ROSI: Round Spermatid Injection Protocol
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Outcome Measures
Primary Outcome Measures
- Euploid blastulation rate [1-2 weeks]
number of fertilized eggs progressing to the blastocyst stage of development which are euploid
Secondary Outcome Measures
- 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
Eligibility Criteria
Criteria
Major Inclusion Criteria: The following are major inclusion criteria:
-
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.
Major Exclusion Criteria (must not meet any): The following are exclusion criteria:
-
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Reproductive Medicine Assoicates of New Jersey | Basking Ridge | New Jersey | United States | 07920 |
Sponsors and Collaborators
- Reproductive Medicine Associates of New Jersey
Investigators
- Study Director: Brent Hanson, MD, Reproductive Medicine Associates of New Jersey
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RMA-2019-03