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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2017-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Infertility

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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corifollitropin alfa

Group Type EXPERIMENTAL

corifollitropin alfa

Intervention Type DRUG

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)

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

Group Type ACTIVE_COMPARATOR

recombinant follicle stimulating hormone (FSH)

Intervention Type DRUG

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

Interventions

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corifollitropin alfa

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

Intervention Type DRUG

recombinant 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

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

36 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes