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临床试验/CTRI/2020/11/029076
CTRI/2020/11/029076尚未招募不适用

Testis Expressed Sequence 101, Prostate Specific Antigen Antibodies and Malondialdehyde Acid in Qualitative Assessment of Seminal Plasma in Male Infertility: A Comparative Study

AIIMS Mangalagiri1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2020年1月12日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
160
试验地点
1
主要终点
To evaluate the role of seminal plasma TEX 101, PSA antibodies and MDA levels as biomarkers of male infertility.

研究概览

简要总结

Infertility is a major problem now-a-day and both maleand female factor infertility are rising. Males are solely responsible for around 20-30% ofinfertility cases but contribute to 50% of cases overall. According to WHO theestimated prevalence of primary infertility in India ranges between 3.9 and16.8% with a prevalence of 5% in Andhra Pradesh. Male infertility is multifactorial in origin withenvironmental, genetic, life-style changes, oxidative stress, all contributingin its development. Semen analysis is considered as gold standard test fordiagnosis of male infertility, but it is crude method as seminal fluidcomposition gets affected by environmental factors, infections and otherpathologies, leading to unreliable reports and delay in diagnosis andtreatment.10 Hence, newer tests are being assessed including seminalbiomarkers for better estimation of male infertility and its underlying cause.Human seminal fluid contains highest concentration of molecules derived from malereproductive glands, which can be studied to know cause of male infertility.Some of these seminal plasma biomarkers include Testicular expressedsequence 101 (TEX 101) located on plasma membrane of germ cells during allstages of spermatogenesis. It is essential for sperm maturation, zona bindingand can differentiate between obstructive and non-obstructive azoospermia.Another important biomarker for immuno-infertility is Prostatic specificantigen antibodies. Presence of these antibodies have been identified as animportant cause of male infertility. Furthermore, mammalian spermatozoa are rich inpolyunsaturated fatty acids, which are vulnerable to reactive oxygen speciesattack. One end-product of this sperm lipid peroxidation is malondialdehydeacid (MDA). High levels of seminal MDA cause oxidative damage to the spermmembranes.

Hence, study will be conducted to assess role ofseminal plasma TEX 101, PSA antibodies and MDA levels in patients with maleinfertility, so that newer non-invasive methods can be developed for bettermanagement of male infertility.

研究设计

研究类型
Observational

入排标准

年龄范围
20.00 Year(s) 至 50.00 Year(s)(—)
性别
Male

入选标准

  • Cases: All couples with male factor infertility as diagnosed on semen analysis will be included as cases Controls: All male partners of infertile couples with normal semen analysis will be enrolled as controls.
  • The male partners in both cases and controls will be selected from 20-50 years of age group.

排除标准

  • Male partners with acute infection, fever, subjects currently on some infertility treatment or drugs, subjects with chronic diseases like diabetes mellitus, renal or liver diseases, prostate or any other malignancy, subjects with aspermia, cryptorchidism, bilateral absence of vasa deferens (CABVD), testicular dysgenesis syndrome or any other congenital abnormalities, subjects with Hypospadias or Retrograde ejaculation will be excluded from cases and controls.

结局指标

主要结局

To evaluate the role of seminal plasma TEX 101, PSA antibodies and MDA levels as biomarkers of male infertility.

时间窗: The values of seminal plasma TEX 101, PSA antibodies and MDA levels as biomarkers of male infertility will be assessed after 1 year.

次要结局

  • To develop effective non - invasive seminal plasma biomarkers for detection of causes of male infertility.

研究者

申办方类型
Research institution and hospital

研究点 (1)

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