Round Spermatid Injection Protocol

Male Infertility Due to Azoospermia Clinical Trial

— ROSI  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04053309
• Other study ID #: RMA-2019-03
• Status: Terminated
• Start date: August 16, 2019
• Est. completion date: January 8, 2021

Study information

• Verified date: May 2021
• Source: Reproductive Medicine Associates of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: January 8, 2021
• Est. primary completion date: January 8, 2021
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Azoospermia
• Infertility
• Infertility, Male
• Male Infertility Due to Azoospermia

Locations

Country	Name	City	State
United States	Reproductive Medicine Assoicates of New Jersey	Basking Ridge	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Reproductive Medicine Associates of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Euploid blastulation rate	number of fertilized eggs progressing to the blastocyst stage of development which are euploid	1-2 weeks
Secondary	Fertilization Rate	Number of mature eggs fertilized by round spermatids	1 day post intracytoplasmic sperm injection procedure
Secondary	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
Secondary	Overall blastulation rate	number of fertilized eggs progressing to the blastocyst stage of development	1 week
Secondary	Aneuploidy rate	the number of abnormal embryos after PGT-A	2 weeks