The evaluation of the efficacy of a microfluidics device for sperm sorting
Phase 3
Recruiting
- Conditions
- infertility
- Registration Number
- JPRN-jRCT1060220105
- Lead Sponsor
- Toshihiro Habara
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 500
Inclusion Criteria
Couples for whom no transferable embryos were obtained after one or more ICSI procedures, or for whom embryo transfer did not result in pregnancy.
Couples who plan to undergo ICSI at the next oocyte retrieval.
Couples who are able to give written consent of their own free will.
Exclusion Criteria
Couples who meet any of the following criteria.
Couples in which the male has severe oligozoospermia.
Couples in which the male is eligible for TESE TESA PESA.
Couples who plan to use frozen-thawed sperm.
Couples in which the age of the woman at a time when producing an assisted reproductive treatment plan is 43 years or older.
Any other couple that the principal investigator deems inappropriate for the safe conduct of this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Blastocyst development rate in ICSI using sperm obtained by sperm preparation using ZyMOT and the one using conventional methods.<br>Blastocyst development rate: On day 5-6 of culture, the blastocyst morphology is evaluated based on the Gardner classification, and the percentage of blastocysts that develop into blastocysts is determined. The blastocyst development rate is calculated as: the number of blastocysts / the number of additional embryos cultured after the third day of egg retrieval x 100 (%).<br>(Number of additional embryos cultured on day 3 after oocyte retrieval =2PN number - the number of embryos transferred on day 2 or 3 after oocyte retrieval)<br>*We will evaluate the improvement in embryo quality of fertilized oocytes using sperm obtained by ZyMOT .
- Secondary Outcome Measures
Name Time Method Good Blastocyst development rate: On day 5-6 of culture, the blastocyst morphology is evaluated on the Gardner classification to determine the percentage of blastocysts that develop to a grade of 3BB or higher. <br>The clinical pregnancy rate is determined when the blood hCG concentration is 50 mIU/ml or more round the 14th day after embryo transfer and the gestational sac is confirmed at 6 to 8 weeks after transfer. <br>Implantation is determined when the blood hCG concentration is 50 mIU/ml or more around the 14th day after embryo transfer and when the gestational sac is confirmed by vaginal ultrasonography at 6 to 8 weeks after transfer, and then the implantation rate is calculated. <br>The number of miscarriages is determined after a clinical pregnancy.