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

NCT ID: NCT02835469

Last Updated: 2019-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

412 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-30

Study Completion Date

2019-02-01

Brief Summary

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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

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Conditions

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Infertility

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Menopur® Multidose

Treatment according to routine clinical practice.

Menotrophin

Intervention Type DRUG

Interventions

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Menotrophin

Intervention Type DRUG

Other Intervention Names

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Menopur® Multidose

Eligibility Criteria

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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)
Minimum Eligible Age

19 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ferring Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Development Support

Role: STUDY_DIRECTOR

Ferring Pharmaceuticals

Locations

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CL Hospital (there may be other sites in this country)

Gwangju, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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000258

Identifier Type: -

Identifier Source: org_study_id

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