Clinical Trial: Evaluation of Efficacy and Safety of Highly Purified Urofollitropin for Ovulation Induction in Chinese Females
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Randomized, Assessor-blinded, Parallel Group, Multi-center, Non-inferiority Study Investigating the Efficacy and Safety of Highly Purified Urofollitropin for Injection Compared to Recombinant Human
Brief Summary: Evaluate the Efficacy and Safety of Highly Purified Urofollitropin for Injection Compared to Recombinant Human Follitropin Alfa for Injection for Ovulation Induction in Chinese females
Detailed Summary:
Sponsor: Ferring Pharmaceuticals
Current Primary Outcome: The ovulation rate defined as the percentage of subjects who present ovulation [ Time Frame: From 6 days up to 7 weeks post hCG (human chorionic gonadotropin) administration ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- The positive serum progesterone rate [ Time Frame: 6~9 days post hCG administration ]
- The positive serum β-hCG/hCG rate [ Time Frame: 18~22 days post hCG administration ]
- The clinical pregnancy rate [ Time Frame: 6~7 weeks post hCG administration ]Regardless of fetal heart beat
- The clinical pregnancy rate [ Time Frame: 6~7 weeks post hCG administration ]With fetal heart beat
- The ongoing pregnancy rate [ Time Frame: 11~12 weeks post hCG administration ]
- The follicular development [ Time Frame: On the day of hCG administration ]
- Endometrial thickness [ Time Frame: On the day of hCG administration ]
- Total FSH (Follicle-stimulating hormone) dose administered [ Time Frame: On the day of hCG administration ]
- Number of FSH treatment days [ Time Frame: On the day of hCG administration ]
- Frequency and severity of adverse events [ Time Frame: Expected maximum of 6 months ]
- Frequency and severity of injection site reactions [ Time Frame: Day 1 up to Day 28 of the ovarian stimulation period ]
- Serum estradiol (E2) levels [ Time Frame: On the day of hCG administration ]
Original Secondary Outcome:
- The positive serum progesterone rate [ Time Frame: 6~9 days post hCG administration ]
- The positive serum β-hCG rate [ Time Frame: 18~22 days post hCG administration ]
- The clinical pregnancy rate [ Time Frame: 6~7 weeks post hCG administration ]Regardless of fetal heart beat
- The clinical pregnancy rate [ Time Frame: 6~7 weeks post hCG administration ]With fetal heart beat
- The ongoing pregnancy rate [ Time Frame: 11~12 weeks post hCG administration ]
- The follicular development [ Time Frame: On the day of hCG administration ]
- Endometrial thickness [ Time Frame: On the day of hCG administration ]
- Total FSH (Follicle-stimulating hormone) dose administered [ Time Frame: On the day of hCG administration ]
- Number of FSH treatment days [ Time Frame: On the day of hCG administration ]
- Frequency and severity of adverse events [ Time Frame: Expected maximum of 6 months ]
- Frequency and severity of injection site reactions [ Time Frame: Day 1 up to Day 28 of the ovarian stimulation period ]
- Serum estradiol (E2) levels [ Time Frame: On the day of hCG administration ]
Information By: Ferring Pharmaceuticals
Dates:
Date Received: August 12, 2013
Date Started: October 2013
Date Completion:
Last Updated: August 20, 2015
Last Verified: August 2015