Corifollitropin Alfa Versus Recombinant Follicle Stimulating Hormone (FSH) in Ovarian Stimulation of Women Undergoing in Vitro Fertilisation
1 other identifier
interventional
140
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jan 2011
Longer than P75 for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 8, 2011
CompletedFirst Posted
Study publicly available on registry
March 22, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2017
CompletedMarch 17, 2021
April 1, 2016
5.5 years
March 8, 2011
March 15, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
no of oocytes (>2 between groups)
at egg recovery, through study completion, an average of 2 years
Secondary Outcomes (4)
Clinical pregnancy rate cancellation rate miscarriage rate ectopic pregnancy rate
3 weeks after embryo transfer
Ongoing pregnancy rate
12 weeks after embryo transfer
miscarriage rate
through study completion, an average of 2 years
live birth rate
through study completion, an average of 2 years
Study Arms (2)
corifollitropin alfa
EXPERIMENTALrecombinant follicle stimulating hormone (FSH)
ACTIVE COMPARATOR150-300 IU of FSH for ovarian stimulation in women undergoing IVF
Interventions
100 microg for a group of women weighing \<or=60 kg and 150 microg for a group of women weighing \>60 kg
150-300 IU of the drug daily from day 2 of the menstrual cycle until more than 2 follicles are \>18mm
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
3rd Department of Obstetrics and Gynecology, Assisted Reproduction Unit
Athens, Chaidari, 12462, Greece
Attikon University Hospital
Athens, Chaidari, 12642, Greece
Related Publications (1)
Siristatidis C, Dafopoulos K, Christoforidis N, Anifandis G, Pergialiotis V, Papantoniou N. Corifollitropin alfa compared with follitropin beta in GnRH-antagonist ovarian stimulation protocols in an unselected population undergoing IVF/ICSI. Gynecol Endocrinol. 2017 Dec;33(12):968-971. doi: 10.1080/09513590.2017.1323203. Epub 2017 May 16.
PMID: 28508691RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor, Director of the ARU
Study Record Dates
First Submitted
March 8, 2011
First Posted
March 22, 2011
Study Start
January 1, 2011
Primary Completion
July 1, 2016
Study Completion
August 1, 2017
Last Updated
March 17, 2021
Record last verified: 2016-04