Newer semen related diagnostic test for male infertility
- Conditions
- Azoospermia, (2) ICD-10 Condition: N469||Male infertility, unspecified, (3) ICD-10 Condition: N461||Oligospermia, (4) ICD-10 Condition: N468||Other male infertility,
- Registration Number
- CTRI/2020/11/029076
- Lead Sponsor
- AIIMS Mangalagiri
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- Male
- Target Recruitment
- 160
- 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.
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.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the role of seminal plasma TEX 101, PSA antibodies and MDA levels as biomarkers of male infertility. The values of seminal plasma TEX 101, PSA antibodies and MDA levels as biomarkers of male infertility will be assessed after 1 year.
- Secondary Outcome Measures
Name Time Method To develop effective non - invasive seminal plasma biomarkers for detection of causes of male infertility.
Trial Locations
- Locations (1)
All India Institute of Medical Sciences, Mangalagiri
🇮🇳Guntur, ANDHRA PRADESH, India
All India Institute of Medical Sciences, Mangalagiri🇮🇳Guntur, ANDHRA PRADESH, IndiaNaina KumarPrincipal investigator9552515600drnainakumar@gmail.com