NCT01331733

Brief Summary

To assess the effectiveness of protocols of ovarian hyperstimulation combining urinary gonadotrophins + GnRH antagonist vs urinary gonadotrophins, to achieve clinical pregnancy in females undergoing intrauterine insemination. Study hypothesis: protocols combining urinary gonadotrophins + GnRH antagonist should be more effective than monotherapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
131

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2006

Typical duration for all trials

Geographic Reach
1 country

7 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

November 1, 2006

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

April 6, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 8, 2011

Completed
Last Updated

April 8, 2011

Status Verified

April 1, 2011

Enrollment Period

1.9 years

First QC Date

April 6, 2011

Last Update Submit

April 7, 2011

Conditions

Sterility

Outcome Measures

Primary Outcomes (1)

  • Clinical pregnancy rate

    30 days

Secondary Outcomes (1)

  • Live birth rate

    40 weeks

Study Arms (2)

hMG-HP

Patients with a condition

Drug: hMG-HP

hMG-HP + GnRH antagonist

Patients with a condition

Drug: hMG + GnRH antagonist

Interventions

hMG-HPDRUG
hMG-HP
hMG + GnRH antagonistDRUG
hMG-HP + GnRH antagonist

Eligibility Criteria

Age18 Years - 36 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Females affected by sterility able to undergo intrauterine insemination

You may qualify if:

  • Women aged 18-36 years
  • Body mass index (BMI) between 18 and 26
  • Prolactin within the laboratory normal range
  • Couples affected by sterility able to treat by IUI (intrauterine insemination)
  • Patients undergoing Menopur® treatment
  • Normal thyroid function
  • Regular menses (21-35 days)
  • Couples willing to participate in the study that have signed the informed consent form
  • Seminal sample REM\>3 million

You may not qualify if:

  • Two previous ART (assisted reproductive technology) cycles without ongoing pregnancy
  • Policystic ovarian syndrome
  • Evidence of significant bacterial infection in the seminogram of the couple in the preceding 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Investigational site

Barcelona, Barcelona, Spain

Location

Investigational site

Ciudad Real, Ciudad Real, Spain

Location

Investigational site

Girona, Gerona, Spain

Location

Investigational site

La Rioja, La Rioja, Spain

Location

Investigational site

Navarra, Navarre, Spain

Location

Investigational site

Reus, Tarragona, Spain

Location

Investigational site

Valladolid, 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

April 6, 2011

First Posted

April 8, 2011

Study Start

November 1, 2006

Primary Completion

October 1, 2008

Study Completion

March 1, 2009

Last Updated

April 8, 2011

Record last verified: 2011-04

Locations

ES(7)