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

NCT02835469 | Completed

• 1 other identifier: 000258
• Study Type: observational
• Target: 412
• Locations: 1 country
• Sites: 1

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

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

• Ongoing pregnancy rate

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

  10-11 weeks after embryo transfer

Secondary Outcomes (7)

• Mean Follicle Stimulating Hormone (FSH) level

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

• 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 endometrial thickness

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

• Follicular development

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

Study Arms (1)

Menopur® Multidose

Treatment according to routine clinical practice.

Drug: Menotrophin

Interventions

Menotrophin DRUG

Also known as: Menopur® Multidose

Menopur® Multidose

Eligibility Criteria

• Age: 19 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Fertility clinics

You may qualify if:

• Decision made to prescribe Menopur® multidose according to Summary of product characteristics
• The study cycle will be either
• st controlled ovarian stimulation cycle ever, or
• nd controlled ovarian stimulation cycle ever, or
• st 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

Study Sites (1)

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

Gwangju, South Korea

Location

MeSH Terms

Conditions

Infertility

Interventions

Menotropins

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropins, Pituitary; Gonadotropins; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormones, Anterior; Pituitary Hormones; Peptides; Amino Acids, Peptides, and Proteins; Biological Products; Complex Mixtures

Study Officials

• Clinical Development Support

  Ferring Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2016
• First Posted: July 18, 2016
• Study Start: June 1, 2016
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2019
• Last Updated: March 28, 2019

Record last verified: 2019-03

Locations

KR (1)