Round Spermatid Injection Protocol

Terminated

• Conditions: Male Infertility Due to Azoospermia

• Registration Number: NCT04053309
• Lead Sponsor: Reproductive Medicine Associates of New Jersey

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.

Detailed Description

The objective of this study is to assess embryology outcomes after implementation of a laboratory protocol known as ROSI at a high-volume clinical infertility practice. All samples from enrolled male patients with azoospermia who proceed with surgical sperm extraction (TESE or microTESE) will be evaluated for the presence of round spermatids. These round spermatids will be used as research samples as opposed to being discarded.

The investigators aim to identify whether the injection of round spermatids into donor oocytes can lead to successful fertilization, progression to the blastocyst stage, and euploid status. Performance of ROSI using donor oocytes not intended for implantation will allow the investigators to gain valuable insight regarding fertilization and development without any direct risk to patients or future offspring. These embryos are being generated for research purposes only and will ultimately be destroyed after the study has concluded. The investigators will measure rates of isolation of round spermatids from surgical samples, fertilization rates using donor oocytes, rates of progression to the blastocyst stage, and rates of aneuploidy using the previously described technique of ROSI.

Study Timeline

• Study First Submitted: 2019-08-09
• Study First Submitted QC: 2019-08-09
• Study First Posted: 2019-08-12
• Study Start: 2019-08-16
• Primary Completion: 2021-01-08
• Study Completion: 2021-01-08
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-18
• Last Update Posted: 2021-05-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 3

Inclusion Criteria

The following are major inclusion criteria:

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

Major Exclusion Criteria (must not meet any): The following are exclusion criteria:

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Euploid blastulation rate	1-2 weeks	number of fertilized eggs progressing to the blastocyst stage of development which are euploid

Secondary Outcome Measures

Name	Time	Method
Fertilization Rate	1 day post intracytoplasmic sperm injection procedure	Number of mature eggs fertilized by round spermatids
Prevalence of round spermatids in surgical sperm samples	immediately after the TESE or microTESE	the number of round spermatids present after a TESE or microTESE procedure is performed
Overall blastulation rate	1 week	number of fertilized eggs progressing to the blastocyst stage of development
Aneuploidy rate	2 weeks	the number of abnormal embryos after PGT-A

Trial Locations

Locations (1)

Reproductive Medicine Assoicates of New Jersey; 🇺🇸 Basking Ridge, New Jersey, United States