NCT06293235

Towards Optimal Fertility, Fathering and Fatherhood studY

Investigating Male Factors and Their Relationships With Reproductive Health Outcomes in Singapore: Towards Optimal Fertility, Fathering and Fatherhood studY

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 960 (estimated)
• Sponsor: KK Women's and Children's Hospital · Other Government
• Sex: All
• Age: 21 Years – 49 Years
• Healthy volunteers: Accepted

Summary

This case-control study involving fertile and subfertile couples aims to identify male factors related to pregnancy likelihood, create a fertility index measure combining male and female factors to predict pregnancy likelihood, and examine how male factors relate to the semen physical and biological characteristics.

Detailed description

Paternal contributions to fertility and reproductive health outcomes have been understudied, despite promising evidence from animal studies. This study aims to investigate the male contribution to pregnancy likelihood and explore the underlying biological mechanisms. Specifically, the investigators aim to (1) identify male factors associated with pregnancy rate; (2) develop a fertility index combining modifiable factors for both males and females to predict pregnancy rate; and (3) explore the relationship of male modifiable factors with semen physical and molecular characteristics. This is a case-control study with 480 fertile and subfertile males (along with their female partners), recruited from KK Women's and Children's Hospital. The investigators will use questionnaires to collect data on socio-demographic characteristics, clinical, lifestyle, and environmental factors; analyze metabolic and stress biomarkers from blood samples; and measure semen parameters including sperm motility, density, morphology, volume, DNA fragmentation, DNA methylation, gene expression, and seminal plasma oxidative status. Findings from this proposed study will pave the way for developing lifestyle-based or medical interventions to enhance male and couple reproductive health, and potentially benefiting future offspring health.

Conditions

• Reproductive Issues
• Fertility Issues

Interventions

Type	Name	Description
OTHER	Lifestyle and metabolic indicators	Socio-demographics, health history, behavioural characteristics, environmental exposures, anthropometric measurements, body fat composition, metabolic and stress biomarkers, semen physical and molecular characteristics.

Timeline

• Start date: 2024-06-21
• Primary completion: 2027-03-01
• Completion: 2027-09-01
• First posted: 2024-03-05
• Last updated: 2026-03-20

Locations

1 site across 1 country: Singapore