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Assessment of the Therapeutic Utility of hMG-HP

This study has been completed.
Ferring SAU
Information provided by:
Ferring Pharmaceuticals Identifier:
First received: April 6, 2011
Last updated: NA
Last verified: April 2011
History: No changes posted

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

Condition Intervention
Sterility Drug: hMG-HP

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

Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • Clinical pregnancy rate [ Time Frame: 30 days ]

Secondary Outcome Measures:
  • Biochemical pregnancy rate [ Time Frame: 16 days ]

Enrollment: 61
Study Start Date: October 2006
Study Completion Date: September 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients with a condition
Drug: hMG-HP


Ages Eligible for Study:   18 Years to 38 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Females affected by sterility able to undergo IVF

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01330784

Investigational site
Valencia, Spain
Sponsors and Collaborators
Ferring Pharmaceuticals
Ferring SAU
Study Director: Clinical Development Support Ferring Pharmaceuticals
  More Information

Responsible Party: Clinical Development Support, Ferring Pharmaceuticals Identifier: NCT01330784     History of Changes
Other Study ID Numbers: FER-GON-2004-02
Study First Received: April 6, 2011
Last Updated: April 6, 2011

Additional relevant MeSH terms:
Genital Diseases, Male
Genital Diseases, Female processed this record on August 21, 2017