Fertility Issues Clinical Trial
— TOFFFYOfficial title:
Investigating Male Factors and Their Relationships With Reproductive Health Outcomes in Singapore: Towards Optimal Fertility, Fathering and Fatherhood studY
NCT number | NCT06293235 |
Other study ID # | 2024/2120 |
Secondary ID | |
Status | Not yet recruiting |
Phase | |
First received | |
Last updated | |
Start date | July 2024 |
Est. completion date | March 2027 |
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.
Status | Not yet recruiting |
Enrollment | 960 |
Est. completion date | March 2027 |
Est. primary completion date | June 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 21 Years to 49 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
KK Women's and Children's Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Sperm morphology | Assessed by semen analysis | Up to 2 years | |
Primary | 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 | Fertility index | Defined by a composite index score derived from both male and female predictive factors | Through study completion, an average of 3 years | |
Secondary | Oxidative stress | Defined by oxidative status measured from blood and semen samples using the micro-NMR | Through study completion, an average of 3 years | |
Secondary | Semen volume | Assessed by semen analysis in ml | Up to 2 years | |
Secondary | Sperm concentration | Assessed by semen analysis in million/ml | Up to 2 years | |
Secondary | Sperm total motility | Assessed by semen analysis in percent | Up to 2 years | |
Secondary | Sperm progressive motility | Assessed by semen analysis in percent | Up to 2 years | |
Secondary | Total progressive motile sperm count | measured by multiplying the semen volume (ml) by sperm concentration (million/ml) and the percentage of progressively motile sperm | Up to 2 years | |
Secondary | Single strand sperm DNA fragmentation | Measured by the AI-powered semen analyzer | Up to 2 years | |
Secondary | Double strand sperm DNA fragmentation | Measured by the AI-powered semen analyzer | Up to 2 years | |
Secondary | mRNA level | From blood and semen samples through transcriptomics analysis | Through study completion, an average of 3 years | |
Secondary | sncRNA level | From blood and semen samples through transcriptomics analysis | Through study completion, an average of 3 years | |
Secondary | DNA methylation | From blood and semen samples through bisulfite sequencing | Through study completion, an average of 3 years |
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