Corifollitropin Alfa Versus Recombinant Follicle Stimulating Hormone (FSH) in Ovarian Stimulation of Women Undergoing in Vitro Fertilisation

Phase 1

Completed

• Conditions: Infertility
• Interventions: Drug: corifollitropin alfa; Drug: recombinant follicle stimulating hormone (FSH)

• Registration Number: NCT01319695
• Lead Sponsor: National and Kapodistrian University of Athens

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-03-08
• Study First Submitted QC: 2011-03-21
• Study First Posted: 2011-03-22
• Status Verified: 2016-04
• Primary Completion: 2016-07
• Study Completion: 2017-08
• Last Update Submitted: 2021-03-15
• Last Update Posted: 2021-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 140

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
corifollitropin alfa	corifollitropin alfa	-
recombinant follicle stimulating hormone (FSH)	recombinant follicle stimulating hormone (FSH)	150-300 IU of FSH for ovarian stimulation in women undergoing IVF

Primary Outcome Measures

Name	Time	Method
no of oocytes (>2 between groups)	at egg recovery, through study completion, an average of 2 years

Secondary Outcome Measures

Name	Time	Method
Clinical pregnancy rate cancellation rate miscarriage rate ectopic pregnancy rate	3 weeks after embryo transfer	The presence of fetal heart at transvaginal ultrasound at 6+2 gestational weeks
Ongoing pregnancy rate	12 weeks after embryo transfer	The presence of fetal heart at ultrasound after 12 gestational weeks
miscarriage rate	through study completion, an average of 2 years
live birth rate	through study completion, an average of 2 years

Trial Locations

Locations (2)

3rd Department of Obstetrics and Gynecology, Assisted Reproduction Unit; 🇬🇷 Athens, Chaidari, Greece

Attikon University Hospital; 🇬🇷 Athens, Chaidari, Greece