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

October 8, 2010 updated by: Fertility Center of Las Vegas
This study tests the hypothesis that controlled ovarian stimulation impairs endometrial receptivity in normal responders.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 normal 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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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.
  • 8 to 15 antral follicles observed on ultrasound.

Exclusion Criteria:

  • Failure to follow the protocol.
  • Embryo biopsy.
  • Any prior IVF cycle(s).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Blastocyst transfer in PTEC cycle
Transfer of two blastocysts derived from thawed bipronuclear oocytes that were subject to post-thaw extended culture (PTEC).
Procedure: Embryo cryopreservation
Cohort cryopreserved as bipronuclear (2pn) oocytes, then thawed and cultured to the blastocyst stage before transfer to the uterus.
Active Comparator: Fresh blastocyst transfer.
Transfer of two fresh autologous blastocysts following controlled ovarian stimulation.
Procedure: Fresh blastocyst transfer
Fresh blastocyst transfer following cycle of controlled ovarian stimulation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical pregnancy (fetal heartbeat observed on ultrasound at 7 weeks gestation)
Time Frame: 7 weeks gestation
7 weeks gestation

Secondary Outcome Measures

Outcome Measure
Time Frame
Ongoing pregnancy at 10 weeks gestation
Time Frame: 10 weeks gestation
10 weeks gestation
Implantation rate (ratio of the number of fetal heart tones to the number of transferred blastocysts)
Time Frame: 7 weeks gestation
7 weeks gestation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fertility Center of Las Vegas

Collaborators

Ferring Pharmaceuticals

Investigators

  • Principal Investigator: Bruce Shapiro, M.D., Ph.D., Fertility center of Las Vegas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

August 19, 2009

First Submitted That Met QC Criteria

August 20, 2009

First Posted (Estimate)

August 21, 2009

Study Record Updates

Last Update Posted (Estimate)

October 13, 2010

Last Update Submitted That Met QC Criteria

October 8, 2010

Last Verified

October 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAIRB 07-0014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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