Experimental Round Spermatid Injection (ROSI) to Treat Infertile Couples
ConditionInfertility, Male
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorWake Forest University Health Sciences
About this trial
The purpose of this research study is to evaluate if special types of cells called round spermatids can be gathered from men with non-obstructive azoospermia and used (in absence of elongated spermatids and spermatozoa) to reliably and effectively create pregnancy with a procedure called Round Spermatid Injection (ROSI). This process is similar to In Vitro Fertilization, or 'IVF'. In addition, this study wants to test the safety of ROSI and see what effects (good and bad) it has on embryo created from this method.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Males with no elongated spermatids or spermatozoa present but with round spermatids present on TESE (Testicular Sperm Extraction)
Male diagnosed with non-obstructive Azoospermia
Male partner ≥18
Female partner greater than 18 years of age and less than 38 years of age or Anti Mullerian Hormone (AMH) greater than 2 ng/ml.
Disqualifiers
Males with obstructive azoospermia
Males with presence an adequate number of elongated spermatids or spermatozoa
Trial design
Design model
Single group
Treatments tested in this trial
Round Spermatid Injection (ROSI)
Other interventionIn Vitro Fertilization using Round Spermatid Injection (ROSI)
Half ROSI-half Sperm Donor Fertilization
Other interventionHalf ROSI-half Sperm Donor Fertilization
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: ROSI onlyExperimental treatment 1 intervention
Group B: Half ROSI-half Sperm Donor FertilizationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Fertility rate
Egg fertilization comparison between the groups undergoing the procedure with spermatids only vs spermatids and donor sperms.This fertilization process will be recorded by EmbryoScope under supervision of dedicated clinical embryologist.All the process will be followed and documented according to America Society of Reproductive Medicine (ASRM) guidelines. All the process will be followed and documented according to American Society for Reproductive Medicine (ASRM) guidelines.
Time frame
Day 1 after round spermatid injectionSecondary outcomes
1
Blastocyst formation
Blastocyst comparison between the groups undergoing the procedure with spermatids only vs spermatids and donor sperms.Embryo grow and blastocyst formation will be recorded by EmbryoScope under supervision of dedicated clinical embryologist.All the process will be followed and documented according to American Society for Reproductive Medicine (ASRM) guidelines.
Time frame
Day 3 to 5 after round spermatid injection2
Aneuploidy rate
Aneuploidy comparison and evaluation of abnormality between the groups undergoing the procedure with spermatids only vs spermatids and donor sperms. Aneuploidy will be tested using polymerase chain reaction amplification (PCR) based Preimplantation genetic diagnosis (PGD) and fluorescent in situ hybridization (FISH) analyses. All the process will be followed and documented according to American Society for Reproductive Medicine (ASRM) guidelines.
Time frame
Day 3 to 5 after round spermatid injection3
Chemical Pregnancy with Positive human chorionic gonadotropin (hCG)
Pregnancy Rate between the groups undergoing the procedure with spermatids only vs spermatids and donor sperms. Blood test to measure beta-hCG (chemical pregnancy) and follows by Ultrasound (clinical pregnancy). All the process will be followed and documented according to American Society for Reproductive Medicine (ASRM) guidelines.
Time frame
Post Fertilization 4 Weeks and onwards4
Live Birth Rate
Live Birth comparison between the groups undergoing the procedure with spermatids only vs spermatids and donor sperms. Pregnancy will be followed as high risk and health of born children will be evaluated by a dedicated neonatologist/Pediatrician. All the process will be followed and documented according to American Society for Reproductive Medicine (ASRM) guidelines.
Time frame
Post Pregnancy Full Term Average 39 to 40 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Wake Forest University Health Sciences
Lead sponsor
Carolinas Fertility Institute (CFI)
Collaborator
Wake Forest Institute for Regenerative Medicine (WFIRM)
Collaborator
Wake Forest Department of Urology
Collaborator
Source ClinicalTrials.gov