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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01319695
Recruitment Status : Completed
First Posted : March 22, 2011
Last Update Posted : March 17, 2021
Sponsor:
Information provided by (Responsible Party):
Siristatidis Charalampos, MD, PhD, National and Kapodistrian University of Athens

Study Description
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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.

Condition or disease Intervention/treatment Phase
Infertility Drug: corifollitropin alfa Drug: recombinant follicle stimulating hormone (FSH) Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Study Start Date : January 2011
Actual Primary Completion Date : July 2016
Actual Study Completion Date : August 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones

Arms and Interventions
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Arm Intervention/treatment
Experimental: corifollitropin alfa Drug: corifollitropin alfa
100 microg for a group of women weighing <or=60 kg and 150 microg for a group of women weighing >60 kg
Active Comparator: recombinant follicle stimulating hormone (FSH)
150-300 IU of FSH for ovarian stimulation in women undergoing IVF
 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


Outcome Measures
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Primary Outcome Measures :
  1. no of oocytes (>2 between groups) [ Time Frame: at egg recovery, through study completion, an average of 2 years ]

Secondary Outcome Measures :
  1. Clinical pregnancy rate cancellation rate miscarriage rate ectopic pregnancy rate [ Time Frame: 3 weeks after embryo transfer ]
    The presence of fetal heart at transvaginal ultrasound at 6+2 gestational weeks

  2. Ongoing pregnancy rate [ Time Frame: 12 weeks after embryo transfer ]
    The presence of fetal heart at ultrasound after 12 gestational weeks

  3. miscarriage rate [ Time Frame: through study completion, an average of 2 years ]
  4. live birth rate [ Time Frame: through study completion, an average of 2 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 36 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01319695


Locations
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Greece
3rd Department of Obstetrics and Gynecology, Assisted Reproduction Unit
Athens, Chaidari, Greece, 12462
Attikon University Hospital
Athens, Chaidari, Greece, 12642
Sponsors and Collaborators
National and Kapodistrian University of Athens
More Information
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Publications of Results:

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Responsible Party: Siristatidis Charalampos, MD, PhD, Assistant Professor, Director of the ARU, National and Kapodistrian University of Athens
ClinicalTrials.gov Identifier: NCT01319695    
Other Study ID Numbers: 1234560
First Posted: March 22, 2011    Key Record Dates
Last Update Posted: March 17, 2021
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: We will be happy to share the data
Keywords provided by Siristatidis Charalampos, MD, PhD, National and Kapodistrian University of Athens:
corifollitropin alfa
FSH ovarian stimulation
IVF
Additional relevant MeSH terms:
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Infertility
Genital Diseases
Urogenital Diseases
Hormones
 Follicle Stimulating Hormone
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs