Comparison of Transfers of Fresh and Thawed Embryos in High Responder Patients
1 other identifier
interventional
100
1 country
1
Brief Summary
This study tests the hypothesis that controlled ovarian stimulation impairs endometrial receptivity in high responders.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2007
Typical duration for not_applicable
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
July 1, 2007
CompletedFirst Submitted
Initial submission to the registry
August 19, 2009
CompletedFirst Posted
Study publicly available on registry
August 21, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedJuly 13, 2010
July 1, 2010
3 years
August 19, 2009
July 12, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical pregnancy (fetal heartbeat observed on ultrasound at 7 weeks gestation)
7 weeks gestation
Secondary Outcomes (2)
Ongoing pregnancy at 10 weeks gestation
10 weeks
Implantation rate (ratio of the number of fetal heart tones to the number of transferred blastocysts)
7 weeks
Study Arms (2)
Blastocyst transfer in PTEC cycle
EXPERIMENTALTransfer of two blastocysts derived from thawed bipronuclear oocytes that were subject to post-thaw extended culture (PTEC).
Fresh blastocyst transfer
ACTIVE COMPARATORTransfer of two fresh autologous blastocysts following controlled ovarian stimulation.
Interventions
Cohort cryopreserved as bipronuclear (2pn) oocytes, then thawed and cultured to the blastocyst stage before transfer to the uterus.
Fresh blastocyst transfer following cycle of controlled ovarian stimulation.
Eligibility Criteria
You may qualify if:
- Female patient 18 to 40 years of age seeking their first IVF treatment.
- Cycle day 3 FSH less than 10.0 IU/l.
- More than 15 antral follicles observed on ultrasound.
You may not qualify if:
- Failure to follow the protocol.
- Embryo biopsy.
- Any prior IVF cycle(s).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fertility Center of Las Vegaslead
- Schering-Ploughcollaborator
Study Sites (1)
Fertility Center of Las Vegas
Las Vegas, Nevada, 89117, United States
Related Publications (3)
Zaat T, Zagers M, Mol F, Goddijn M, van Wely M, Mastenbroek S. Fresh versus frozen embryo transfers in assisted reproduction. Cochrane Database Syst Rev. 2021 Feb 4;2(2):CD011184. doi: 10.1002/14651858.CD011184.pub3.
PMID: 33539543DERIVEDShapiro BS, Daneshmand ST, Bedient CE, Garner FC. Comparison of birth weights in patients randomly assigned to fresh or frozen-thawed embryo transfer. Fertil Steril. 2016 Aug;106(2):317-21. doi: 10.1016/j.fertnstert.2016.03.049. Epub 2016 Jul 7.
PMID: 27397626DERIVEDShapiro BS, Daneshmand ST, Garner FC, Aguirre M, Hudson C, Thomas S. Evidence of impaired endometrial receptivity after ovarian stimulation for in vitro fertilization: a prospective randomized trial comparing fresh and frozen-thawed embryo transfers in high responders. Fertil Steril. 2011 Aug;96(2):516-8. doi: 10.1016/j.fertnstert.2011.02.059. Epub 2011 Jul 6.
PMID: 21737071DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bruce Shapiro, M.D., Ph.D.
Fertility Center of Las Vegas
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 19, 2009
First Posted
August 21, 2009
Study Start
July 1, 2007
Primary Completion
July 1, 2010
Study Completion
July 1, 2010
Last Updated
July 13, 2010
Record last verified: 2010-07