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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

April 6, 2011
April 7, 2011
November 2007
March 2009   (final data collection date for primary outcome measure)
Clinical pregnancy rate [ Time Frame: 0-30 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01331720 on ClinicalTrials.gov Archive Site
Biochemical pregnancy rate [ Time Frame: 0-16 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Assessment of the Effectiveness and Tolerability of Ovarian Hyperstimulation
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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Females affected by sterility able to undergo IVF/ICSI

STERILITY
Drug: hMG-HP
  • FSH:LH 1:1 - Treatment Group A

    Patients with a condition

    LH (luteinizing hormone)

    Intervention: Drug: hMG-HP
  • FSH:LH 3:2 - Treatment Group B
    Patients with a condition
    Intervention: Drug: hMG-HP
  • FSH:LH 3:1 - Treatment Group C
    Patients with a condition
    Intervention: Drug: hMG-HP
  • FSH:LH 3:0 - Treatment Group D
    Patients with a condition
    Intervention: Drug: hMG-HP
  • Initially FSH:LH 3:0 and on S6 FSH:LH 1:1 - Treatment Group E
    Patients with a condition
    Intervention: Drug: hMG-HP
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
279
July 2010
March 2009   (final data collection date for primary outcome measure)

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
Female
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01331720
FER-MEN-2006-03
No
Clinical Development Support, Ferring Pharmaceuticals
Ferring Pharmaceuticals
Ferring SAU
Study Director: Clinical Development Support Ferring Pharmaceuticals
Ferring Pharmaceuticals
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP