Infertility Clinical Trial
Verified date | April 2016 |
Source | National and Kapodistrian University of Athens |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 140 |
Est. completion date | August 2017 |
Est. primary completion date | July 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 36 Years |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
Greece | 3rd Department of Obstetrics and Gynecology, Assisted Reproduction Unit | Athens | Chaidari |
Greece | Attikon University Hospital | Athens | Chaidari |
Lead Sponsor | Collaborator |
---|---|
National and Kapodistrian University of Athens |
Greece,
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 Endoc — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | no of oocytes (>2 between groups) | at egg recovery, through study completion, an average of 2 years | ||
Secondary | Clinical pregnancy rate cancellation rate miscarriage rate ectopic pregnancy rate | The presence of fetal heart at transvaginal ultrasound at 6+2 gestational weeks | 3 weeks after embryo transfer | |
Secondary | Ongoing pregnancy rate | The presence of fetal heart at ultrasound after 12 gestational weeks | 12 weeks after embryo transfer | |
Secondary | miscarriage rate | through study completion, an average of 2 years | ||
Secondary | live birth rate | through study completion, an average of 2 years |
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