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Completed

NCT Number: NCT01331720

Assessment of the Effectiveness and Tolerability of Ovarian Hyperstimulation

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.

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Key information

Conditions

Sterility Genital Diseases Infertility Urogenital Diseases

Sex eligibility

Female

Study type

Observational

Primary location

Investigational site, Albacete, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

hMG-HP

Drug

Primary outcomes

  1. Clinical pregnancy rate

    Time frame: 0-30 days

Secondary outcomes

  1. Biochemical pregnancy rate

    Time frame: 0-16 days

Sponsors and collaborators

Lead sponsor

Ferring Pharmaceuticals

Industry

Collaborators

  • Ferring SAU

Registry information

Official study 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

Acronym: DESCARTES

Important dates

Study start
2007
Primary completion
2009
Study completion
2010
First posted
Apr 8, 2011
Registry last updated
Apr 8, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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