Assessment of the Effectiveness and Tolerability of Ovarian Hyperstimulation

Completed

• Conditions: STERILITY
• Interventions: Drug: hMG-HP

• Registration Number: NCT01331720
• Lead Sponsor: Ferring Pharmaceuticals

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Primary Completion: 2009-03
• Study Completion: 2010-07
• Status Verified: 2011-04
• Study First Submitted: 2011-04-06
• Study First Submitted QC: 2011-04-07
• Last Update Submitted: 2011-04-07
• Study First Posted: 2011-04-08
• Last Update Posted: 2011-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 279

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
FSH:LH 1:1 - Treatment Group A	hMG-HP	Patients with a condition LH (luteinizing hormone)
FSH:LH 3:2 - Treatment Group B	hMG-HP	Patients with a condition
FSH:LH 3:1 - Treatment Group C	hMG-HP	Patients with a condition
FSH:LH 3:0 - Treatment Group D	hMG-HP	Patients with a condition
Initially FSH:LH 3:0 and on S6 FSH:LH 1:1 - Treatment Group E	hMG-HP	Patients with a condition

Primary Outcome Measures

Name	Time	Method
Clinical pregnancy rate	0-30 days

Secondary Outcome Measures

Name	Time	Method
Biochemical pregnancy rate	0-16 days

Trial Locations

Locations (2)

Investigational site; 🇪🇸 Zaragoza, Spain

Investigational site Sta. Cruz; 🇪🇸 Tenerife, Spain