Prospective Observational Study of Peri-implantation Serum hCG Levels

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.

Study Overview

• Status: Completed
• Conditions: Infertility

Detailed Description

The current study seeks to examine the effect of the timing of implantation (as indicated by the first increase in serum hCG level) on the viability of pregnancies and to determine if such effect of timing differs between fresh embryo transfers and frozen-thawed embryos transfers. In this case, the timing of implantation will be measured through serum hCG analysis on days 3, 4, 5, and 7 after blastocyst transfer.

• Study Type: Observational
• Enrollment (Actual): 451

Contacts and Locations

Study Locations

• United States
  • Nevada
    • Las Vegas, Nevada, United States, 89117
      • Fertility center of Las Vegas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

IVF patients

Description

Inclusion Criteria:

• IVF patients (adults) who received blastocyst transfer

Exclusion Criteria:

• Those patients using different laboratories

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Fresh embryo transfers; Patients who received fresh blastocyst transfer
Thawed embryo transfers; Patients who received transfers of frozen/thawed embryos

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ongoing pregnancy	Fetal heart motion at 10 weeks gestation.	10 weeks gestation

Collaborators and Investigators

• Sponsor: Bruce Shapiro M.D.

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: August 17, 2010
• First Submitted That Met QC Criteria: August 17, 2010
• First Posted (Estimate): August 19, 2010

Study Record Updates

• Last Update Posted (Estimate): October 15, 2012
• Last Update Submitted That Met QC Criteria: October 12, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: SAIRB 10-0007