NCT01184469

Brief Summary

The purpose of this study is to prospectively define a set of data suitable for developing models of pregnancy viability. Those models will be based on serum hCG concentration measured during the peri-implantation period in patients that received fresh embryo transfer and those that received transfer of frozen-thawed embryos, and to compare and contrast these models. This may reveal insights into differences between these types of IVF cycles.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
451

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2010

Geographic Reach
1 country

1 active site

Status
completed

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, 2010

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

August 17, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 19, 2010

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

October 15, 2012

Status Verified

October 1, 2012

Enrollment Period

1.6 years

First QC Date

August 17, 2010

Last Update Submit

October 12, 2012

Conditions

Outcome Measures

Primary Outcomes (1)

  • Ongoing pregnancy

    Fetal heart motion at 10 weeks gestation.

    10 weeks gestation

Study Arms (2)

Fresh embryo transfers

Patients who received fresh blastocyst transfer

Thawed embryo transfers

Patients who received transfers of frozen/thawed embryos

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

IVF patients

You may qualify if:

  • IVF patients (adults) who received blastocyst transfer

You may not qualify if:

  • Those patients using different laboratories

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fertility Center of Las Vegas

Las Vegas, Nevada, 89117, United States

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Medica Director

Study Record Dates

First Submitted

August 17, 2010

First Posted

August 19, 2010

Study Start

August 1, 2010

Primary Completion

March 1, 2012

Study Completion

May 1, 2012

Last Updated

October 15, 2012

Record last verified: 2012-10

Locations