Infertility Clinical Trial
— EMECHOfficial title:
Measuring the Relationship Between Ooocyte and Embryo Mechanical Properties and Embryo Development After In Vitro Fertilization
NCT number | NCT02530892 |
Other study ID # | 31948 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | August 2015 |
Est. completion date | June 30, 2018 |
Verified date | February 2021 |
Source | Stanford University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Stanford University |
United States, China, Taiwan,
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 |
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