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

National and Kapodistrian University of Athens

Status and phase: Completed; Phase 2; Phase 1

Conditions: Infertility

Treatments: Drug: corifollitropin alfa; Drug: recombinant follicle stimulating hormone (FSH)

Study type: Interventional

Funder types: Other

Identifiers

NCT01319695

1234560

Details and patient eligibility

About

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.

Enrollment: 140 patients

Sex: Female

Ages: 18 to 36 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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140 participants in 2 patient groups

corifollitropin alfa

Experimental group

Treatment:

Drug: corifollitropin alfa

recombinant follicle stimulating hormone (FSH)

Active Comparator group

Description:

150-300 IU of FSH for ovarian stimulation in women undergoing IVF

Treatment:

Drug: recombinant follicle stimulating hormone (FSH)