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OpenTrials
Completed

NCT Number: NCT01969201

FSH in GnRH-AntagoniST Controlled Ovarian Hyperstimulation Cycles (FAST)

The purpose of the non-inferiority study is to evaluate the clinical efficacy and the safety of two different subcutaneous FSH preparations (Fostimon versus Gonal-F) for controlled ovarian hyperstimulation in a GnRH-antagonist cycle.

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Key information

Age range

18 year–38 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

UCL- Cliniques Universitaires Saint Luc, 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

  • Age: 18-38 years old;
  • BMI: 18-28 kg/m2;
  • Less than 3 previously completed IVF cycles;
  • Basal FSH <10 IU/L and E2 <80 pg/ml;
  • TSH < 2.5 mIU/L
  • >10 and <30 antral follicles 2-10 mm in size for both ovaries combined
  • AMH: >1 ng/ml (7.15 pmol/l) and <5.6 ng/ml (40.0 pmol/l)
  • Presence and adequate visualization of both ovaries;
  • Within 12 months of the beginning of the study, uterine cavity consistent with expected normal function as assessed through transvaginal ultrasound, hysterosalpingogram, sonohysterogram or hysteroscopic examination;

Exclusion criteria

  • Primary ovarian failure or women known as poor responders;
  • PCO and PCOS;
  • Severe OHSS in a previous COH cycle;
  • Uterine malformation that may impair the possibility to get pregnant;
  • Ovarian cysts >10 mm;
  • Hydrosalpinx that have not been surgically removed or ligated;
  • Endometriosis stage 3 or 4;
  • Oocyte donation;
  • Severe male factor;
  • Pathologies associated with any contraindication of being pregnant;
  • History of recurrent miscarriage (more than 3 previous miscarriages);
  • Hypersensitivity to the study medication;
  • Abnormal bleeding of undetermined origin;
  • Uncontrolled thyroid or adrenal dysfunction;
  • Neoplasias;
  • Severe impairment of renal and/or hepatic function.

Treatment and study plan

Urofollitrophin

Drug

Other names: human derived follicle stimulation hormone

Follitrophin alpha

Drug

Other names: Recombinant follicle stimulation hormone

Primary outcomes

  1. Clinical Pregnancy Rate

    Time frame: 8 weeks

    A clinical pregnancy is defined as a pregnancy showing ultrasound embryonic heart activity at 8 weeks of gestation;

Secondary outcomes

  1. Number of Follicles >16 mm on the Day of hCG Injection

    Time frame: 10-15 days after starting FSH stimulation

  2. Total Number of Oocytes Retrieved

    Time frame: end of treatment period, approximately 2 - 3 weeks.

  3. Fertilization Rate

    Time frame: end of treatment period, approximately 2 - 3 weeks

  4. Embryo Quality (Number of Top Quality Embryos Transferred Per Patient)

    Time frame: On culture day 3

    The embryo quality evaluation will be performed on culture day 3, just before embryo transfer and will consist in the assessment of blastomeres number and 2 embryo morphology parameters: degree of fragmentation and cell division aspect.

  5. Positive Serum Pregnancy Test Rate

    Time frame: 2 weeks after embryo transfer

    Two weeks after embryo transfer, a serum pregnancy test will be performed.

  6. Delivery Rate

    Time frame: 9 months

  7. Cumulative Pregnancy Rate

    Time frame: 2 years

    Patients who will not get pregnant during the study, will be allowed to perform a frozen embryo transfer. Cumulative pregnancy rate will include also pregnancies achieved after a frozen embryo transfer.

Sponsors and collaborators

Lead sponsor

IBSA Institut Biochimique SA

Industry

Registry information

Official study title

Randomised Clinical Trial Comparing Highly Purified FSH Formulation (Fostimon®) and Recombinant FSH (Gonal-F®) in GnRH-antagonist Controlled Ovarian Hyperstimulation Cycles.

Acronym: FAST

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Oct 25, 2013
Registry last updated
Oct 9, 2019

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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