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The evaluation of the efficacy of a microfluidics device for sperm sorting

A multi-institutional prospective randomized controlled trial of ICSI outcomes using ZyMOT (ZyMOT), a sperm sorting device using microfluidic technology, and conventional sperm preparation methods (density gradient method, swim-up method)

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1060220105
Enrollment
500
Registered
2023-03-03
Start date
2023-03-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

infertility

Interventions

Sperm Processing Method: On the day of oocyte retrieval, the sperm collected into a sterile cup by manual methods is used. After submission, the volume of the semen is measured, and sperm concentratio

Sponsors

Toshihiro Habara
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Blastocyst development rate in ICSI using sperm obtained by sperm preparation using ZyMOT and the one using conventional methods. 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 (%). (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) *We will evaluate the improvement in embryo quality of fertilized oocytes using sperm obtained by ZyMOT .

Secondary

MeasureTime frame
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. 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. 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. The number of miscarriages is determined after a clinical pregnancy.

Contacts

Public ContactAoi Yoko

Okayama couple`s clinic

labo@futari.or.jp+81-862567717

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026