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

Infertility Clinical Trial

— EMECH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02530892
• Other study ID #: 31948
• Status: Completed
• Start date: August 2015
• Est. completion date: June 30, 2018

Study information

• Verified date: February 2021
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: June 30, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• Pregnancy, Multiple

Intervention

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.

Locations

Country	Name	City	State
China	Shenzhen Army and Police Hospital--Reproductive Unit	Shenzhen
Taiwan	Taiwan IVF Group	Hsinchu
United States	Stanford University IVF clinic	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Countries where clinical trial is conducted

United States,  China,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Blastocyst grade (Gardner scale)	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
Secondary	Pregnancy test result (based on human chorionic gonadotropin (hCG) levels)	Outcome will be recorded as either positive or negative.	2-3 weeks
Secondary	Clinical pregnancy (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
Secondary	Fertilization rate	For oocytes measured, the fertilization of oocytes will be recorded.	1 day
Secondary	Day 3 morphology	For oocytes measured, the day 3 morphology of embryos will be recorded.	3 days