Assessment of the Effectiveness of Menopur in Intrauterine Insemination

This study has been completed.
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 22, 2014