Round Spermatid Injection Protocol (ROSI)

Implementation of a Round Spermatid Injection Protocol in a Clinical Infertility Practice

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.

Study Overview

• Status: Terminated
• Conditions: Male Infertility Due to Azoospermia

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 Type: Observational
• Enrollment (Actual): 3

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Basking Ridge, New Jersey, United States, 07920
      • Reproductive Medicine Assoicates of New Jersey

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Male

• 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.

Description

Major 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Euploid blastulation rate	number of fertilized eggs progressing to the blastocyst stage of development which are euploid	1-2 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Reproductive Medicine Associates of New Jersey

Study record dates

Study Major Dates

• Study Start (Actual): August 16, 2019
• Primary Completion (Actual): January 8, 2021
• Study Completion (Actual): January 8, 2021

Study Registration Dates

• First Submitted: August 9, 2019
• First Submitted That Met QC Criteria: August 9, 2019
• First Posted (Actual): August 12, 2019

Study Record Updates

• Last Update Posted (Actual): May 19, 2021
• Last Update Submitted That Met QC Criteria: May 18, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility; Infertility, Male; Azoospermia
• Other Study ID Numbers: RMA-2019-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No