Investigating Male Factors and Their Relationships With Reproductive Health Outcomes in Singapore: Towards Optimal Fertility, Fathering and Fatherhood studY
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Reproductive Issues
- Sponsor
- KK Women's and Children's Hospital
- Enrollment
- 960
- Locations
- 1
- Primary Endpoint
- Pregnancy rate
- Status
- Recruiting
- Last Updated
- last month
Overview
Brief 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.
Investigators
Loy See Ling
Junior Principal Investigator
KK Women's and Children's Hospital
Eligibility Criteria
Inclusion Criteria
- •Subfertile couples:
- •men aged ≥21-49 years
- •men with a female partner aged 21-39 years
- •couples who are not able to conceive for at least 12 months
- •couples who are Singapore citizen or permanent resident
- •Fertile couples:
- •men aged 21-49 years
- •men with a female partner aged 21-39 years
- •men with proven fertility defined as those female partners who are currently pregnant and with viable intrauterine pregnancy at gestational weeks of less or equal to 16 at the time of the study
- •couples with attempted time to conceive within 12 months to achieve this pregnancy or with unplanned pregnancy
Exclusion Criteria
- •Subfertile couples:
- •male infertility of a known aetiology including azoospermia, retrograde ejaculation, genetic disorders, cancer treatment, or testes trauma
- •female infertility diagnosis as confirmed by diagnostic imaging or having severe endometriosis
- •female partners with irregular menstrual cycle \>35 days
- •couples with known chromosomal abnormalities
- •Fertile couples:
- •couples who achieve pregnancy after oocyte or spermatozoa donation
- •couples with known chromosomal abnormalities
- •female partners with known uterine abnormalities
Outcomes
Primary Outcomes
Pregnancy rate
Time Frame: Up to 16 weeks of gestation
Defined by viable intrauterine pregnancy at gestational weeks of less or equal to 16 at the time of the study
Secondary Outcomes
- Sperm concentration(Up to 2 years)
- Sperm progressive motility(Up to 2 years)
- Oxidative stress(Through study completion, an average of 3 years)
- mRNA level(Through study completion, an average of 3 years)
- Sperm total motility(Up to 2 years)
- Total progressive motile sperm count(Up to 2 years)
- Double strand sperm DNA fragmentation(Up to 2 years)
- sncRNA level(Through study completion, an average of 3 years)
- Fertility index(Through study completion, an average of 3 years)
- Semen volume(Up to 2 years)
- Single strand sperm DNA fragmentation(Up to 2 years)
- DNA methylation(Through study completion, an average of 3 years)