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

NCT02530892 | Completed

• 1 other identifier: 31948
• Study Type: observational
• Target: 119
• Locations: 3 countries
• Sites: 3

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.

Conditions

Infertility; Pregnancy, Multiple

Keywords

embryo; in vitro fertilization; IVF

Outcome Measures

Primary Outcomes (1)

• Clinical pregnancy (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 Outcomes (5)

• Blastocyst grade (Gardner scale)

  5-6 days

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

  2-3 weeks

• Clinical pregnancy (5-6 weeks)

  5-6 weeks

• Fertilization rate

  1 day

• Day 3 morphology

  3 days

Study Arms (1)

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

Interventions

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.

Also known as: Micropipette Aspiration, Mechanical Measurement

Measurement Group

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (3)

Stanford University IVF clinic

Stanford, California, 94305, United States

Location

Shenzhen Army and Police Hospital--Reproductive Unit

Shenzhen, China

Location

Taiwan IVF Group

Hsinchu, Taiwan

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Valerie Baker, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2015
• First Posted: August 21, 2015
• Study Start: August 1, 2015
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2018
• Last Updated: February 16, 2021

Record last verified: 2021-02

Locations

CN (1); TW (1); US (1)