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

This study has been completed.
Sponsor:
Collaborator:
Ferring SAU
Information provided by:
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01330771
First received: April 6, 2011
Last updated: NA
Last verified: April 2011
History: No changes posted
  Purpose

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 Intervention
Sterility
 Drug: hMG-HP/r-FSH

Study Type: Observational
Study Design: 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

Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • Clinical pregnancy rate [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Biochemical pregnancy rate [ Time Frame: 16 days ] [ Designated as safety issue: No ]

Enrollment: 51
Study Start Date: October 2006
Study Completion Date: September 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
hMG-HP/r-FSH
Patients with a condition
 Drug: hMG-HP/r-FSH

  Eligibility

Ages Eligible for Study:   18 Years to 38 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Females affected by sterility able to undergo IVF

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01330771

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

No publications provided

Responsible Party: Clinical Development Support, Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01330771     History of Changes
Other Study ID Numbers: FER-GON-2004-01
Study First Received: April 6, 2011
Last Updated: April 6, 2011
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

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

ClinicalTrials.gov processed this record on June 18, 2013