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Completed

NCT Number: NCT02449889

A Randomised Trial Using Highly Purified Human Chorionic Gonadotropin (HP-hCG) and Recombinant Human Chorionic Gonadotropin (rhCG) in Women Undergoing Controlled Ovarian Stimulation

This trial is investigating the efficacy and safety of highly purified human chorionic gonadotropin (HP-hCG) and recombinant human chorionic gonadotropin (rhCG) for triggering of final follicular maturation in women undergoing controlled ovarian stimulation

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

18 year–39 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Instituto Ideia Fértil de Saúde Reproductive (there may be other sites in this country)

São Paulo, Brazil

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Pre-menopausal females between the ages of 18 and 39 years
  • Documented history of infertility
  • Body mass index (BMI) between 17.5 and 32.0 kg/m2
  • Regular menstrual cycles

Exclusion criteria

  • Known endometriosis stage III and IV
  • Known polycystic ovarian syndrome (PCOS)
  • History of recurrent miscarriage
  • History of more than three previous controlled ovarian stimulation cycles

Treatment and study plan

highly purified human chorionic gonadotropin

Drug

Other names: CHORAPUR, BREVACTID

recombinant human chorionic gonadotropin

Drug

Other names: OVIDREL, OVITRELLE

Primary outcomes

  1. Number of Oocytes Retrieved

    Time frame: Approximately 36 hours after hCG administration

    Oocyte retrieval took place 36 h (±2h) after hCG administration. At oocyte retrieval the number of oocytes retrieved was recorded.

Secondary outcomes

  1. Number of Metaphase II (MII) Oocytes

    Time frame: Prior to insemination (within 6 hours after oocyte retrieval)

    Only applicable for insemination using intracytoplasmic sperm injection (ICSI). The MII oocytes were counted prior to insemination.

  2. Number of Fertilized (2 Pronuclei (2PN)) Oocytes

    Time frame: One day after oocyte retrieval

    Fertilization was assessed by counting the number of pronuclei, which was recorded as 0, 1, 2 or >2. Correct fertilization was defined as oocytes with 2PN.

  3. Positive β Unit of Human Chorionic Gonadotropin (βhCG) Rate

    Time frame: 13-15 days after transfer

    Defined as percentage of subjects with positive beta hCG. A positive β hCG was confirmed by a blood test obtained 13-15 days after transfer.

  4. Clinical Pregnancy Rate

    Time frame: 5-6 weeks after transfer

    Defined as percentage of subjects with clinical pregnancy. Clinical pregnancy was defined as at least one gestational sac 5-6 weeks after transfer.

  5. Frequency of Adverse Events (AEs)

    Time frame: AEs were collected from signing informed consent until end of trial visit = maximum period approximately 5 months. However, only TEAEs are presented

    The number of treatment-emergent AEs (TEAEs) in each treatment group will be presented.

  6. Intensity of AEs

    Time frame: AEs were collected from signing informed consent until end of trial visit = maximum period approximately 5 months. However, only TEAEs are presented.

    The intensity of an TEAE would be classified using the following 3-point scale: mild (awareness of signs or symptoms, but no disruption of usual activity), moderate (event sufficient to affect usual activity [disturbing]) or severe (inability to work or perform usual activities [unacceptable]).

Sponsors and collaborators

Lead sponsor

Ferring Pharmaceuticals

Industry

Registry information

Official study title

A Randomised, Controlled, Assessor-blind, Parallel Groups, Multicentre Trial Comparing the Efficacy and Safety of Highly Purified Human Chorionic Gonadotropin (HP-hCG) and Recombinant Human Chorionic Gonadotropin (rhCG) for Triggering of Final Follicular Maturation in Women Undergoing Controlled Ovarian Stimulation

Acronym: FASHION

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
May 20, 2015
Registry last updated
Jun 26, 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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