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NCT Number: NCT01319695

Corifollitropin Alfa Versus Recombinant Follicle Stimulating Hormone (FSH) in Ovarian Stimulation of Women Undergoing in Vitro Fertilisation

The use of corifollitropin alfa is superior in terms of pregnancy outcome parameters as compared to recombinant follicle stimulating hormone (FSH) during ovarian stimulation protocols in women undergoing in vitro fertilisation.

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

18 year–36 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

3rd Department of Obstetrics and Gynecology, Assisted Reproduction Unit, Athens, Chaidari, Greece

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Women aged 18-36 years old with a body weight of more than 60 kg up to 90 kg
  • BMI of 18-32 kg/m2
  • Menstrual cycle length of 23-35 days
  • An indication for controlled ovarian stimulation for IVF or ICSI

Exclusion criteria

  • history of an endocrine abnormality
  • abnormal outcome of blood biochemistry or hematology
  • abnormal cervical smear
  • chronic disease
  • uterine pathology that interfering with the COS treatment (e.g. fibroids ≥ 5 cm)

Treatment and study plan

Corifollitropin alfa

Drug

100 microg for a group of women weighing <or=60 kg and 150 microg for a group of women weighing >60 kg

recombinant follicle stimulating hormone (FSH)

Drug

150-300 IU of the drug daily from day 2 of the menstrual cycle until more than 2 follicles are >18mm

Primary outcomes

  1. no of oocytes (>2 between groups)

    Time frame: at egg recovery, through study completion, an average of 2 years

Secondary outcomes

  1. Clinical pregnancy rate cancellation rate miscarriage rate ectopic pregnancy rate

    Time frame: 3 weeks after embryo transfer

    The presence of fetal heart at transvaginal ultrasound at 6+2 gestational weeks

  2. Ongoing pregnancy rate

    Time frame: 12 weeks after embryo transfer

    The presence of fetal heart at ultrasound after 12 gestational weeks

  3. miscarriage rate

    Time frame: through study completion, an average of 2 years

  4. live birth rate

    Time frame: through study completion, an average of 2 years

Sponsors and collaborators

Lead sponsor

National and Kapodistrian University of Athens

Other

Registry information

Important dates

Study start
2011
Primary completion
2016
Study completion
2017
First posted
Mar 22, 2011
Registry last updated
Mar 17, 2021

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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