Comparison of Transfers of Fresh and Thawed Embryos in Patients With Prior Failed Embryo Transfer Cycles

NCT ID: NCT00736177

Last Updated: 2014-04-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2009-08-31

Brief Summary

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This study seeks to determine if patients with a history of failed fresh embryo transfer(s) will have increased success rates with embryo cryopreservation and subsequent thawed embryo transfer when compared to fresh embryo transfer.

Detailed Description

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Implantation failure remains a significant problem in cycles of in vitro fertilization (IVF). Patients with a history of implantation failure in fresh autologous cycles have been shown have reduced chance of success in subsequent fresh autologous cycles. A potentially frequent cause of implantation failure is reduced endometrial receptivity following ovarian stimulation, perhaps due to the effects of supraphysiologic hormone levels on endometrial development. Therefore, such patients may have a greater chance of success if all of their embryos are cryopreserved for use in a subsequent cycle in which endometrial development can be more carefully controlled, absent the effects of ovarian stimulation. Therefore this study compares success rates in cycles of fresh embryo transfer and cycles with transfer of frozen-thawed embryos.

Conditions

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Infertility Subfertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control

Patients in the control group will undergo conventional IVF cycles with fresh blastocyst transfer.

Group Type ACTIVE_COMPARATOR

Fresh embryo transfer

Intervention Type PROCEDURE

Subjects in the Control group will receive fresh embryo transfer.

Test group

Patients in the Test group will have their embryos cryopreserved for transfer in a second cycle.

Group Type EXPERIMENTAL

Embryo cryopreservation

Intervention Type PROCEDURE

Subjects in the Test group will have their embryos cryopreserved for transfer in a subsequent cycle.

Interventions

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Embryo cryopreservation

Subjects in the Test group will have their embryos cryopreserved for transfer in a subsequent cycle.

Intervention Type PROCEDURE

Fresh embryo transfer

Subjects in the Control group will receive fresh embryo transfer.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Age 18 to 40 years
* Cycle day 3 FSH less than 10 IU/l
* At least 8 antral follicles
* At least one previous autologous embryo transfer cycle that did not result in ongoing pregnancy at 10 weeks.

Exclusion Criteria

* Embryo biopsy
* Any prior fresh embryo transfer that resulted in live birth
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Fertility Center of Las Vegas

INDUSTRY

Sponsor Role lead

Responsible Party

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Fertility Center of Las Vegas

Principal Investigators

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Bruce Shapiro, M.D.

Role: PRINCIPAL_INVESTIGATOR

Fertility Center of Las Vegas

Locations

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Fertility Center of Las Vegas

Las Vegas, Nevada, United States

Site Status

Countries

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United States

References

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Shapiro BS, Daneshmand ST, Garner FC, Aguirre M, Thomas S. Large blastocyst diameter, early blastulation, and low preovulatory serum progesterone are dominant predictors of clinical pregnancy in fresh autologous cycles. Fertil Steril. 2008 Aug;90(2):302-9. doi: 10.1016/j.fertnstert.2007.06.062. Epub 2007 Oct 1.

Reference Type BACKGROUND
PMID: 17905239 (View on PubMed)

Shapiro BS, Daneshmand ST, Garner FC, Aguirre M, Ross R. Contrasting patterns in in vitro fertilization pregnancy rates among fresh autologous, fresh oocyte donor, and cryopreserved cycles with the use of day 5 or day 6 blastocysts may reflect differences in embryo-endometrium synchrony. Fertil Steril. 2008 Jan;89(1):20-6. doi: 10.1016/j.fertnstert.2006.08.092. Epub 2007 Jan 16.

Reference Type BACKGROUND
PMID: 17224151 (View on PubMed)

Related Links

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http://www.fertilitycenterlv.com

Fertility Center of Las Vegas

Other Identifiers

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SAIRB-08-0012

Identifier Type: -

Identifier Source: org_study_id

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