Towards Optimal Fertility, Fathering and Fatherhood studY

NCT06293235 | Recruiting

• 1 other identifier: MOH-001530-01
• Study Type: observational
• Target: 960
• Locations: 1 country
• Sites: 1

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.

Conditions

Reproductive Issues; Fertility Issues

Keywords

Male; Risk factor; Lifestyle; Semen analysis; Epigenetic; Oxidative stress; DNA fragmentation

Outcome Measures

Primary Outcomes (1)

• Pregnancy rate

  Defined by viable intrauterine pregnancy at gestational weeks of less or equal to 16 at the time of the study

  Up to 16 weeks of gestation

Secondary Outcomes (12)

• Fertility index

  Through study completion, an average of 3 years

• Oxidative stress

  Through study completion, an average of 3 years

• Semen volume

  Up to 2 years

• Sperm concentration

  Up to 2 years

• Sperm total motility

  Up to 2 years

Other Outcomes (1)

• Sperm morphology

  Up to 2 years

Study Arms (2)

Subfertile couples

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

Other: Lifestyle and metabolic indicators

Fertile couples

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.

Other: Lifestyle and metabolic indicators

Interventions

Lifestyle and metabolic indicators OTHER

Socio-demographics, health history, behavioural characteristics, environmental exposures, anthropometric measurements, body fat composition, metabolic and stress biomarkers, semen physical and molecular characteristics.

Also known as: Semen quality and characteristics

Fertile couples; Subfertile couples

Eligibility Criteria

• Age: 21 Years - 49 Years
• Gender Eligibility Details: Based on biological sex identity for males and females
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The subfertile couples will be recruited from the infertility clinics, while the fertile couples will be recruited from the antenatal clinics. Both groups will also be recruited from on-going preconception and pregnancy programs in the hospital.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• KK Women's and Children's Hospital: lead

Study Sites (1)

KK Women's and Children's Hospital

Singapore, 229899, Singapore

RECRUITING

Related Publications (1)

• Ku CW, Pek JW, Cheung YB, Tharmalingam Durgahshree MD, Chan M, Lee YH, Godfrey K, Yap F, Chan JKY, Loy SL. Investigating male factors and their relationships with reproductive health outcomes: a case-control study protocol for Towards Optimal Fertility, Fathering, and Fatherhood studY (TOFFFY) in Singapore. BMJ Open. 2025 Jan 15;15(1):e088143. doi: 10.1136/bmjopen-2024-088143.

  PMID: 39819913 DERIVED

MeSH Terms

Conditions

Infertility

Interventions

Semen Analysis; Amino Acid Motifs

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Protein Structural Elements; Protein Conformation; Molecular Conformation; Molecular Structure; Biochemical Phenomena; Chemical Phenomena; Protein Structure, Secondary

Study Officials

• See Ling Loy, PhD

  KK Women's and Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Benjarat Oh

CONTACT

63948105; benjarat.oh@kkh.com.sg

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Junior Principal Investigator

Study Record Dates

• First Submitted: February 20, 2024
• First Posted: March 5, 2024
• Study Start: June 21, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: March 20, 2026

Record last verified: 2026-03

Locations

SG (1)