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NCT01354834 Clinical Trial

Assessment of the Effectiveness of Menopur in Intrauterine Insemination

Infertility Clinical Trial

Official title:
Assessment of the Clinical Efficacy of Menopur® in Intrauterine Artificial Insemination (From Partner or From Donor)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01354834
Other study ID # FER-MEN-2003-01
Secondary ID
Status Completed
Phase N/A
First received May 16, 2011
Last updated May 16, 2011
Start date March 2004
Est. completion date April 2006

Study information
Verified date May 2011
Source Ferring Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority Spain: Agencia Española de Medicamentos y Productos Sanitarios
Study type Observational

Clinical 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.

Recruitment information / eligibility
Status Completed
Enrollment 207
Est. completion date April 2006
Est. primary completion date December 2005
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• hMG
Patients with a condition

Locations
Country Name City State
Spain Investigational site Albacete
Spain Investigational site Alicante
Spain Investigational site Almería
Spain Investigational site Barcelona
Spain Investigational site Burgos
Spain Investigational site Elche Alicante
Spain Investigational site Las Palmas Grand Canaria
Spain Investigational site León
Spain Investigational site Madrid
Spain Investigational site Reus Tarragona
Spain Investigational site Santiago La Coruña
Spain Investigational site Sevilla
Spain Investigational site Toldeo
Spain Investigational site Valladolid

Sponsors (2)
Lead Sponsor Collaborator
Ferring Pharmaceuticals Ferring SAU

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Clinical pregnancy rate 30 days No
Secondary Live birth rate 40 weeks No
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