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

Phase 2CompletedNCT01319695

National and Kapodistrian University of Athens140 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

140

Conditions

Infertility

Interventions

corifollitropin alfaDRUG

100 microg for a group of women weighing \<or=60 kg and 150 microg for a group of women weighing \>60 kg

recombinant follicle stimulating hormone (FSH)DRUG

150-300 IU of the drug daily from day 2 of the menstrual cycle until more than 2 follicles are \>18mm

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 36 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (2)

3rd Department of Obstetrics and Gynecology, Assisted Reproduction Unit

Athens, Chaidari, Greece

Attikon University Hospital

Athens, Chaidari, Greece

Outcomes

Primary Outcomes

no of oocytes (>2 between groups)

Time frame: at egg recovery, through study completion, an average of 2 years

Secondary Outcomes

Clinical pregnancy rate cancellation rate miscarriage rate ectopic pregnancy rate

The presence of fetal heart at transvaginal ultrasound at 6+2 gestational weeks

Time frame: 3 weeks after embryo transfer

Ongoing pregnancy rate

The presence of fetal heart at ultrasound after 12 gestational weeks

Time frame: 12 weeks after embryo transfer

miscarriage rate

Time frame: through study completion, an average of 2 years

live birth rate

Time frame: through study completion, an average of 2 years

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.