrials.gov processed this record on May 16, 2013