Study Summary
This trial is testing if it's possible to use a cell called a round spermatid to create a pregnancy, without using sperm. They will also test the safety of this method and what effects it has on the embryo.
- Male Infertility
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 4 Secondary · Reporting Duration: Post Pregnancy Full Term Average 39 to 40 weeks
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Half ROSI-half Sperm Donor Fertilization
1 of 2
ROSI only
1 of 2
Experimental Treatment
50 Total Participants · 2 Treatment Groups
Primary Treatment: Round Spermatid Injection (ROSI) · No Placebo Group · N/A
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18+ · Male Participants · 4 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:- Tanaka, Atsushi, Motoi Nagayoshi, Youichi Takemoto, Izumi Tanaka, Hiroshi Kusunoki, Seiji Watanabe, Keiji Kuroda, Satoru Takeda, Masahiko Ito, and Ryuzo Yanagimachi. 2015. “Fourteen Babies Born After Round Spermatid Injection into Human Oocytes”. Proceedings of the National Academy of Sciences. Proceedings of the National Academy of Sciences. doi:10.1073/pnas.1517466112.
- Tanaka, Atsushi, Kohta Suzuki, Motoi Nagayoshi, Akihiro Tanaka, Youichi Takemoto, Seiji Watanabe, Satoru Takeda, et al.. 2018. “Ninety Babies Born After Round Spermatid Injection into Oocytes: Survey of Their Development from Fertilization to 2 Years of Age”. Fertility and Sterility. Elsevier BV. doi:10.1016/j.fertnstert.2018.04.033.
- Bradshaw, Aaron William, Banafsheh Nikmehr, Cihan Halicigil, Kimberly Stogner‐Underwood, and Hooman Sadri‐Ardekani. 2021. “Optimum Identification of Round Spermatid in Men with Non‐obstructive Azoospermia: A Commentary”. Andrology. Wiley. doi:10.1111/andr.13113.
- Bradshaw AW, Nikmehr B, Halicigil C, Stogner-Underwood K, Sadri-Ardekani H. Optimum identification of round spermatid in men with non-obstructive azoospermia: A commentary. Andrology. 2021 Nov;9(6):1817-1818. doi: 10.1111/andr.13113. Epub 2021 Oct 14. No abstract available.
- Tanaka A, Nagayoshi M, Takemoto Y, Tanaka I, Kusunoki H, Watanabe S, Kuroda K, Takeda S, Ito M, Yanagimachi R. Fourteen babies born after round spermatid injection into human oocytes. Proc Natl Acad Sci U S A. 2015 Nov 24;112(47):14629-34. doi: 10.1073/pnas.1517466112. Epub 2015 Nov 2. Erratum In: Proc Natl Acad Sci U S A. 2016 May 17;113(20):E2872.
- 2020. "Experimental Round Spermatid Injection (ROSI) to Treat Infertile Couples". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04298255.
Frequently Asked Questions
How many participants are contributing to this research trial?
"Affirmative, the information hosted on clinicaltrials.gov reveals that this trial is presently searching for participants. It was initially uploaded to the platform on August 24th 2020 and most recently updated on October 22nd 2022. The study requires 50 patients from one center of care." - Anonymous Online Contributor
Are patients being recruited for this trial at the present time?
"Indeed, according to clinicaltrials.gov the trial is still looking for participants; it was posted on August 24th 2020 and last modified October 26th 2022. The research necessitates 50 volunteers from a single medical centre." - Anonymous Online Contributor