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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01319695

Enrollment

140

Registered

2011-03-22

Start date

2011-01-31

Completion date

2017-08-31

Last updated

2021-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility

Keywords

corifollitropin alfa, FSH ovarian stimulation, IVF

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.

Interventions

DRUGcorifollitropin alfa

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

DRUGrecombinant follicle stimulating hormone (FSH)

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 36 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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	—

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026