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Completed

NCT Number: NCT02835469

A Study on Efficacy and Safety of 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

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

19 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

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

Gwangju, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Menotrophin

Drug

Other names: Menopur® Multidose

Primary outcomes

  1. Ongoing pregnancy rate

    Time frame: 10-11 weeks after embryo transfer

    Defined as presence of at least 1 intrauterine pregnancy with a viable fetus

Secondary outcomes

  1. Mean Follicle Stimulating Hormone (FSH) level

    Time frame: At baseline and last stimulation day (max 20 days after start of stimulation)

  2. Mean Luteinizing Hormone (LH) level

    Time frame: At baseline and last stimulation day (max 20 days after start of stimulation)

  3. Mean Estradiol 2 (E2) level

    Time frame: At baseline and last stimulation day (max 20 days after start of stimulation)

  4. Mean endometrial thickness

    Time frame: On last stimulation day (max 20 days after start of stimulation)

    Measured by transvaginal ultrasound

  5. Follicular development

    Time frame: On last stimulation day (max 20 days after start of stimulation)

    Number and size of follicles measured by transvaginal ultrasound

  6. Number of oocytes retrieved

    Time frame: 36 hours (±2h) after human Chorionic Gonadotrophin (hCG) administration

  7. Fertilization rate

    Time frame: 1 day after oocyte retrieval

    Number of oocytes with 2 pronuclei divided by number of metaphase II oocytes

Sponsors and collaborators

Lead sponsor

Ferring Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jul 18, 2016
Registry last updated
Mar 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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