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Completed

NCT Number: NCT02530892

Correlation Between Oocyte and Embryo Mechanical Properties on Embryo Development and Clinical Pregnancy 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.

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Key information

Age range

21 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Shenzhen Army and Police Hospital--Reproductive Unit, Shenzhen, China

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EmbryoHug

Procedure

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. Pregnancy test result (based on human chorionic gonadotropin (hCG) levels)

    Time frame: 2-3 weeks

    Outcome will be recorded as either positive or negative.

  3. 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.

  4. Fertilization rate

    Time frame: 1 day

    For oocytes measured, the fertilization of oocytes will be recorded.

  5. Day 3 morphology

    Time frame: 3 days

    For oocytes measured, the day 3 morphology of embryos will be recorded.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

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

Acronym: EMECH

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Aug 21, 2015
Registry last updated
Feb 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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