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

• Status: Completed
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: Female

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

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ferring Pharmaceuticals
• Collaborator: Ferring SAU

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