Clinical trial NCT02530892: Correlation Between Oocyte and Embryo Mechanical Properties on Embryo Development and Clinical Pregnancy After In Vitro Fertilization
Official title: Measuring the Relationship Between Ooocyte and Embryo Mechanical Properties and Embryo Development After In Vitro Fertilization
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility
Pregnancy, Multiple
Keywords: embryo
in vitro fertilization
IVF
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2015-08-21
Enrollment: 119
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Clinical pregnancy (8-10 weeks)
timeFrame: 8-10 weeks
Secondary outcomes:
measure: Blastocyst grade (Gardner scale)
timeFrame: 5-6 days
measure: Pregnancy test result (based on human chorionic gonadotropin (hCG) levels)
timeFrame: 2-3 weeks
measure: Clinical pregnancy (5-6 weeks)
timeFrame: 5-6 weeks
measure: Fertilization rate
timeFrame: 1 day
measure: Day 3 morphology
timeFrame: 3 days
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University IVF clinic
state: California
city: Shenzhen
country: China
facility: Shenzhen Army and Police Hospital--Reproductive Unit
city: Hsinchu
country: Taiwan
facility: Taiwan IVF Group
Study officials:
affiliation: Stanford University
name: Valerie Baker, MD
role: PRINCIPAL_INVESTIGATOR
References: