NCT01354834

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
207

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2004

Typical duration for all trials

Geographic Reach
1 country

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
5.1 years until next milestone

First Submitted

Initial submission to the registry

May 16, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 17, 2011

Completed
Last Updated

March 28, 2025

Status Verified

May 1, 2011

Enrollment Period

1.8 years

First QC Date

May 16, 2011

Last Update Submit

March 27, 2025

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

  • Clinical pregnancy rate

    30 days

Secondary Outcomes (1)

  • Live birth rate

    40 weeks

Study Arms (1)

hMG

Drug: hMG

Interventions

hMGDRUG

Patients with a condition

hMG

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Females affected by infertility able to undergo intrauterine insemination

You may qualify if:

  • 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

You may not qualify if:

  • Contraindications to intrauterine insemination
  • Contraindications to Menopur

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Investigational site

Elche, Alicante, Spain

Location

Investigational site

Las Palmas, Grand Canaria, Spain

Location

Investigational site

Santiago, La Coruña, Spain

Location

Investigational site

Reus, Tarragona, Spain

Location

Investigational site

Albacete, Spain

Location

Investigational site

Alicante, Spain

Location

Investigational site

Almería, Spain

Location

Investigational site

Barcelona, Spain

Location

Investigational site

Burgos, Spain

Location

Investigational site

León, Spain

Location

Investigational site

Madrid, Spain

Location

Investigational site

Seville, Spain

Location

Investigational site

Toldeo, Spain

Location

Investigational site

Valladolid, Spain

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Clinical Development Support

    Ferring Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 16, 2011

First Posted

May 17, 2011

Study Start

March 1, 2004

Primary Completion

December 1, 2005

Study Completion

April 1, 2006

Last Updated

March 28, 2025

Record last verified: 2011-05

Locations

ES(14)