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OpenTrials
Completed

NCT Number: NCT02309671

A Dose-response Trial Using FE 999049 in Japanese Women Undergoing in Vitro Fertilisation (IVF) / Intracytoplasmic Sperm Injection (ICSI) Treatment

This trial investigates the effects of several doses of FE 999049 in Japanese women undergoing IVF/ICSI treatment.

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

20 year–39 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Investigational site (there may be other sites in this country)

Tokyo, Japan

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Women diagnosed with tubal infertility, unexplained infertility, infertility related to endometriosis stage I/II or with partners diagnosed with male factor infertility
  • Women eligible for IVF and/or ICSI treatment
  • Women aged 20-39 years
  • Women with body mass index (BMI) of 17.5-32.0 kg/m2

Exclusion criteria

  • Women with polycystic ovary syndrome (PCOS) associated with anovulation, endometriosis stage III/IV
  • Women with history of recurrent miscarriage
  • Women with contraindications to controlled ovarian stimulation with gonadotropins
  • Women with three or more controlled ovarian stimulation cycles

Treatment and study plan

FE 999049

Drug

Follitropin beta

Drug

Other names: FOLLISTIM

Primary outcomes

  1. Number of oocytes retrieved

    Time frame: End of stimulation (max 16 days after investigational medicinal product (IMP) start)

Secondary outcomes

  1. Number of follicles during stimulation

    Time frame: Up to 16 days

  2. Size of follicles during stimulation

    Time frame: Up to 16 days

  3. Endocrine profile measured by circulating levels of hormones

    Time frame: Up to 16 days

  4. Total IMP dose administered measured from first until last dose (end of stimulation)

    Time frame: Up to 16 days

  5. Embryo quality measured by fertilised oocytes and number and quality of embryos and blastocysts during culturing

    Time frame: 5 days (from oocyte retrieval to embryo transfer)

  6. Successful pregnancy rate

    Time frame: 5-6 weeks after transfer

  7. Frequency of adverse events

    Time frame: From signing informed consent form until end of trial visit = 8-9 weeks

  8. Intensity of adverse events

    Time frame: From signing informed consent form until end of trial visit = 8-9 weeks

Sponsors and collaborators

Lead sponsor

Ferring Pharmaceuticals

Industry

Registry information

Official study title

A Randomised, Controlled, Assessor-blind, Parallel Groups, Multicentre Trial Assessing the Dose-response Relationship of FE 999049 in Controlled Ovarian Stimulation in Japanese Women Undergoing an Assisted Reproductive Technology Programme

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Dec 5, 2014
Registry last updated
Dec 14, 2020

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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