NCT00736177

Brief Summary

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2008

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

August 13, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 15, 2008

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

April 9, 2014

Status Verified

February 1, 2009

Enrollment Period

1 year

First QC Date

August 13, 2008

Last Update Submit

April 8, 2014

Conditions

Keywords

IVFblastocyst transferendometriumembryo cryopreservation

Outcome Measures

Primary Outcomes (1)

  • Ongoing pregnancy with fetal heart motion

    10 weeks gestation

Study Arms (2)

Control

ACTIVE COMPARATOR

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

Procedure: Fresh embryo transfer

Test group

EXPERIMENTAL

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

Procedure: Embryo cryopreservation

Interventions

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

Test group

Subjects in the Control group will receive fresh embryo transfer.

Control

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Embryo biopsy
  • Any prior fresh embryo transfer that resulted in live birth

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fertility Center of Las Vegas

Las Vegas, Nevada, 89117, United States

Location

Related Publications (2)

  • 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.

    PMID: 17905239BACKGROUND
  • 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.

    PMID: 17224151BACKGROUND

Related Links

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Bruce Shapiro, M.D.

    Fertility Center of Las Vegas

    PRINCIPAL INVESTIGATOR
0

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 13, 2008

First Posted

August 15, 2008

Study Start

August 1, 2008

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

April 9, 2014

Record last verified: 2009-02

Locations