Round Spermatid Injection Protocol

NCT04053309 | Terminated

• 1 other identifier: RMA-2019-03
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate embryology outcomes after application of a technique known as round spermatid injection (ROSI) into donor oocytes in a high-volume clinical infertility practice.

Conditions

Male Infertility Due to Azoospermia

Outcome Measures

Primary Outcomes (1)

• Euploid blastulation rate

  number of fertilized eggs progressing to the blastocyst stage of development which are euploid

  1-2 weeks

Secondary Outcomes (4)

• Fertilization Rate

  1 day post intracytoplasmic sperm injection procedure

• Prevalence of round spermatids in surgical sperm samples

  immediately after the TESE or microTESE

• Overall blastulation rate

  1 week

• Aneuploidy rate

  2 weeks

Study Arms (1)

Males undergoing TESE or microTESE

All male patients undergoing surgical sperm extraction (TESE or microTESE) procedures as part of an IVF cycle at our center will be reviewed for inclusion and offered participation in the study. These men have been previously consented to the TESE or microTESE procedure at our center. The study will utilize the otherwise discarded round spermatids found in the TESE and microTESE surgical samples as the study samples being used for the ROSI procedure.

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

At least 10 healthy oocyte donors and at least 10 male patients with a diagnosis of male factor infertility (undergoing TESE or microTESE) to participate in this study. All male patients undergoing surgical sperm extraction (TESE or microTESE) procedures as part of an IVF cycle at our center will be reviewed for inclusion and offered participation in the study. These men have been previously consented to the TESE or microTESE procedure at our center. The study will utilize the otherwise discarded round spermatids found in the TESE and microTESE surgical samples as the study samples being used for the ROSI procedure.

You may qualify if:

• A diagnosis of azoospermia after semen analysis.
• Indication to proceed with testicular sperm extraction (TESE or microTESE) based on a urologic evaluation.
• Presence of round spermatids from testicular sperm extraction (TESE or microTESE), irrespective of the presence or absence of mature spermatozoa.

You may not qualify if:

• Under 18 years old
• All patients who do not voluntarily give their written consent for participation.
• Men who do not wish to use their gametes (round spermatids) for fertilization of donor oocytes for research purposes.

Sponsors & Collaborators

• Reproductive Medicine Associates of New Jersey: lead

Study Sites (1)

Reproductive Medicine Assoicates of New Jersey

Basking Ridge, New Jersey, 07920, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

a blood sample of buccal swab will be obtained for DNA extraction

Study Officials

• Brent Hanson, MD

  Reproductive Medicine Associates of New Jersey

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2019
• First Posted: August 12, 2019
• Study Start: August 16, 2019
• Primary Completion: January 8, 2021
• Study Completion: January 8, 2021
• Last Updated: May 19, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)