Division of Endocrinology, Department of Medicine, THarbor-UCLA Medical Center, Medical Center, West Carson, California.
Division of Endocrinology, Department of Medicine, THarbor-UCLA Medical Center, Medical Center, West Carson, California; Clinical and Translational Science Institute, The Lundquist Institute at Harbor-University of California, Los Angeles, Medical Center, West Carson, California.
Fertil Steril. 2023 Feb;119(2):208-217. doi: 10.1016/j.fertnstert.2022.11.002. Epub 2022 Nov 5.
To determine whether a user-controlled sperm concentration test compared with standard semen analysis can effectively monitor spermatogenesis suppression for male contraception.
Single center, prospective sub study of the ongoing clinical trial: "Study of daily application of Nestorone and testosterone combination gel for male contraception."
Research institute at an academic medical center.
PARTICIPANT(S): Couples participating in the male contraceptive clinical trial.
None.
MAIN OUTCOME MEASURE(S): The ability by participants to monitor sperm suppression to a threshold compatible with contraceptive efficacy utilizing a user-controlled test verified by sperm concentration determined by standard laboratory methods.
RESULT(S): Thirty-eight men participating in a hormonal male contraceptive clinical trial provided multiple samples during spermatogenesis suppression for this substudy. Participants, employing a user-controlled test, correctly identified the absence of sperm (a negative test) in 100% of their laboratory-confirmed azoospermic samples (n = 122). Participants also identified 100% of samples (n = 73) with sperm >0.2 million/mL as positive. Sperm counts between 0.01 and 0.2 million/mL were identified as negative in 96% of samples. Trial participants noted the overall ease of using the test with respect to sample preparation, test timing, and result interpretation, and that they could accurately use this test at home without difficulty.
CONCLUSION(S): Participants undergoing spermatogenesis suppression in a hormonal male contraceptive trial performed user-controlled test to determine whether their semen sperm concentration was ≤ or >0.2 million/mL. Compared with standard semen analyses, participants correctly identified 100% of samples with sperm counts >0.2 million/mL as positive (Sensitivity 100%). A positive result when the couple is using a male contraceptive method triggers the need for semen analysis by a laboratory while the couple uses another method of contraception. Participants correctly diagnosed samples ≤0.2 million sperm/mL as negative in 99% of samples (specificity 99%). A negative result indicates a sperm concentration ≤0.2 million/mL, well below the threshold of ≤1 million/mL offering contraceptive efficacy demonstrated by prior studies. At-home sperm concentration test would minimize the need for users to return to the clinic to monitor suppression of spermatogenesis, decreasing cost and burden of male contraception trials and increasing practicality of the method.
NCT: 03452111.
确定用户控制的精子浓度测试是否可以有效地监测男性避孕的生精抑制。
正在进行的临床试验的单中心前瞻性子研究：“Nestorone 和睾酮联合凝胶每日应用研究用于男性避孕”。
学术医学中心的研究所。
参与男性避孕临床试验的夫妇。
无。
参与者利用经实验室方法确定的精子浓度验证的用户控制测试来监测精子抑制到与避孕效果兼容的阈值的能力。
38 名参与激素男性避孕临床试验的男性在这项子研究中提供了多次生精抑制样本。参与者使用用户控制的测试，在其 122 个经实验室确认的无精子样本（无精子）中 100%正确识别（阴性测试）。参与者还识别出 100%的精子>0.2 百万/mL 的样本为阳性。96%的样本中，精子计数在 0.01 到 0.2 百万/mL 之间被识别为阴性。试验参与者注意到使用该测试进行样本准备、测试时间和结果解释的总体简便性，并且他们可以毫不困难地在家中准确使用该测试。
在激素男性避孕试验中进行生精抑制的参与者进行了用户控制的测试，以确定他们的精液精子浓度是否≤或>0.2 百万/mL。与标准精液分析相比，参与者正确识别出 100%的精子计数>0.2 百万/mL 的样本为阳性（灵敏度 100%）。当夫妇使用男性避孕方法时，阳性结果会触发需要实验室进行精液分析，而夫妇使用另一种避孕方法。参与者在 99%的样本中正确诊断出≤0.2 百万精子/mL 的样本为阴性（特异性 99%）。阴性结果表示精子浓度≤0.2 百万/mL，远低于先前研究证明的避孕效果的阈值≤1 百万/mL。家庭精子浓度测试将最大限度地减少用户返回诊所监测生精抑制的需求，降低男性避孕试验的成本和负担，并提高该方法的实用性。
NCT：03452111。
