Towards Optimal Fertility, Fathering and Fatherhood studY (TOFFFY)

KK Women's and Children's Hospital

Status: Enrolling

Conditions: Reproductive Issues; Fertility Issues

Treatments: Other: Lifestyle and metabolic indicators

Study type: Observational

Funder types: Other

Identifiers

NCT06293235

2024/2120

Details and patient eligibility

About

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.

Full 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.

Enrollment: 960 estimated patients

Sex: All

Ages: 21 to 49 years old

Volunteers: Accepts Healthy Volunteers

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
• couples who are Singapore citizen or permanent resident

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

Trial design

960 participants in 2 patient groups

Subfertile couples

Description:

Couples who are not able to conceive for at least 12 months with female partners without infertility diagnosis.

Treatment:

Other: Lifestyle and metabolic indicators

Fertile couples

Description:

Couples with attempted time to conceive within 12 months to achieve this pregnancy or with unplanned pregnancy, with female partners who are currently pregnant with viable intrauterine pregnancy.

Treatment:

Other: Lifestyle and metabolic indicators