Replacement of Fresh Embryo Transfers (ETs) by Frozen Embryo Transfers (FETs) Using Vitrification
Can Fresh Embryo Transfers be Replaced by Cryopreserved-thawed Embryo Transfers in Assisted Reproductive Cycles?
1 other identifier
interventional
500
1 country
1
Brief Summary
Cryopreservation of all embryos and transferring them subsequently in assisted reproductive technology (ART) cycles to improve outcome.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Aug 2008
1 active site
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
August 1, 2008
CompletedFirst Submitted
Initial submission to the registry
January 14, 2009
CompletedFirst Posted
Study publicly available on registry
January 15, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedJanuary 20, 2010
April 1, 2009
6 months
January 14, 2009
January 19, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
implantation rate
4 weeks
Secondary Outcomes (1)
on going pregnancy rate
3 months
Study Arms (2)
frozen-embryo transfer
ACTIVE COMPARATORIn this group all embryos are cryopreserved and two months later embryo transfer will perform.
fresh embryo transfer
ACTIVE COMPARATORIn this arm fresh embryo transfers are performed on day 2 or 3.
Interventions
vitrification by Cryotop method
fresh embryo transfers
Daily administration of 500 µg subcutaneous buserelin from day 21 of menstrual cycle; reduce to 250 µg daily when ovarian suppression is confirmed.
gonadotropin stimulation with rFSH 150 IU/day from day 2 of menstrual cycle
hCG 10,000 IU is administered when at least 2 follicles reach a mean diameter of 18 mm.
Eligibility Criteria
You may qualify if:
- age \< 38
- normal day 3 FSH
- classified as high risk for OHSS
- has ≥ 15 follicles with a mean diameter ≥ 12 mm per each ovary
- E2 levels on the day of hCG administration \> 3000 pg/mL
- undergoing her first assisted reproduction treatment cycle
You may not qualify if:
- who does not have good-quality embryos appropriate for cryopreservation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
: Research and clinical center for infertility
Yazd, Yazd Province, 8916877391, Iran
Related Publications (1)
Aflatoonian A, Oskouian H, Ahmadi S, Oskouian L. Can fresh embryo transfers be replaced by cryopreserved-thawed embryo transfers in assisted reproductive cycles? A randomized controlled trial. J Assist Reprod Genet. 2010 Jul;27(7):357-63. doi: 10.1007/s10815-010-9412-9. Epub 2010 Apr 6.
PMID: 20373015DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
abbas aflatoonian, M.D.
Research and Clinical Center for Infertility
- PRINCIPAL INVESTIGATOR
homa oskouian, M.D.
Research and Clinical Center for Infertility
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 14, 2009
First Posted
January 15, 2009
Study Start
August 1, 2008
Primary Completion
February 1, 2009
Study Completion
December 1, 2009
Last Updated
January 20, 2010
Record last verified: 2009-04