Identifying Molecular Determinants of Infertility in Men (MODIFY)

NCT ID: NCT06147700

Last Updated: 2025-07-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-11

Study Completion Date

2024-06-30

Brief Summary

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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

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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.

Conditions

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Male Infertility

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

PROSPECTIVE

Study Groups

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Healthy fertile male

No intervention for this study.

No interventions assigned to this group

Healthy infertile male

No intervention for this study.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Institute for Human Development and Potential (IHDP), Singapore

OTHER

Sponsor Role lead

Responsible Party

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Candida Vaz

Principal Investigator, Senior research scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Human Development Research Centre (HDRC)

Singapore, , Singapore

Site Status

Countries

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Singapore

References

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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.

Reference Type BACKGROUND
PMID: 29732171 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29525406 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29564308 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22235670 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31235802 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32084276 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32974342 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25108464 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26051092 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30992999 (View on PubMed)

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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2023-085

Identifier Type: -

Identifier Source: org_study_id

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