Assessment of the Effectiveness and Tolerability of Ovarian Hyperstimulation (DESCARTES)

April 7, 2011 updated by: Ferring Pharmaceuticals

Assessment of the Effectiveness and Tolerability of Ovarian Hyperstimulation Protocols Which Are the Most Common in Clinical Practice Using High Purified Gonadotrophins (u-FSH-HP y u-hMG-HP) in IVF/ICSI

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

279

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Albacete, Spain
        • Investigational Site
      • Alicante, Spain
        • Investigational Site
      • Badajoz, Spain
        • Investigational Site
      • Castellón, Spain
        • Investigational Site
      • Mallorca, Spain
        • Investigational Site
      • Murcia, Spain
        • Investigational Site
      • Málaga, Spain
        • Investigational Site
      • Tenerife, Spain
        • Investigational site Sta. Cruz
      • Valencia, Spain
        • Investigational Site
      • Zaragoza, Spain
        • Investigational Site
    • Alicante
      • Elche, Alicante, Spain
        • Investigational Site
    • Asturias
      • Gijón, Asturias, Spain
        • Investigational Site
    • La Coruña
      • Santiago de Compostela, La Coruña, Spain
        • Investigational Site
    • Pamplona
      • Navarra, Pamplona, Spain
        • Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Females affected by sterility able to undergo IVF/ICSI

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical pregnancy rate
Time Frame: 0-30 days
0-30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Biochemical pregnancy rate
Time Frame: 0-16 days
0-16 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ferring Pharmaceuticals

Collaborators

Ferring SAU

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

April 6, 2011

First Submitted That Met QC Criteria

April 7, 2011

First Posted (Estimate)

April 8, 2011

Study Record Updates

Last Update Posted (Estimate)

April 8, 2011

Last Update Submitted That Met QC Criteria

April 7, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FER-MEN-2006-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on STERILITY

Clinical Trials on hMG-HP

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United Arab Emirates

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe