NCT01330771

Brief Summary

To assess the effectiveness of a protocol of ovarian hyperstimulation combining urinary gonadotrophins + recombinant gonadotrophins, to achieve clinical pregnancy in females undergoing IVF. Study hypothesis: to assess the effectiveness of protocols combining urinary gonadotrophins + recombinant gonadotrophins

Trial Health

87
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2006

Geographic Reach
1 country

1 active site

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

October 1, 2006

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

April 6, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 7, 2011

Completed
Last Updated

April 7, 2011

Status Verified

April 1, 2011

Enrollment Period

1.7 years

First QC Date

April 6, 2011

Last Update Submit

April 6, 2011

Conditions

Sterility

Outcome Measures

Primary Outcomes (1)

  • Clinical pregnancy rate

    30 days

Secondary Outcomes (1)

  • Biochemical pregnancy rate

    16 days

Study Arms (1)

hMG-HP/r-FSH

Patients with a condition

Drug: hMG-HP/r-FSH

Interventions

hMG-HP/r-FSHDRUG
hMG-HP/r-FSH

Eligibility Criteria

Age18 Years - 38 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Females affected by sterility able to undergo IVF

You may qualify if:

  • Women aged 18-38 years
  • Body mass index (BMI) between 18 and 30
  • Women classified as normogonadotrophin patients. Not more than 3 previous cycles of ART (assisted reproductive technology)
  • Testosterona, FSH (follicle-stimulating hormone), LH (luteinizing hormone) and Prolactin serum levels during the early folicular phase (days 2-4 of the cycle) within the laboratory normal range
  • No administration of clomiphen citrate or gonadotropins during the month prior to the start of the study

You may not qualify if:

  • Failure in previous cycles of assisted reproduction IVF/ICSI (in-vitro fertilisation/intracytoplasmic sperm injection)
  • Seminal samples not apt for IVF-ICSI (according to the criteria of each center). Evidence of significant bacterial infection in the seminogram of the couple in the preceding 6 months
  • Data suggestive of possible ovarian failure
  • Antecedents of severe ovarian hyperstimulation syndrome (OHSS)
  • Important systemic disease
  • Pregnancy or contraindication to pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Investigational site

Valencia, Valencia, 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 7, 2011

Study Start

October 1, 2006

Primary Completion

June 1, 2008

Study Completion

September 1, 2008

Last Updated

April 7, 2011

Record last verified: 2011-04

Locations

ES(1)