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

NCT ID: NCT02530892

Last Updated: 2021-02-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 119 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2018-06-30

Brief Summary

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.

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.

Conditions

Infertility; Pregnancy, Multiple

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

EmbryoHug

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

Other Intervention Names

Micropipette Aspiration; Mechanical Measurement

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Valerie Baker, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University IVF clinic

Stanford, California, United States

Shenzhen Army and Police Hospital--Reproductive Unit

Shenzhen, , China

Taiwan IVF Group

Hsinchu, , Taiwan

Countries

United States; China; Taiwan

Other Identifiers

31948

Identifier Type: -

Identifier Source: org_study_id