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

Completed

• Conditions: Sterility
• Interventions: Drug: hMG-HP/r-FSH

• Registration Number: NCT01330771
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10
• Primary Completion: 2008-06
• Study Completion: 2008-09
• Status Verified: 2011-04
• Study First Submitted: 2011-04-06
• Study First Submitted QC: 2011-04-06
• Last Update Submitted: 2011-04-06
• Study First Posted: 2011-04-07
• Last Update Posted: 2011-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 51

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
hMG-HP/r-FSH	hMG-HP/r-FSH	Patients with a condition

Primary Outcome Measures

Name	Time	Method
Clinical pregnancy rate	30 days

Secondary Outcome Measures

Name	Time	Method
Biochemical pregnancy rate	16 days

Trial Locations

Locations (1)

Investigational site; 🇪🇸 Valencia, Spain