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Assessment of the Effectiveness of Menopur in Intrauterine Insemination

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ClinicalTrials.gov Identifier: NCT01354834
Recruitment Status : Completed
First Posted : May 17, 2011
Last Update Posted : May 17, 2011
Sponsor:
Collaborator:
Ferring SAU
Information provided by:
Ferring Pharmaceuticals

Brief 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.

Condition or disease Intervention/treatment
Infertility Drug: hMG

Study Type : Observational
Actual Enrollment : 207 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of the Clinical Efficacy of Menopur® in Intrauterine Artificial Insemination (From Partner or From Donor)
Study Start Date : March 2004
Primary Completion Date : December 2005
Study Completion Date : April 2006

Group/Cohort Intervention/treatment
hMG Drug: hMG
Patients with a condition



Primary Outcome Measures :
  1. Clinical pregnancy rate [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Live birth rate [ Time Frame: 40 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Clinical Development Support, Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01354834     History of Changes
Other Study ID Numbers: FER-MEN-2003-01
First Posted: May 17, 2011    Key Record Dates
Last Update Posted: May 17, 2011
Last Verified: May 2011

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Menotropins
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs