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

JRCT ID: jRCT1060220105

Registered date:03/03/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: infertility
• Date of first enrollment: 01/03/2023
• Target sample size: 500
• Study type: Interventional

Intervention(s)

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 concentration, motility, and total motile sperm count are measured using a Makler counting chamber (Sefi-Medical Instruments, Jerusalem, Israel) after liquefaction of the semen. Then, according to the allocation result, good sperm is recovered using either the ZyMot or conventional method and used for ICSI.

Intervention Group: ZyMot Group Insemination medium 50 microl is injected into the sperm recovery port of the ZyMot Multi (850 microl) plate, followed by injecting 850 microl of semen into the sperm injection port, and finally, 700 microl of Insemination medium is poured into the recovery chamber and left standing at 37.0 degrees Celsius in an incubator. After 30 minutes of standing, 500 microl of sperm is collected from the ZyMot sperm recovery port for ICSI.

Control Group: Conventional Group (e.g., using ISolate Sperm Separation medium) Sperm processing of the submitted semen sample is performed on the day of oocyte retrieval. (1) Sperm preparation is performed using a density gradient centrifugation method. (The solution used for the density gradient is the one adopted by each institution, and the density gradient method is performed according to the instructions.) (2) Sperm washing is performed using a culture medium. (3) Swim-up method is performed in the incubator. After the Swim-up method, 300 microl is collected from the upper layer of the culture medium and used for ICSI.

Outcome(s)

Primary Outcome

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 Outcome

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.

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: < 43age old
• Gender: Female

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Toshihiro Habara