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

Ferring Pharmaceuticals1 site in 1 country51 target enrollmentOctober 2006

ConditionsSterility

InterventionshMG-HP/r-FSH

DrugshMG-HP/r-FSH

Overview

Phase: Not Applicable
Intervention: hMG-HP/r-FSH
Conditions: Sterility
Sponsor: Ferring Pharmaceuticals
Enrollment: 51
Locations: 1
Primary Endpoint: Clinical pregnancy rate
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

October 2006

End Date

September 2008

Last Updated

15 years ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

Ferring Pharmaceuticals

Eligibility 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