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Trial record 5 of 415 for:    Gonadotrophin, Chorionic AND Choriogonadotropin Alfa

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

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ClinicalTrials.gov Identifier: NCT02449889
Recruitment Status : Completed
First Posted : May 20, 2015
Results First Posted : June 10, 2019
Last Update Posted : June 26, 2019
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Infertility Drug: highly purified human chorionic gonadotropin Drug: recombinant human chorionic gonadotropin Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 176 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Study Start Date : April 2016
Actual Primary Completion Date : July 9, 2017
Actual Study Completion Date : March 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: HP-hCG IM
highly purified human chorionic gonadotropin, intramuscularly (IM)
Drug: highly purified human chorionic gonadotropin
Other Names:
  • CHORAPUR
  • BREVACTID

Experimental: HP-hCG SC
highly purified human chorionic gonadotropin, subcutaneously (SC)
Drug: highly purified human chorionic gonadotropin
Other Names:
  • CHORAPUR
  • BREVACTID

Active Comparator: rhCG
recombinant human chorionic gonadotropin
Drug: recombinant human chorionic gonadotropin
Other Names:
  • OVIDREL
  • OVITRELLE




Primary Outcome Measures :
  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 Outcome Measures :
  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]).



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Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02449889


Locations
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Brazil
Instituto Ideia Fértil de Saúde Reproductive (there may be other sites in this country)
São Paulo, Brazil
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
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Study Director: Clinical Development Support Ferring Pharmaceuticals
  Study Documents (Full-Text)

Documents provided by Ferring Pharmaceuticals:
Study Protocol  [PDF] January 30, 2015
Statistical Analysis Plan  [PDF] February 11, 2016


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Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02449889     History of Changes
Other Study ID Numbers: 000191
First Posted: May 20, 2015    Key Record Dates
Results First Posted: June 10, 2019
Last Update Posted: June 26, 2019
Last Verified: June 2019
Additional relevant MeSH terms:
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Infertility
Genital Diseases, Male
Genital Diseases, Female
Chorionic Gonadotropin
Reproductive Control Agents
Physiological Effects of Drugs