Towards Optimal Fertility, Fathering and Fatherhood studY
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age21-49
SponsorKK Women's and Children's Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial 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.
Trial design
Design model
Case-control
Time perspective
Cross-sectional
Treatments tested in this trial
Lifestyle and metabolic indicators
Other interventionSocio-demographics, health history, behavioural characteristics, environmental exposures, anthropometric measurements, body fat composition, metabolic and stress biomarkers, semen physical and molecular characteristics.
Treatment groups
960 Participants
are divided into 2 treatment groupsGroup A: Subfertile couples1 intervention
Group B: Fertile couples1 intervention
Trial outcomes
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
Time frame
Up to 16 weeks of gestationSecondary outcomes
1
Fertility index
Defined by a composite index score derived from both male and female predictive factors
Time frame
Through study completion, an average of 3 years2
Oxidative stress
Defined by oxidative status measured from blood and semen samples using the micro-NMR
Time frame
Through study completion, an average of 3 years3
Semen volume
Assessed by semen analysis in ml
Time frame
Up to 2 years4
Sperm concentration
Assessed by semen analysis in million/ml
Time frame
Up to 2 yearsOther outcomes
1
Sperm morphology
Assessed by semen analysis
Time frame
Up to 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov