A Study on Efficacy and Safety of Menopur® Multidose in Korean Female Patients With Infertility

Completed

• Conditions: Infertility
• Interventions: Drug: Menotrophin

• Registration Number: NCT02835469
• Lead Sponsor: Ferring Pharmaceuticals

Brief Summary

The purpose of this study is to investigate the ongoing pregnancy rates at 10-11 weeks after embryo transfer in patients treated with Menopur® Multidose

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-06-28
• Study First Submitted QC: 2016-07-13
• Study First Posted: 2016-07-18
• Primary Completion: 2019-02-01
• Study Completion: 2019-02-01
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-27
• Last Update Posted: 2019-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 412

Inclusion Criteria

• Decision made to prescribe Menopur® multidose according to Summary of product characteristics

• The study cycle will be either

  • 1st controlled ovarian stimulation cycle ever, or
  • 2nd controlled ovarian stimulation cycle ever, or
  • 1st or 2nd controlled ovarian stimulation cycle after having achieved ongoing pregnancy in a previous controlled ovarian stimulation cycle (note: the subject cannot be included if she has had made more than one failed cycle before the cycle resulting in ongoing pregnancy)

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Exclusion Criteria

• Known ovarian disease (e.g. ovarian cysts, polycystic ovarian disease etc.)

• Diagnosed as "poor responder", defined as either

  • >20 days of gonadotrophin stimulation in a previous controlled ovarian stimulation cycle, or
  • any previous cancellation of a controlled ovarian stimulation cycle due to limited follicular response, or
  • development of less than 4 follicles ≥15 mm in a previous controlled ovarian stimulation cycle

• Ovarian hyperstimulation syndrome (OHSS)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Menopur® Multidose	Menotrophin	Treatment according to routine clinical practice.

Primary Outcome Measures

Name	Time	Method
Ongoing pregnancy rate	10-11 weeks after embryo transfer	Defined as presence of at least 1 intrauterine pregnancy with a viable fetus

Secondary Outcome Measures

Name	Time	Method
Mean Luteinizing Hormone (LH) level	At baseline and last stimulation day (max 20 days after start of stimulation)
Mean Estradiol 2 (E2) level	At baseline and last stimulation day (max 20 days after start of stimulation)
Mean Follicle Stimulating Hormone (FSH) level	At baseline and last stimulation day (max 20 days after start of stimulation)
Mean endometrial thickness	On last stimulation day (max 20 days after start of stimulation)	Measured by transvaginal ultrasound
Fertilization rate	1 day after oocyte retrieval	Number of oocytes with 2 pronuclei divided by number of metaphase II oocytes
Number of oocytes retrieved	36 hours (±2h) after human Chorionic Gonadotrophin (hCG) administration
Follicular development	On last stimulation day (max 20 days after start of stimulation)	Number and size of follicles measured by transvaginal ultrasound

Trial Locations

Locations (1)

CL Hospital (there may be other sites in this country); 🇰🇷 Gwangju, Korea, Republic of