Comparison of Transfers of Fresh and Thawed Embryos in Normal Responder Patients
Primary Purpose
Infertility
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Embryo cryopreservation
Fresh blastocyst transfer
Sponsored by
About this trial
This is an interventional treatment trial for Infertility focused on measuring Blastocyst transfer, endometrial receptivity, IVF, in vitro fertilization, embryo cryopreservation
Eligibility Criteria
Inclusion Criteria:
- Female patient 18 to 40 years of age seeking their first IVF treatment.
- Cycle day 3 FSH less than 10.0 IU/l.
- 8 to 15 antral follicles observed on ultrasound.
Exclusion Criteria:
- Failure to follow the protocol.
- Embryo biopsy.
- Any prior IVF cycle(s).
Sites / Locations
- Fertility Center of Las Vegas
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Blastocyst transfer in PTEC cycle
Fresh blastocyst transfer.
Arm Description
Transfer of two blastocysts derived from thawed bipronuclear oocytes that were subject to post-thaw extended culture (PTEC).
Transfer of two fresh autologous blastocysts following controlled ovarian stimulation.
Outcomes
Primary Outcome Measures
Clinical pregnancy (fetal heartbeat observed on ultrasound at 7 weeks gestation)
Secondary Outcome Measures
Ongoing pregnancy at 10 weeks gestation
Implantation rate (ratio of the number of fetal heart tones to the number of transferred blastocysts)
Full Information
NCT ID
NCT00963625
First Posted
August 19, 2009
Last Updated
October 8, 2010
Sponsor
Fertility Center of Las Vegas
Collaborators
Ferring Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00963625
Brief Title
Comparison of Transfers of Fresh and Thawed Embryos in Normal Responder Patients
Official Title
Comparison of Transfers of Fresh and Thawed Embryos in Normal Responder Patients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2010
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Fertility Center of Las Vegas
Collaborators
Ferring Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study tests the hypothesis that controlled ovarian stimulation impairs endometrial receptivity in normal responders.
Detailed Description
The purpose of this study is to determine if blastocyst transfers in cycles of post-thaw extended culture (PTEC) have different efficacy than transfers of fresh blastocysts in patients with expected normal response to ovarian stimulation.
Multiple studies have found altered endometrial histology and gene expression following controlled ovarian stimulation.
PTEC cycles require cryopreservation of the entire 2pn oocyte cohort in the prior cycle. Once thawed, the embryos are cultured to the blastocyst stage before transfer.
In typical cycles using frozen-thawed embryos, many thawed embryos that appear to survive do not actually resume and continue development. PTEC ensures the transfer of embryos that resumed development and continued developing at least to the blastocyst stage (4-5 days post-thaw).
The viability of a blastocyst in a PTEC cycle has been shown to be on par with that of a fresh blastocyst. Therefore, comparing outcomes of blastocyst transfers in PTEC cycles with that in fresh autologous cycles allows the potential endometrial impact of controlled ovarian stimulation to be assessed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
Blastocyst transfer, endometrial receptivity, IVF, in vitro fertilization, embryo cryopreservation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Blastocyst transfer in PTEC cycle
Arm Type
Experimental
Arm Description
Transfer of two blastocysts derived from thawed bipronuclear oocytes that were subject to post-thaw extended culture (PTEC).
Arm Title
Fresh blastocyst transfer.
Arm Type
Active Comparator
Arm Description
Transfer of two fresh autologous blastocysts following controlled ovarian stimulation.
Intervention Type
Procedure
Intervention Name(s)
Embryo cryopreservation
Intervention Description
Cohort cryopreserved as bipronuclear (2pn) oocytes, then thawed and cultured to the blastocyst stage before transfer to the uterus.
Intervention Type
Procedure
Intervention Name(s)
Fresh blastocyst transfer
Intervention Description
Fresh blastocyst transfer following cycle of controlled ovarian stimulation.
Primary Outcome Measure Information:
Title
Clinical pregnancy (fetal heartbeat observed on ultrasound at 7 weeks gestation)
Time Frame
7 weeks gestation
Secondary Outcome Measure Information:
Title
Ongoing pregnancy at 10 weeks gestation
Time Frame
10 weeks gestation
Title
Implantation rate (ratio of the number of fetal heart tones to the number of transferred blastocysts)
Time Frame
7 weeks gestation
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Female patient 18 to 40 years of age seeking their first IVF treatment.
Cycle day 3 FSH less than 10.0 IU/l.
8 to 15 antral follicles observed on ultrasound.
Exclusion Criteria:
Failure to follow the protocol.
Embryo biopsy.
Any prior IVF cycle(s).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruce Shapiro, M.D., Ph.D.
Organizational Affiliation
Fertility Center of Las Vegas
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fertility Center of Las Vegas
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89117
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
33539543
Citation
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.
Results Reference
derived
PubMed Identifier
27397626
Citation
Shapiro 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.
Results Reference
derived
PubMed Identifier
21737072
Citation
Shapiro 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 transfer in normal responders. Fertil Steril. 2011 Aug;96(2):344-8. doi: 10.1016/j.fertnstert.2011.05.050. Epub 2011 Jul 6.
Results Reference
derived
Learn more about this trial
Comparison of Transfers of Fresh and Thawed Embryos in Normal Responder Patients
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