Assessment of the Therapeutic Utility of r-FSH in Association With hMG-HP

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01330771
Recruitment Status : Completed
First Posted : April 7, 2011
Last Update Posted : April 7, 2011
Ferring SAU
Information provided by:
Ferring Pharmaceuticals

Brief Summary:

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

Study hypothesis: to assess the effectiveness of protocols combining urinary gonadotrophins + recombinant gonadotrophins

Condition or disease Intervention/treatment
Sterility Drug: hMG-HP/r-FSH

Study Type : Observational
Actual Enrollment : 51 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of the Therapeutic Utility of r-FSH in Association With hMG-HP Within a Protocol of Controlled Ovarian Hyperstimulation in IVF in Normoresponders Women Undergoing Downregulation With GnRH Antagonist
Study Start Date : October 2006
Actual Primary Completion Date : June 2008
Actual Study Completion Date : September 2008

Group/Cohort Intervention/treatment
Patients with a condition
Drug: hMG-HP/r-FSH

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

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

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01330771

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

Responsible Party: Clinical Development Support, Ferring Pharmaceuticals Identifier: NCT01330771     History of Changes
Other Study ID Numbers: FER-GON-2004-01
First Posted: April 7, 2011    Key Record Dates
Last Update Posted: April 7, 2011
Last Verified: April 2011

Additional relevant MeSH terms:
Genital Diseases, Male
Genital Diseases, Female