Clinical trial NCT04053309: Round Spermatid Injection Protocol
Official title: Implementation of a Round Spermatid Injection Protocol in a Clinical Infertility Practice
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Male Infertility Due to Azoospermia
Lead sponsor: Reproductive Medicine Associates of New Jersey
Sponsor class: OTHER
First posted: 2019-08-12
Enrollment: 3
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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.

Primary outcomes:
measure: Euploid blastulation rate
timeFrame: 1-2 weeks
Secondary outcomes:
measure: Fertilization Rate
timeFrame: 1 day post intracytoplasmic sperm injection procedure
measure: Prevalence of round spermatids in surgical sperm samples
timeFrame: immediately after the TESE or microTESE
measure: Overall blastulation rate
timeFrame: 1 week
measure: Aneuploidy rate
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Reproductive Medicine Assoicates of New Jersey
state: New Jersey
Study officials:
affiliation: Reproductive Medicine Associates of New Jersey
name: Brent Hanson, MD
role: STUDY_DIRECTOR
References: