Back to resultsFrozen Embryo Transfer (FET) in Natural Cycles or in Natural Cycles Controlled by Human Chorionic Gonadotropin (hCG) Administration (FRET)
Primary Purpose
Infertility
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
HCG
Sponsored by
About this trial
This is an interventional treatment trial for Infertility focused on measuring natural cycle, FET, spontaneous LH pic, HCG
Eligibility Criteria
Inclusion Criteria:
- age <40
- BMI:18-29Kg/m2
- day 3 embryo transfers
- previously IVF or ICSI
Exclusion Criteria:
- irregular cycles
- oocyte donation cycles
Sites / Locations
- Centre of Reproductive Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
1
2
Arm Description
HCG GROUP
LH pick
Outcomes
Primary Outcome Measures
Implantation rate
Secondary Outcome Measures
Ongoing pregnancy rate
Full Information
NCT ID
NCT00809107
First Posted
December 16, 2008
Last Updated
February 18, 2009
Sponsor
Universitair Ziekenhuis Brussel
1. Study Identification
Unique Protocol Identification Number
NCT00809107
Brief Title
Frozen Embryo Transfer (FET) in Natural Cycles or in Natural Cycles Controlled by Human Chorionic Gonadotropin (hCG) Administration
Acronym
FRET
Official Title
Cryopreserved-Thawed Embryo Transfer in Natural Cycle or in Natural Cycles Controlled by External Administration of hCG: a Prospective Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
January 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Universitair Ziekenhuis Brussel
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The rational of the study is to assess the implantation, pregnancy and live birth rates after the transfer of frozen- thawed embryos in natural cycles with spontaneous Luteinizing Hormone (LH)/Progesterone rise or in natural cycles controlled by human chorionic gonadotropin (hCG) for final oocyte maturation and ovulation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
natural cycle, FET, spontaneous LH pic, HCG
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
HCG GROUP
Arm Title
2
Arm Type
No Intervention
Arm Description
LH pick
Intervention Type
Drug
Intervention Name(s)
HCG
Other Intervention Name(s)
pregnyl
Intervention Description
5000IU
Primary Outcome Measure Information:
Title
Implantation rate
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Ongoing pregnancy rate
Time Frame
2 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
age <40
BMI:18-29Kg/m2
day 3 embryo transfers
previously IVF or ICSI
Exclusion Criteria:
irregular cycles
oocyte donation cycles
Facility Information:
Facility Name
Centre of Reproductive Medicine
City
Brussel
ZIP/Postal Code
1090
Country
Belgium
12. IPD Sharing Statement
Citations:
PubMed Identifier
16500326
Citation
Gelbaya TA, Nardo LG, Hunter HR, Fitzgerald CT, Horne G, Pease EE, Brison DR, Lieberman BA. Cryopreserved-thawed embryo transfer in natural or down-regulated hormonally controlled cycles: a retrospective study. Fertil Steril. 2006 Mar;85(3):603-9. doi: 10.1016/j.fertnstert.2005.09.015.
Results Reference
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Frozen Embryo Transfer (FET) in Natural Cycles or in Natural Cycles Controlled by Human Chorionic Gonadotropin (hCG) Administration
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