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Trial record 8 of 416 for:    Recruiting, Not yet recruiting, Available Studies | "Infertility"

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

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ClinicalTrials.gov Identifier: NCT02835469
Recruitment Status : Recruiting
First Posted : July 18, 2016
Last Update Posted : May 21, 2018
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment
Infertility Drug: Menotrophin

Study Type : Observational
Estimated Enrollment : 2002 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official 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
Actual Study Start Date : June 2016
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility
Drug Information available for: Menotropins

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




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   19 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Fertility clinics
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02835469


Contacts
Contact: Clinical Development Support DK0-Disclosure@ferring.com

Locations
Korea, Republic of
CL Hospital (there may be other sites in this country) Recruiting
Gwangju, Korea, Republic of
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals

Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02835469     History of Changes
Other Study ID Numbers: 000258
First Posted: July 18, 2016    Key Record Dates
Last Update Posted: May 21, 2018
Last Verified: May 2018

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Menotropins
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs