HIPAA Compliant
ISO 27001 CertifiedActively Recruiting
Led by KK Women's and Children's Hospital · Updated on 2026-03-20
960
Participants Needed
1
Research Sites
26 weeks
Total Duration
Researchers are investigating the role of male factors in fertility and reproductive health outcomes in this observational case-control study involving fertile and subfertile couples. The study aims to identify which male factors influence pregnancy likelihood, develop a combined fertility index from both male and female factors to predict pregnancy, and explore how male factors relate to physical and molecular characteristics of semen. This study involves 480 couples recruited from KK Womens and Childrens Hospital to better understand male contributions to reproductive success and underlying biological mechanisms. Participants include males aged 21 to 49 years and their female partners aged 21 to 39 years, divided into subfertile couples who have not conceived after at least 12 months and fertile couples with pregnancies up to 16 weeks gestation or unplanned pregnancies. Data collection involves questionnaires covering socio-demographics, clinical history, lifestyle, and environmental exposures. Biological samples such as blood are analyzed for metabolic and stress biomarkers, while semen samples are evaluated for parameters including motility, density, morphology, DNA fragmentation, methylation, gene expression, and oxidative status. Throughout the study, researchers will track pregnancy rates up to 16 weeks gestation and measure various semen and biomarker outcomes over an average of three years. Participants will complete questionnaires and provide samples to assess the relationships between male modifiable factors and fertility. The studys findings aim to inform potential lifestyle or medical interventions to improve reproductive health for men and couples. The total participation duration varies depending on the outcome measures, with some tracked for up to two years and others through study completion.
CONDITIONS
Towards Optimal Fertility, Fathering and Fatherhood studY
B
Benjarat Oh
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KK Women's and Children's Hospital
Lead Sponsor
You may qualify if you...
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Initial assessments over a few days
Participants provide socio-demographic data, clinical history, lifestyle and environmental information via questionnaires and undergo metabolic and stress biomarker assessments from blood samples. Semen samples are collected to measure physical and molecular characteristics.
1 to 2 visits depending on sample collection and assessments
Duration - Up to 3 years
Participants are monitored for reproductive health outcomes including pregnancy rate and semen parameters over time.
Periodic visits for follow-up assessments up to 3 years
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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Chee Wai Ku, Jun Wei Pek, Yin Bun Cheung...
https://pubmed.ncbi.nlm.nih.gov/39819913/KK Women's and Children's Hospital
Lead Sponsor
