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

This study has been completed.
Sponsor:
Collaborator:
Ferring SAU
Information provided by:
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01331720
First received: April 6, 2011
Last updated: April 7, 2011
Last verified: April 2011
  Purpose

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.


Condition Intervention
STERILITY
Drug: hMG-HP

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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

Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • Clinical pregnancy rate [ Time Frame: 0-30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Biochemical pregnancy rate [ Time Frame: 0-16 days ] [ Designated as safety issue: No ]

Enrollment: 279
Study Start Date: November 2007
Study Completion Date: July 2010
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Females affected by sterility able to undergo IVF/ICSI

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01331720

Locations
Spain
Investigational site
Elche, Alicante, Spain
Investigational site
Gijón, Asturias, Spain
Investigational site
Santiago de Compostela, La Coruña, Spain
Investigational site
Navarra, Pamplona, Spain
Investigational site
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 Sta. Cruz
Tenerife, Spain
Investigational site
Valencia, Spain
Investigational site
Zaragoza, Spain
Sponsors and Collaborators
Ferring Pharmaceuticals
Ferring SAU
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals
  More Information

No publications provided

Responsible Party: Clinical Development Support, Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01331720     History of Changes
Other Study ID Numbers: FER-MEN-2006-03
Study First Received: April 6, 2011
Last Updated: April 7, 2011
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Additional relevant MeSH terms:
Ovarian Hyperstimulation Syndrome
Infertility
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Genital Diseases, Male

ClinicalTrials.gov processed this record on April 17, 2014