Back to resultsCorifollitropin Alfa Versus Recombinant Follicle Stimulating Hormone (FSH) in Ovarian Stimulation of Women Undergoing in Vitro Fertilisation
Primary Purpose
Infertility
Status
Completed
Phase
Phase 1
Locations
Greece
Study Type
Interventional
Intervention
corifollitropin alfa
recombinant follicle stimulating hormone (FSH)
Sponsored by
About this trial
This is an interventional treatment trial for Infertility focused on measuring corifollitropin alfa, FSH ovarian stimulation, IVF
Eligibility Criteria
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)
Sites / Locations
- 3rd Department of Obstetrics and Gynecology, Assisted Reproduction Unit
- Attikon University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
corifollitropin alfa
recombinant follicle stimulating hormone (FSH)
Arm Description
150-300 IU of FSH for ovarian stimulation in women undergoing IVF
Outcomes
Primary Outcome Measures
no of oocytes (>2 between groups)
Secondary Outcome Measures
Clinical pregnancy rate cancellation rate miscarriage rate ectopic pregnancy rate
The presence of fetal heart at transvaginal ultrasound at 6+2 gestational weeks
Ongoing pregnancy rate
The presence of fetal heart at ultrasound after 12 gestational weeks
miscarriage rate
live birth rate
Full Information
NCT ID
NCT01319695
First Posted
March 8, 2011
Last Updated
March 15, 2021
Sponsor
National and Kapodistrian University of Athens
1. Study Identification
Unique Protocol Identification Number
NCT01319695
Brief Title
Corifollitropin Alfa Versus Recombinant Follicle Stimulating Hormone (FSH) in Ovarian Stimulation of Women Undergoing in Vitro Fertilisation
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
August 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National and Kapodistrian University of Athens
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
corifollitropin alfa, FSH ovarian stimulation, IVF
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
140 (Actual)
8. Arms, Groups, and Interventions
Arm Title
corifollitropin alfa
Arm Type
Experimental
Arm Title
recombinant follicle stimulating hormone (FSH)
Arm Type
Active Comparator
Arm Description
150-300 IU of FSH for ovarian stimulation in women undergoing IVF
Intervention Type
Drug
Intervention Name(s)
corifollitropin alfa
Intervention Description
100 microg for a group of women weighing <or=60 kg and 150 microg for a group of women weighing >60 kg
Intervention Type
Drug
Intervention Name(s)
recombinant follicle stimulating hormone (FSH)
Intervention Description
150-300 IU of the drug daily from day 2 of the menstrual cycle until more than 2 follicles are >18mm
Primary Outcome Measure Information:
Title
no of oocytes (>2 between groups)
Time Frame
at egg recovery, through study completion, an average of 2 years
Secondary Outcome Measure Information:
Title
Clinical pregnancy rate cancellation rate miscarriage rate ectopic pregnancy rate
Description
The presence of fetal heart at transvaginal ultrasound at 6+2 gestational weeks
Time Frame
3 weeks after embryo transfer
Title
Ongoing pregnancy rate
Description
The presence of fetal heart at ultrasound after 12 gestational weeks
Time Frame
12 weeks after embryo transfer
Title
miscarriage rate
Time Frame
through study completion, an average of 2 years
Title
live birth rate
Time Frame
through study completion, an average of 2 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
36 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Facility Information:
Facility Name
3rd Department of Obstetrics and Gynecology, Assisted Reproduction Unit
City
Athens
State/Province
Chaidari
ZIP/Postal Code
12462
Country
Greece
Facility Name
Attikon University Hospital
City
Athens
State/Province
Chaidari
ZIP/Postal Code
12642
Country
Greece
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
We will be happy to share the data
Citations:
PubMed Identifier
28508691
Citation
Siristatidis C, Dafopoulos K, Christoforidis N, Anifandis G, Pergialiotis V, Papantoniou N. Corifollitropin alfa compared with follitropin beta in GnRH-antagonist ovarian stimulation protocols in an unselected population undergoing IVF/ICSI. Gynecol Endocrinol. 2017 Dec;33(12):968-971. doi: 10.1080/09513590.2017.1323203. Epub 2017 May 16.
Results Reference
result
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Corifollitropin Alfa Versus Recombinant Follicle Stimulating Hormone (FSH) in Ovarian Stimulation of Women Undergoing in Vitro Fertilisation
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