Exploring male factors affecting fertility and pregnancy likelihood
Investigating Male Factors and Their Relationships With Reproductive Health Outcomes in Singapore: Towards Optimal Fertility, Fathering and Fatherhood studY
This study is trying to find out how different male factors affect the chances of getting pregnant for couples, to help create a tool that predicts pregnancy rates and improve reproductive health.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 960 (estimated) |
| Ages | 21 Years to 49 Years |
| Sex | All |
| Sponsor | KK Women's and Children's Hospital Government |
| Locations | 1 site (Singapore) |
| Trial ID | NCT06293235 on ClinicalTrials.gov |
What this trial studies
This observational case-control study involves 480 fertile and subfertile couples to identify male factors that influence pregnancy likelihood. The study aims to create a fertility index that combines both male and female factors to predict pregnancy rates and examines how male factors relate to semen characteristics. Data will be collected through questionnaires and biological samples, focusing on lifestyle, environmental factors, and semen analysis. The findings could lead to lifestyle-based or medical interventions to improve reproductive health for couples.
Who should consider this trial
Good fit: Ideal candidates include men aged 21-49 with a female partner aged 21-39, either subfertile couples unable to conceive for at least 12 months or fertile couples with a current viable pregnancy.
Not a fit: Patients with known male infertility causes or female infertility diagnoses may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of male fertility factors and improve pregnancy outcomes for couples struggling to conceive.
How similar studies have performed: While the male contribution to fertility has been less studied, there is emerging evidence from animal studies, suggesting that this approach may yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion 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 * 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
Where this trial is running
Singapore
- KK Women's and Children's Hospital — Singapore, Singapore (Recruiting)
Study contacts
- Principal investigator: See Ling Loy, PhD — KK Women's and Children's Hospital
- Study coordinator: Benjarat Oh
- Email: benjarat.oh@kkh.com.sg
- Phone: 63948105
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.