An observational study in Male Infertility Due to Azoospermia, sponsored by Reproductive Medicine Associates of New Jersey. Terminated at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-05-19.
Sponsored by Reproductive Medicine Associates of New Jersey · Observational
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.
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.
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.
Major Inclusion Criteria: The following are major inclusion criteria:
Major Exclusion Criteria (must not meet any): The following are exclusion criteria:
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.
Euploid blastulation rate
number of fertilized eggs progressing to the blastocyst stage of development which are euploid
Time frame: 1-2 weeks
Fertilization Rate
Number of mature eggs fertilized by round spermatids
Time frame: 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
Time frame: immediately after the TESE or microTESE
Overall blastulation rate
number of fertilized eggs progressing to the blastocyst stage of development
Time frame: 1 week
Aneuploidy rate
the number of abnormal embryos after PGT-A
Time frame: 2 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is terminated, as verified in May 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Reproductive Medicine Associates of New Jersey