Landon Trost, Sevann Helo, Klinton Brearton, Riley Warner, Matthew Ziegelmann, Tobias Kohler, Joshua Savage
{"title":"泼尼松对输精管切除术逆转结果的影响（iPRED 研究）：随机对照临床试验结果。","authors":"Landon Trost, Sevann Helo, Klinton Brearton, Riley Warner, Matthew Ziegelmann, Tobias Kohler, Joshua Savage","doi":"10.1016/j.fertnstert.2024.11.019","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>To evaluate the safety and efficacy of prednisone on pregnancy rates and semen concentrations at 1 year after vasectomy reversal.</p><p><strong>Design: </strong>Randomized, controlled trial (NCT04788823).</p><p><strong>Setting: </strong>Single medical center specializing in vasectomy reversals.</p><p><strong>Patient(s): </strong>Men undergoing vasectomy reversal.</p><p><strong>Intervention(s): </strong>Participants were randomly assigned 1:1:1:1 to Control (no prednisone), Pred High (20 mg prednisone taper, every other month × 3 months), Pred PRN (20 mg prednisone taper × 3 courses maximum if sperm counts were declining or 0), and Pred Low (5 mg/d, every other week × 6 months). Note that Pred High and Pred PRN were stopped prematurely due to interim findings demonstrating lower pregnancy rates.</p><p><strong>Main outcome measure(s): </strong>Pregnancy rates, semen concentrations, and adverse events. The current study reports outcomes at 1 year.</p><p><strong>Result(s): </strong>A total of 75 men were enrolled, with 1-year data available in 73 (Control, n = 25; Pred High, n = 14; Pred PRN, n = 11; and Pred Low, n = 23). Baseline factors were similar among cohorts. Pregnancy rates at 12 months were higher in Controls (65%) and Pred Low (67%) compared with Pred High (17%) and Pred PRN (38%). Overall patency at 12 months (sperm at any point) was 99%, with no statistically significant differences noted between groups for patency, median concentrations by month (range, 3-42), or overall median concentrations (median of medians range, 5-16).</p><p><strong>Conclusion(s): </strong>High-dose (20 mg) prednisone results in decreased pregnancy rates after vasectomy reversal, an effect which is independent of sperm concentration, dose dependent, and persists for months after discontinuation. Prednisone doses (ranging from 5 to 20 mg) do not impact sperm concentrations.</p><p><strong>Clinical trial registration number: </strong>NCT04788823 (https://clinicaltrials.gov/study/NCT04788823?term=NCT04788823&rank=1).</p>","PeriodicalId":12275,"journal":{"name":"Fertility and sterility","volume":" ","pages":""},"PeriodicalIF":6.6000,"publicationDate":"2024-11-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Impact of prednisone on vasectomy reversal outcomes (iPRED study): results from a randomized, controlled clinical trial.\",\"authors\":\"Landon Trost, Sevann Helo, Klinton Brearton, Riley Warner, Matthew Ziegelmann, Tobias Kohler, Joshua Savage\",\"doi\":\"10.1016/j.fertnstert.2024.11.019\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objective: </strong>To evaluate the safety and efficacy of prednisone on pregnancy rates and semen concentrations at 1 year after vasectomy reversal.</p><p><strong>Design: </strong>Randomized, controlled trial (NCT04788823).</p><p><strong>Setting: </strong>Single medical center specializing in vasectomy reversals.</p><p><strong>Patient(s): </strong>Men undergoing vasectomy reversal.</p><p><strong>Intervention(s): </strong>Participants were randomly assigned 1:1:1:1 to Control (no prednisone), Pred High (20 mg prednisone taper, every other month × 3 months), Pred PRN (20 mg prednisone taper × 3 courses maximum if sperm counts were declining or 0), and Pred Low (5 mg/d, every other week × 6 months). Note that Pred High and Pred PRN were stopped prematurely due to interim findings demonstrating lower pregnancy rates.</p><p><strong>Main outcome measure(s): </strong>Pregnancy rates, semen concentrations, and adverse events. The current study reports outcomes at 1 year.</p><p><strong>Result(s): </strong>A total of 75 men were enrolled, with 1-year data available in 73 (Control, n = 25; Pred High, n = 14; Pred PRN, n = 11; and Pred Low, n = 23). Baseline factors were similar among cohorts. Pregnancy rates at 12 months were higher in Controls (65%) and Pred Low (67%) compared with Pred High (17%) and Pred PRN (38%). Overall patency at 12 months (sperm at any point) was 99%, with no statistically significant differences noted between groups for patency, median concentrations by month (range, 3-42), or overall median concentrations (median of medians range, 5-16).