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

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

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

Study Overview

• Status: Completed
• Conditions: Sterility
• Intervention / Treatment: Drug: hMG-HP/r-FSH

• Study Type: Observational
• Enrollment (Actual): 51

Contacts and Locations

Study Locations

• Spain
  • Valencia, Spain
    • Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 38 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Females affected by sterility able to undergo IVF

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Clinical pregnancy rate	30 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Biochemical pregnancy rate	16 days

Collaborators and Investigators

• Sponsor: Ferring Pharmaceuticals
• Collaborators: Ferring SAU

Study record dates

Study Major Dates

• Study Start: October 1, 2006
• Primary Completion (Actual): June 1, 2008
• Study Completion (Actual): September 1, 2008

Study Registration Dates

• First Submitted: April 6, 2011
• First Submitted That Met QC Criteria: April 6, 2011
• First Posted (Estimate): April 7, 2011

Study Record Updates

• Last Update Posted (Estimate): April 7, 2011
• Last Update Submitted That Met QC Criteria: April 6, 2011
• Last Verified: April 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: FER-GON-2004-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No