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临床试验/NCT04298255
NCT04298255招募中不适用

Experimental Round Spermatid Injection (ROSI) to Treat Infertile Couples

Wake Forest University Health Sciences2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年8月24日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
2
主要终点
Fertility rate

研究概览

简要总结

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.

详细描述

Azoospermia is defined as the absence of sperm in the ejaculate. Around 1% of general population suffers from azoospermia. Men who were rendered infertile due to a non-obstructive azoospermia, who have been subjected to Testicular Sperm Extraction (TESE) surgery and found to be lacking elongated spermatids or spermatozoa, are commonly advised to consider utilizing a sperm donor or apply for adoption. It is reported that ~30% of men with non-obstructive azoospermia lack elongated spermatids and spermatozoa but may still produce round spermatids (less mature form of haploid germ cells) in their testicles. Round Spermatid Injection (ROSI) technology to fertilize oocytes is not a brand-new technology, however, it is plagued with notoriously low efficiency. Despite this limitation, it has been reported that most of these patients still desire to have the ROSI procedure instead of applying directly for other options, i.e. sperm donation or adoption.

High failure rate of traditional ROSI has been attributed to a few potential causes:

  1. Incorrect selection of round spermatids (to distinguish from diploid spermatogonia cells)
  2. Using round spermatids that were already in the process of degeneration
  3. Incomplete imprinting in the round spermatid
  4. Incomplete activation of oocytes Recently Tanaka and colleagues in Japan established a new ROSI method and reported over 90 babies born via this method1. They described a new method of round spermatid selection and oocyte activation using NEPA21 super electroporator (10 minutes prior to round spermatid injection).

Babies born from this new ROSI method in Japan have been evaluated for developmental and cognitive differences for 2 years1. Babies conceived with ROSI were found to have a shorter gestation times, and lower body weight at 12 and 18 months when compared to their naturally conceived counterparts, but also showed an increased birth weight and showed no body weight differences at 24 months of age. No diseases resulting from genetic anomalies have been reported thus far, but the relatively small sample sizes present in the literature needs to be tested in larger cohorts. Therefore, this effective ROSI method should still be considered as an "experimental fertility treatment".

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • 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.

排除标准

  • Males with obstructive azoospermia
  • Males with presence an adequate number of elongated spermatids or spermatozoa

研究组 & 干预措施

ROSI only

Experimental

Option 1: injecting extracted round spermatids (less mature form of haploid germ cells than elongated spermatid or spermatozoon) from male partner into the harvested egg of a female partner

干预措施: Round Spermatid Injection (ROSI) (Other)

Half ROSI-half Sperm Donor Fertilization

Experimental

Option 2: Harvested eggs from the female partner will be separated in two groups, with one group being fertilized with round spermatids and the other group fertilized with donor sperm

干预措施: Half ROSI-half Sperm Donor Fertilization (Other)

结局指标

主要结局

Fertility rate

时间窗: Day 1 after round spermatid injection

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.

次要结局

  • Aneuploidy rate(Day 3 to 5 after round spermatid injection)
  • Chemical Pregnancy with Positive human chorionic gonadotropin (hCG)(Post Fertilization 4 Weeks and onwards)
  • Live Birth Rate(Post Pregnancy Full Term Average 39 to 40 weeks)
  • Blastocyst formation(Day 3 to 5 after round spermatid injection)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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