Clinical trial NCT06147700: Identifying Molecular Determinants of Infertility in Men (MODIFY)
Official title: Identifying Molecular Determinants of Infertility in Men (MODIFY)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Male Infertility
Lead sponsor: Institute for Human Development and Potential (IHDP), Singapore
Sponsor class: OTHER
First posted: 2023-11-28
Enrollment: 100
Sex: MALE
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy male in the general population

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.

Detailed description: The goal of the study is to identify small non-coding RNA signatures of infertility in men through the comparison of sperm sncRNA profiles from around 100 men (21-50 years of age). The participants will be classified into fertile and infertile groups by the conventional method.

Through the project, the investigator intends to understand the underlying mechanisms of idiopathic infertility. By utilizing semen as liquid biopsy, through sperm sncRNA profiling and comparison (infertile vs fertile). The investigator proposes to identify the sncRNA (miRNAs, piRNAs and tRFs) as biomarkers of infertility.

The investigator proposes to generate a validated signature of sncRNAs that will help in selecting high quality sperms for IVF.

Eligibility criteria: Inclusion Criteria

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

Exclusion Criteria

* 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

Primary outcomes:
measure: Semen/Sperm quantity analysis
timeFrame: 1 week
measure: Semen/Sperm quality analysis
timeFrame: 1 week
measure: Fertility classification
timeFrame: 1 week
measure: Sperm RNA extraction and sequencing
timeFrame: 3 months
Secondary outcomes:
measure: Expression profiling of sncRNA
timeFrame: 3-6 months
measure: Comparison of the expression profiles
timeFrame: 3-6 months
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Human Development Research Centre (HDRC)
Study officials:
References:
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citation: 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.
citation: 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.
citation: 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.
citation: 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.