Assessment of the Effectiveness and Tolerability of Ovarian Hyperstimulation

• Status: Completed
• Trial end date: 2010-07-01
• Target enrollment: 0
• Participant gender: Female

Summary

The aim of the study is to assess the effectiveness of 5 mixed protocols of ovarian hyperstimulation with urinary gonadotrophins to achieve clinical pregnancy in females undergoing assisted reproductive techniques (IVF/ICSI) (in-vitro fertilisation/intracytoplasmic sperm injection).

Study hypothesis: mixed protocols with urinary FSH (follicle-stimulating hormone) and urinary hMG (human menopausal gonadotropin)should be more effective than monotherapy.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ferring Pharmaceuticals
• Collaborator: Ferring SAU

Criteria

Inclusion Criteria:

• Body mass index (BMI) between 18 and 30

• Prolactin within the laboratory normal range

• Couples affected by sterility able to treat by IVF/ICSI (in-vitro fertilisation/intracytoplasmic sperm injection)

• Patients undergoing Menopur® and/or Bravelle® treatment

• Normal thyroid function

• Women not receiving clomifen citrate or gonadotrophins within one month prior study start

• Couples willing to participate in the study that have signed the informed consent form

Exclusion Criteria:

• Failure in 3 previous cycles of assisted reproduction IVF/ICSI (in-vitro fertilisation/intracytoplasmic sperm injection)

• Policystic ovarian syndrome

• 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

• Antecedents of severe ovarian hyperstimulation syndrome (OHSS)

• Important systemic disease

• Pregnancy or contraindication to pregnancy