Identifying Molecular Determinants of Infertility in Men (MODIFY)

NCT06147700 | Completed

• 1 other identifier: 2023-085
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to understand the underlying mechanisms of infertility caused by unknown factors. The investigator propose to identify small non-coding RNA (sncRNA) biomarkers of infertility and advance towards developing a more accurate and robust approach for infertility diagnosis.

Conditions

Male Infertility

Outcome Measures

Primary Outcomes (4)

• Semen/Sperm quantity analysis

  sperm count and concentration

  1 week

• Semen/Sperm quality analysis

  semen pH, semen volume, sperm motility, sperm morphology, sperm vitality

  1 week

• Fertility classification

  Classification into fertile/infertile groups based on the fertility measures.

  1 week

• Sperm RNA extraction and sequencing

  Sperm RNA extraction and sequencing

  3 months

Secondary Outcomes (2)

• Expression profiling of sncRNA

  3-6 months

• Comparison of the expression profiles

  3-6 months

Study Arms (2)

Healthy fertile male

No intervention for this study.

Healthy infertile male

No intervention for this study.

Eligibility Criteria

• Age: 21 Years - 50 Years
• Gender Eligibility Details: Healthy males
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy male in the general population

You may qualify if:

• Male, aged 21 - 50 years old
• Proficient in English language
• Willing to comply to study protocol
• Able to provide written informed consent

You may not qualify if:

• Current and/or previous diagnosis of Tuberculosis, Acquired immunodeficiency syndrome (AIDs), and other sexually transmitted diseases
• Experiencing severely limited mobility (eg. Wheelchair bound, need walking aid)
• Diagnosed with severe unstable mental conditions (eg. Dementia, or cognitive impairment)
• Alcohol or drug abuse

Sponsors & Collaborators

• Institute for Human Development and Potential (IHDP), Singapore: lead

Study Sites (1)

Human Development Research Centre (HDRC)

Singapore, 117597, Singapore

Location

Related Publications (10)

• Soubry A. POHaD: why we should study future fathers. Environ Epigenet. 2018 Apr 26;4(2):dvy007. doi: 10.1093/eep/dvy007. eCollection 2018 Apr.

  PMID: 29732171 BACKGROUND

• Donkin I, Barres R. Sperm epigenetics and influence of environmental factors. Mol Metab. 2018 Aug;14:1-11. doi: 10.1016/j.molmet.2018.02.006. Epub 2018 Feb 27.

  PMID: 29525406 BACKGROUND

• Khatun A, Rahman MS, Pang MG. Clinical assessment of the male fertility. Obstet Gynecol Sci. 2018 Mar;61(2):179-191. doi: 10.5468/ogs.2018.61.2.179. Epub 2018 Mar 5.

  PMID: 29564308 BACKGROUND

• Cao XW, Lin K, Li CY, Yuan CW. [A review of WHO Laboratory Manual for the Examination and Processing of Human Semen (5th edition)]. Zhonghua Nan Ke Xue. 2011 Dec;17(12):1059-63. Chinese.

  PMID: 22235670 BACKGROUND

• Zhang Y, Shi J, Rassoulzadegan M, Tuorto F, Chen Q. Sperm RNA code programmes the metabolic health of offspring. Nat Rev Endocrinol. 2019 Aug;15(8):489-498. doi: 10.1038/s41574-019-0226-2. Epub 2019 Jun 24.

  PMID: 31235802 BACKGROUND

• Vashisht A, Gahlay GK. Using miRNAs as diagnostic biomarkers for male infertility: opportunities and challenges. Mol Hum Reprod. 2020 Apr 24;26(4):199-214. doi: 10.1093/molehr/gaaa016.

  PMID: 32084276 BACKGROUND

• Alves MBR, Celeghini ECC, Belleannee C. From Sperm Motility to Sperm-Borne microRNA Signatures: New Approaches to Predict Male Fertility Potential. Front Cell Dev Biol. 2020 Aug 21;8:791. doi: 10.3389/fcell.2020.00791. eCollection 2020.

  PMID: 32974342 BACKGROUND

• Abu-Halima M, Hammadeh M, Backes C, Fischer U, Leidinger P, Lubbad AM, Keller A, Meese E. Panel of five microRNAs as potential biomarkers for the diagnosis and assessment of male infertility. Fertil Steril. 2014 Oct;102(4):989-997.e1. doi: 10.1016/j.fertnstert.2014.07.001. Epub 2014 Aug 6.

  PMID: 25108464 BACKGROUND

• Cui L, Fang L, Shi B, Qiu S, Ye Y. Spermatozoa micro ribonucleic acid-34c level is correlated with intracytoplasmic sperm injection outcomes. Fertil Steril. 2015 Aug;104(2):312-7.e1. doi: 10.1016/j.fertnstert.2015.05.003. Epub 2015 Jun 6.

  PMID: 26051092 BACKGROUND

• Hua M, Liu W, Chen Y, Zhang F, Xu B, Liu S, Chen G, Shi H, Wu L. Identification of small non-coding RNAs as sperm quality biomarkers for in vitro fertilization. Cell Discov. 2019 Apr 9;5:20. doi: 10.1038/s41421-019-0087-9. eCollection 2019. No abstract available.

  PMID: 30992999 BACKGROUND

MeSH Terms

Conditions

Infertility, Male

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Infertility; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Senior research scientist

Study Record Dates

• First Submitted: September 25, 2023
• First Posted: November 28, 2023
• Study Start: October 11, 2023
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: July 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)