Back to resultsA Randomised Trial Using Highly Purified Human Chorionic Gonadotropin (HP-hCG) and Recombinant Human Chorionic Gonadotropin (rhCG) in Women Undergoing Controlled Ovarian Stimulation (FASHION)
Primary Purpose
Infertility
Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
highly purified human chorionic gonadotropin
recombinant human chorionic gonadotropin
Sponsored by
About this trial
This is an interventional treatment trial for Infertility
Eligibility 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
Sites / Locations
- Instituto Ideia Fértil de Saúde Reproductive (there may be other sites in this country)
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
HP-hCG IM
HP-hCG SC
rhCG
Arm Description
highly purified human chorionic gonadotropin, intramuscularly (IM)
highly purified human chorionic gonadotropin, subcutaneously (SC)
recombinant human chorionic gonadotropin
Outcomes
Primary Outcome Measures
Number of Oocytes Retrieved
Oocyte retrieval took place 36 h (±2h) after hCG administration. At oocyte retrieval the number of oocytes retrieved was recorded.
Secondary Outcome Measures
Number of Metaphase II (MII) Oocytes
Only applicable for insemination using intracytoplasmic sperm injection (ICSI). The MII oocytes were counted prior to insemination.
Number of Fertilized (2 Pronuclei (2PN)) Oocytes
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.
Positive β Unit of Human Chorionic Gonadotropin (βhCG) Rate
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.
Clinical Pregnancy Rate
Defined as percentage of subjects with clinical pregnancy. Clinical pregnancy was defined as at least one gestational sac 5-6 weeks after transfer.
Frequency of Adverse Events (AEs)
The number of treatment-emergent AEs (TEAEs) in each treatment group will be presented.
Intensity of AEs
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]).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02449889
Brief Title
A Randomised Trial Using Highly Purified Human Chorionic Gonadotropin (HP-hCG) and Recombinant Human Chorionic Gonadotropin (rhCG) in Women Undergoing Controlled Ovarian Stimulation
Acronym
FASHION
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 Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
July 9, 2017 (Actual)
Study Completion Date
March 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ferring Pharmaceuticals
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
176 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HP-hCG IM
Arm Type
Experimental
Arm Description
highly purified human chorionic gonadotropin, intramuscularly (IM)
Arm Title
HP-hCG SC
Arm Type
Experimental
Arm Description
highly purified human chorionic gonadotropin, subcutaneously (SC)
Arm Title
rhCG
Arm Type
Active Comparator
Arm Description
recombinant human chorionic gonadotropin
Intervention Type
Drug
Intervention Name(s)
highly purified human chorionic gonadotropin
Other Intervention Name(s)
CHORAPUR, BREVACTID
Intervention Type
Drug
Intervention Name(s)
recombinant human chorionic gonadotropin
Other Intervention Name(s)
OVIDREL, OVITRELLE
Primary Outcome Measure Information:
Title
Number of Oocytes Retrieved
Description
Oocyte retrieval took place 36 h (±2h) after hCG administration. At oocyte retrieval the number of oocytes retrieved was recorded.
Time Frame
Approximately 36 hours after hCG administration
Secondary Outcome Measure Information:
Title
Number of Metaphase II (MII) Oocytes
Description
Only applicable for insemination using intracytoplasmic sperm injection (ICSI). The MII oocytes were counted prior to insemination.
Time Frame
Prior to insemination (within 6 hours after oocyte retrieval)
Title
Number of Fertilized (2 Pronuclei (2PN)) Oocytes
Description
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.
Time Frame
One day after oocyte retrieval
Title
Positive β Unit of Human Chorionic Gonadotropin (βhCG) Rate
Description
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.
Time Frame
13-15 days after transfer
Title
Clinical Pregnancy Rate
Description
Defined as percentage of subjects with clinical pregnancy. Clinical pregnancy was defined as at least one gestational sac 5-6 weeks after transfer.
Time Frame
5-6 weeks after transfer
Title
Frequency of Adverse Events (AEs)
Description
The number of treatment-emergent AEs (TEAEs) in each treatment group will be presented.
Time Frame
AEs were collected from signing informed consent until end of trial visit = maximum period approximately 5 months. However, only TEAEs are presented
Title
Intensity of AEs
Description
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]).
Time Frame
AEs were collected from signing informed consent until end of trial visit = maximum period approximately 5 months. However, only TEAEs are presented.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Development Support
Organizational Affiliation
Ferring Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Instituto Ideia Fértil de Saúde Reproductive (there may be other sites in this country)
City
São Paulo
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
A Randomised Trial Using Highly Purified Human Chorionic Gonadotropin (HP-hCG) and Recombinant Human Chorionic Gonadotropin (rhCG) in Women Undergoing Controlled Ovarian Stimulation
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