Correlation Between Oocyte and Embryo Mechanical Properties on Embryo Development and Clinical Pregnancy After In Vitro Fertilization (EMECH)

February 12, 2021 updated by: Stanford University

Measuring the Relationship Between Ooocyte and Embryo Mechanical Properties and Embryo Development After In Vitro Fertilization

The purpose of this study is to determine whether oocyte and embryo mechanical properties measured during in vitro fertilization can predict embryo development outcomes and clinical pregnancy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In the current practice of in vitro fertilization (IVF), clinicians often transfer multiple embryos to the patient at once in an effort to maximize chances of pregnancy. This practice results in a high rate of multiple births which increase the risks of complications for mothers and children.

The investigators in this study have developed a novel, noninvasive marker of embryo viability which is based on measuring embryo mechanical properties at the oocyte or the 1-cell stage. The investigators would like to test whether human oocyte or embryo mechanical properties are predictive of subsequent development, clinical pregnancy, and compare their predictive power to that of a morphological assessment (the current gold standard). Using this approach, clinicians could more confidently move toward single embryo transfer, provided more individualized counseling for patients undergoing oocyte cryopreservation, as well as improve pregnancy rates after IVF.

This is a pilot observational study. Although investigators will measure the mechanical properties of all participant oocytes and embryos, no prediction of embryo viability will be made, and there will be no intervention in choosing which embryos to transfer to participants. The data from this study will eventually be used to find a range of oocyte and embryo mechanical parameters which are predictive of high developmental potential, and will serve as the basis for an interventional study in the future.

Study Type

Observational

Enrollment (Actual)

119

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

  • China
      • Shenzhen, China
        • Shenzhen Army and Police Hospital--Reproductive Unit
  • Taiwan
      • Hsinchu, Taiwan
        • Taiwan IVF Group
  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University IVF clinic

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

21 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

All patients undergoing in vitro fertilization at the Stanford IVF clinic, the Shenzhen IVF clinic, or Taiwan IVF group are eligible.

Description

Inclusion Criteria:

  • Between the ages of 21 and 45
  • Undergoing intra-cytoplasmic sperm injection (ICSI) at Stanford Fertility, Shenzhen IVF clinic, or Taiwan IVF group between August 2015 and August 2018

Exclusion Criteria:

  • Using gestational carrier or donor eggs
  • Using cryopreserved eggs
  • Fewer than 5 oocytes collected

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Measurement Group
This group contains oocytes and embryos which have their mechanical properties (elasticity and viscosity) measured prior to fertilization (oocytes) or within 24 hours after fertilization (embryos). The investigators are calling this mechanical measurement the "EmbryoHug." All participants in the study will have half their embryos measured in this group. Outcomes will be evaluated after 6 days of embryo culture, at the time of pregnancy test, at 5-6 weeks, and at 8-10 weeks, and correlated with EmbryoHug parameters.
Procedure: EmbryoHug
An oocyte or embryo will be gently held by a micropipette, and a small inward pressure will be applied to the edge of the oocyte or embryo. The response of the embryo to this pulling force will allow the investigators to measure its stiffness and viscosity. The term "micropipette aspiration" refers to the pressure applied to the edge of the embryo -- this procedure is not invasive and does not involve any sort of puncture or removal of material from the oocyte or embryo.
Other Names:
  • Micropipette Aspiration
  • Mechanical Measurement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical pregnancy (8-10 weeks)
Time Frame: 8-10 weeks
Positive result is determined by presence of intrauterine gestational sac and fetal heartbeat. Outcome will record number of gestational sacs with heartbeat present.
8-10 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blastocyst grade (Gardner scale)
Time Frame: 5-6 days
If the embryo reaches the blastocyst stage, its inner cell mass and trophectoderm will be graded according to Gardner's criteria. If no blastocyst is formed, that will be recorded as well.
5-6 days
Pregnancy test result (based on human chorionic gonadotropin (hCG) levels)
Time Frame: 2-3 weeks
Outcome will be recorded as either positive or negative.
2-3 weeks
Clinical pregnancy (5-6 weeks)
Time Frame: 5-6 weeks
Positive result is determined by presence of intrauterine gestational sac and fetal heartbeat (although sometimes the heartbeat does not show up for another week or two). Outcome will record number of gestational sacs.
5-6 weeks
Fertilization rate
Time Frame: 1 day
For oocytes measured, the fertilization of oocytes will be recorded.
1 day
Day 3 morphology
Time Frame: 3 days
For oocytes measured, the day 3 morphology of embryos will be recorded.
3 days

Collaborators and Investigators

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

Sponsor

Stanford University

Investigators

  • Principal Investigator: Valerie Baker, MD, Stanford University

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

August 1, 2015

Primary Completion (Actual)

June 30, 2018

Study Completion (Actual)

June 30, 2018

Study Registration Dates

First Submitted

August 4, 2015

First Submitted That Met QC Criteria

August 19, 2015

First Posted (Estimate)

August 21, 2015

Study Record Updates

Last Update Posted (Actual)

February 16, 2021

Last Update Submitted That Met QC Criteria

February 12, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 31948

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Upon publication of study results, we may include de-identified participant data for people who wish to conduct their own analysis.

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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