</p><p><strong>Conclusion(s): </strong>High-dose (20 mg) prednisone results in decreased pregnancy rates after vasectomy reversal, an effect which is independent of sperm concentration, dose dependent, and persists for months after discontinuation. Prednisone doses (ranging from 5 to 20 mg) do not impact sperm concentrations.</p><p><strong>Clinical trial registration number: </strong>NCT04788823 (https://clinicaltrials.gov/study/NCT04788823?term=NCT04788823&rank=1).</p>\",\"PeriodicalId\":12275,\"journal\":{\"name\":\"Fertility and sterility\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":6.6000,\"publicationDate\":\"2024-11-20\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Fertility and sterility\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1016/j.fertnstert.2024.11.019\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"OBSTETRICS & GYNECOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Fertility and sterility","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.fertnstert.2024.11.019","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"OBSTETRICS & GYNECOLOGY","Score":null,"Total":0}
引用次数: 0
摘要
目的评估泼尼松对输精管结扎逆转术（VR）术后1年的妊娠率和精液浓度的安全性和有效性：随机对照试验（NCT04788823）：患者：接受输精管结扎逆转术的男性：患者：接受输精管结扎逆转术的男性：参与者按1:1:1:1随机分配到对照组（不使用泼尼松）、Pred High（20 毫克泼尼松减量，每隔一个月 x 3 个月）、Pred PRN（20 毫克泼尼松减量 x 3 个疗程，如果精子数量下降或为 0，则最多使用 3 个疗程）和 Pred Low（5 毫克/天，每隔一周 x 6 个月）。请注意，Pred High 和 Pred PRN 因中期研究结果显示怀孕率较低而提前停止：主要结果指标：妊娠率、精液浓度和不良事件。目前的研究报告了 1 年的结果：75名男性参加了研究，其中73人获得了1年的数据（对照组，25人；Pred High组，14人；Pred PRN组，11人；Pred Low组，23人）。各组的基线因素相似。对照组（65%）和 Pred Low 组（67%）12 个月的妊娠率高于 Pred High 组（17%）和 Pred PRN 组（38%），P=0.02。12 个月时的总体通畅率（任何时间点的精子）为 99%，各组之间在通畅率、各月浓度中位数（范围 3-42）或总体浓度中位数（中位数范围 5-16）方面无显著统计学差异：结论：大剂量（20 毫克）泼尼松会降低静脉输液后的妊娠率，这种影响与精子浓度无关，与剂量有关，并在停药后持续数月。泼尼松在 5-20 毫克的剂量范围内不会影响精子浓度。
Setting: Single medical center specializing in vasectomy reversals.
Patient(s): Men undergoing vasectomy reversal.
Intervention(s): Participants were randomly assigned 1:1:1:1 to Control (no prednisone), Pred High (20 mg prednisone taper, every other month × 3 months), Pred PRN (20 mg prednisone taper × 3 courses maximum if sperm counts were declining or 0), and Pred Low (5 mg/d, every other week × 6 months). Note that Pred High and Pred PRN were stopped prematurely due to interim findings demonstrating lower pregnancy rates.
Main outcome measure(s): Pregnancy rates, semen concentrations, and adverse events. The current study reports outcomes at 1 year.
Result(s): A total of 75 men were enrolled, with 1-year data available in 73 (Control, n = 25; Pred High, n = 14; Pred PRN, n = 11; and Pred Low, n = 23). Baseline factors were similar among cohorts. Pregnancy rates at 12 months were higher in Controls (65%) and Pred Low (67%) compared with Pred High (17%) and Pred PRN (38%). Overall patency at 12 months (sperm at any point) was 99%, with no statistically significant differences noted between groups for patency, median concentrations by month (range, 3-42), or overall median concentrations (median of medians range, 5-16).
Conclusion(s): High-dose (20 mg) prednisone results in decreased pregnancy rates after vasectomy reversal, an effect which is independent of sperm concentration, dose dependent, and persists for months after discontinuation. Prednisone doses (ranging from 5 to 20 mg) do not impact sperm concentrations.
期刊介绍：
Fertility and Sterility® is an international journal for obstetricians, gynecologists, reproductive endocrinologists, urologists, basic scientists and others who treat and investigate problems of infertility and human reproductive disorders. The journal publishes juried original scientific articles in clinical and laboratory research relevant to reproductive endocrinology, urology, andrology, physiology, immunology, genetics, contraception, and menopause. Fertility and Sterility® encourages and supports meaningful basic and clinical research, and facilitates and promotes excellence in professional education, in the field of reproductive medicine.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
