Round Spermatid Injection Protocol (ROSI)

Reproductive Medicine Associates of New Jersey

Status: Terminated

Conditions: Male Infertility Due to Azoospermia

Study type: Observational

Funder types: Other

Identifiers

NCT04053309

RMA-2019-03

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

3 participants in 1 patient group

Males undergoing TESE or microTESE

Description:

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.