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

March 27, 2019 updated by: Ferring Pharmaceuticals

Non-Interventional Clinical Study on Efficacy and Safety of Highly Purified Human Menopausal Gonadotrophin (HP-hMG) Menopur® Multidose in Korean Female Patients With Infertility

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

412

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 38 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Fertility clinics

Description

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)

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Menopur® Multidose
Treatment according to routine clinical practice.
Drug: Menotrophin
Other Names:
  • Menopur® Multidose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ongoing pregnancy rate
Time Frame: 10-11 weeks after embryo transfer
Defined as presence of at least 1 intrauterine pregnancy with a viable fetus
10-11 weeks after embryo transfer

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ferring Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2016

Primary Completion (Actual)

February 1, 2019

Study Completion (Actual)

February 1, 2019

Study Registration Dates

First Submitted

June 28, 2016

First Submitted That Met QC Criteria

July 13, 2016

First Posted (Estimate)

July 18, 2016

Study Record Updates

Last Update Posted (Actual)

March 28, 2019

Last Update Submitted That Met QC Criteria

March 27, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 000258

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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