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Completed

NCT Number: NCT01330784

Assessment of the Therapeutic Utility of hMG-HP

To assess the effectiveness of a protocol of ovarian hyperstimulation with urinary gonadotrophins, to achieve clinical pregnancy in females undergoing IVF.

Study hypothesis: to assess the effectiveness of a protocol of urinary gonadotrophins

Completed

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Key information

Conditions

Sterility Genital Diseases Infertility Urogenital Diseases

Age range

18 year–38 year

Sex eligibility

Female

Study type

Observational

Primary location

Investigational site

Valencia, Spain

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Women aged 18-38 years
  • Body mass index (BMI) between 18 and 30
  • Women classified as normogonadotrophin patients. Not more than 3 previous cycles of ART (assisted reproductive technology)
  • Testosterona, FSH (follicle-stimulating hormone) LH (luteinizing hormone) and Prolactin serum levels during the early folicular phase (days 2-4 of the cycle) within the laboratory normal range
  • No administration of clomiphen citrate or gonadotropins during the month prior to the start of the study

Exclusion criteria

  • Failure in previous cycles of assisted reproduction IVF/ICSI (in-vitro fertilisation/intracytoplasmic sperm injection)
  • 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
  • Data suggestive of possible ovarian failure
  • 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: 30 days

Secondary outcomes

  1. Biochemical pregnancy rate

    Time frame: 16 days

Sponsors and collaborators

Lead sponsor

Ferring Pharmaceuticals

Industry

Collaborators

  • Ferring SAU

Registry information

Official study title

Assessment of the Therapeutic Utility of hMG-HP Within a Protocol of Controlled Ovarian Hyperstimulation in IVF in Normoresponders Women Undergoing Downregulation With GnRH Antagonist

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Apr 7, 2011
Registry last updated
Apr 7, 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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