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Comparison of Transfers of Fresh and Thawed Embryos in High Responder Patients

Primary Purpose

Infertility

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Embryo cryopreservation
Fresh blastocyst transfer
Sponsored by
Fertility Center of Las Vegas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring IVF, in vitro fertilization, blastocyst transfer, endometrial receptivity, embryo cryopreservation

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. Female patient 18 to 40 years of age seeking their first IVF treatment.
  2. Cycle day 3 FSH less than 10.0 IU/l.
  3. More than 15 antral follicles observed on ultrasound.

Exclusion Criteria:

  1. Failure to follow the protocol.
  2. Embryo biopsy.
  3. 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

First Posted
August 19, 2009
Last Updated
July 12, 2010
Sponsor
Fertility Center of Las Vegas
Collaborators
Schering-Plough
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1. Study Identification

Unique Protocol Identification Number
NCT00963079
Brief Title
Comparison of Transfers of Fresh and Thawed Embryos in High Responder Patients
Official Title
Comparison of Transfers of Fresh and Thawed Embryos in High Responder Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Fertility Center of Las Vegas
Collaborators
Schering-Plough

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study tests the hypothesis that controlled ovarian stimulation impairs endometrial receptivity in high 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 high 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
IVF, in vitro fertilization, blastocyst transfer, endometrial receptivity, 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
Title
Implantation rate (ratio of the number of fetal heart tones to the number of transferred blastocysts)
Time Frame
7 weeks

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. More than 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
21737071
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 transfers in high responders. Fertil Steril. 2011 Aug;96(2):516-8. doi: 10.1016/j.fertnstert.2011.02.059. Epub 2011 Jul 6.
Results Reference
derived

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Comparison of Transfers of Fresh and Thawed Embryos in High Responder Patients

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