NCT01331720

Brief Summary

The aim of the study is to assess the effectiveness of 5 mixed protocols of ovarian hyperstimulation with urinary gonadotrophins to achieve clinical pregnancy in females undergoing assisted reproductive techniques (IVF/ICSI) (in-vitro fertilisation/intracytoplasmic sperm injection). Study hypothesis: mixed protocols with urinary FSH (follicle-stimulating hormone) and urinary hMG (human menopausal gonadotropin)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
279

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2007

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

November 1, 2007

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
9 months 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

1.3 years

First QC Date

April 6, 2011

Last Update Submit

April 7, 2011

Conditions

STERILITY

Outcome Measures

Primary Outcomes (1)

  • Clinical pregnancy rate

    0-30 days

Secondary Outcomes (1)

  • Biochemical pregnancy rate

    0-16 days

Study Arms (5)

FSH:LH 1:1 - Treatment Group A

Patients with a condition LH (luteinizing hormone)

Drug: hMG-HP

FSH:LH 3:2 - Treatment Group B

Patients with a condition

Drug: hMG-HP

FSH:LH 3:1 - Treatment Group C

Patients with a condition

Drug: hMG-HP

FSH:LH 3:0 - Treatment Group D

Patients with a condition

Drug: hMG-HP

Initially FSH:LH 3:0 and on S6 FSH:LH 1:1 - Treatment Group E

Patients with a condition

Drug: hMG-HP

Interventions

hMG-HPDRUG
FSH:LH 1:1 - Treatment Group AFSH:LH 3:0 - Treatment Group DFSH:LH 3:1 - Treatment Group CFSH:LH 3:2 - Treatment Group BInitially FSH:LH 3:0 and on S6 FSH:LH 1:1 - Treatment Group E

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Females affected by sterility able to undergo IVF/ICSI

You may qualify if:

  • Body mass index (BMI) between 18 and 30
  • Prolactin within the laboratory normal range
  • Couples affected by sterility able to treat by IVF/ICSI (in-vitro fertilisation/intracytoplasmic sperm injection)
  • Patients undergoing Menopur® and/or Bravelle® treatment
  • Normal thyroid function
  • Women not receiving clomifen citrate or gonadotrophins within one month prior study start
  • Couples willing to participate in the study that have signed the informed consent form

You may not qualify if:

  • Failure in 3 previous cycles of assisted reproduction IVF/ICSI (in-vitro fertilisation/intracytoplasmic sperm injection)
  • Policystic ovarian syndrome
  • 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
  • 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 (14)

Investigational site

Albacete, Albacete, Spain

Location

Investigational site

Alicante, Alicante, Spain

Location

Investigational site

Elche, Alicante, Spain

Location

Investigational site

Badajoz, Badajoz, Spain

Location

Investigational site

Castellon, Castellón, Spain

Location

Investigational site

Santiago de Compostela, La Coruña, Spain

Location

Investigational site

Mallorca, Mallorca, Spain

Location

Investigational site

Murcia, Murcia, Spain

Location

Investigational site

Málaga, Málaga, Spain

Location

Investigational site

Navarra, Pamplona, Spain

Location

Investigational site

Gijón, Principality of Asturias, Spain

Location

Investigational site Sta. Cruz

Santa Cruz de Tenerife, Tenerife, Spain

Location

Investigational site

Valencia, Valencia, Spain

Location

Investigational site

Zaragoza, Zaragoza, 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, 2007

Primary Completion

March 1, 2009

Study Completion

July 1, 2010

Last Updated

April 8, 2011

Record last verified: 2011-04

Locations

ES(14)