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Completed

NCT Number: NCT01426386

A Dose-response Trial Using rFSH FE 999049 in Women Undergoing IVF/ICSI Treatment

This trial investigates the effects of several doses of FE 999049 in women undergoing IVF/ICSI (in-vitro fertilisation/intracytoplasmic sperm injection) treatment.

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

18 year–37 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

UZ Brussel, Brussels, Belgium

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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 (in-vitro fertilisation) and/or ICSI (intracytoplasmic sperm injection) treatment
  • Women aged 18-37 years
  • Women with body mass index (BMI) of 18.5-32.0 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

Gonal - F

Drug

Primary outcomes

  1. Number of Oocytes Retrieved

    Time frame: Day of oocyte retrieval (up to Day 18 after start of stimulation)

Secondary outcomes

  1. Number and Size of Follicles During Stimulation

    Time frame: End of stimulation (up to 16 stimulation days)

    Follicular volume at end of stimulation

  2. Endocrine Profile

    Time frame: End of stimulation (up to 16 stimulation days)

    Estradiol at end of stimulation

  3. Total IMP Dose

    Time frame: End of stimulation (up to 16 stimulation days)

  4. Number of Fertilised Oocytes

    Time frame: Day 1 after insemination

    An oocyte with 2 pronuclei was regarded as correctly fertilised

  5. Number and Quality of Blastocysts on Day 5

    Time frame: Day 5 after oocyte retrieval

    Number of blastocysts (total and good-quality) on Day 5 are presented. A good-quality blastocyst was defined as a blastocyst of grade 3BB or higher

  6. Clinical Pregnancy With Fetal Heart Beat Rate

    Time frame: 5-6 weeks after transfer

    Clinical pregnancy with fetal heart beat was defined as at least one intrauterine gestational sac with fetal heart beat

  7. Frequency and Intensity of Adverse Events

    Time frame: From signing informed consent form until end of trial visit (up to 5 months)

Sponsors and collaborators

Lead sponsor

Ferring Pharmaceuticals

Industry

Registry information

Official study title

A Randomised, Controlled, Assessor-blind, Parallel Groups, Multi-national, Multi-centre Trial Assessing the Dose-response Relationship of FE 999049 in Controlled Ovarian Stimulation in Women Undergoing an ART Programme

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Aug 31, 2011
Registry last updated
Nov 17, 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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