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
Introduction Despite the global prevalence of low fertility rates, male contributions to fertility and reproductive health outcomes have been understudied. This study aims to investigate the male contribution to fertility and explore the underlying biological mechanisms. Specifically, we aim to (1)...
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BMJ Publishing Group
2025-01-01
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| author | Fabian Yap See Ling Loy Yin Bun Cheung Jerry Kok Yen Chan Keith Godfrey Chee Wai Ku Jun Wei Pek Melissa D/O Tharmalingam Durgahshree Melinda Chan Yie Hou Lee |
| author_facet | Fabian Yap See Ling Loy Yin Bun Cheung Jerry Kok Yen Chan Keith Godfrey Chee Wai Ku Jun Wei Pek Melissa D/O Tharmalingam Durgahshree Melinda Chan Yie Hou Lee |
| author_sort | Fabian Yap |
| collection | DOAJ |
| description | Introduction Despite the global prevalence of low fertility rates, male contributions to fertility and reproductive health outcomes have been understudied. This study aims to investigate the male contribution to fertility and explore the underlying biological mechanisms. Specifically, we aim to (1) identify male factors associated with successful pregnancy, (2) develop a fertility index incorporating modifiable factors for both males and females to predict pregnancy rate and (3) explore the relationship of male modifiable factors with semen parameters and molecular characteristics.Methods and analysis We will conduct an unmatched case-control study involving 240 couples with impaired male fertility (cases) and 240 couples with normal male fertility (controls). Between July 2024 and June 2026, we will recruit 480 eligible couples from KK Women’s and Children’s Hospital, Singapore. Male and female participants will complete questionnaires on sociodemographics, general health and lifestyle factors, and their anthropometry and body fat composition will be measured. Blood and semen samples from the male participants will be collected for biochemical, molecular and semen analyses. Predictive male factors will be identified using the least absolute shrinkage and selection operator method, accounting for female factors. We will construct a logistic regression model incorporating both male and female factors to derive a fertility index, which will be evaluated using cross-validation on subsets of the study population. Multivariable linear regression will be used to explore relationships between male modifiable exposures and semen parameters.Ethics and dissemination The study protocol has received approval from the Centralised Institutional Review Board of SingHealth (2024/2120), Singapore. Participants will provide written informed consent. Study results will be disseminated through conferences and peer-reviewed scientific journals.Trial registration number NCT06293235. |
| format | Article |
| id | doaj-art-54e61b0be00e489bb77d480e993d0251 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-54e61b0be00e489bb77d480e993d02512025-01-17T23:55:08ZengBMJ Publishing GroupBMJ Open2044-60552025-01-0115110.1136/bmjopen-2024-088143Investigating male factors and their relationships with reproductive health outcomes: a case-control study protocol for Towards Optimal Fertility, Fathering, and Fatherhood studY (TOFFFY) in SingaporeFabian Yap0See Ling Loy1Yin Bun Cheung2Jerry Kok Yen Chan3Keith Godfrey4Chee Wai Ku5Jun Wei Pek6Melissa D/O Tharmalingam Durgahshree7Melinda Chan8Yie Hou Lee910 Department of Paediatrics, KK Women`s and Children`s Hospital, Singapore1 Department of Reproductive Medicine, KK Women`s and Children`s Hospital, Singapore5 Program in Health Services and Systems Research and Centre for Quantitative Medicine, Duke-NUS Medical School, Singapore1 Department of Reproductive Medicine, KK Women`s and Children`s Hospital, Singapore8 MRC Lifecourse Epidemiology Unit, University of Southampton and Southampton University Hospitals NHS Trust, Southampton, UK1 Department of Reproductive Medicine, KK Women`s and Children`s Hospital, Singapore3 Temasek Life Sciences Laboratory, Singapore1 Department of Reproductive Medicine, KK Women`s and Children`s Hospital, Singapore1 Department of Reproductive Medicine, KK Women`s and Children`s Hospital, Singapore2 Duke-NUS Medical School, SingaporeIntroduction Despite the global prevalence of low fertility rates, male contributions to fertility and reproductive health outcomes have been understudied. This study aims to investigate the male contribution to fertility and explore the underlying biological mechanisms. Specifically, we aim to (1) identify male factors associated with successful pregnancy, (2) develop a fertility index incorporating modifiable factors for both males and females to predict pregnancy rate and (3) explore the relationship of male modifiable factors with semen parameters and molecular characteristics.Methods and analysis We will conduct an unmatched case-control study involving 240 couples with impaired male fertility (cases) and 240 couples with normal male fertility (controls). Between July 2024 and June 2026, we will recruit 480 eligible couples from KK Women’s and Children’s Hospital, Singapore. Male and female participants will complete questionnaires on sociodemographics, general health and lifestyle factors, and their anthropometry and body fat composition will be measured. Blood and semen samples from the male participants will be collected for biochemical, molecular and semen analyses. Predictive male factors will be identified using the least absolute shrinkage and selection operator method, accounting for female factors. We will construct a logistic regression model incorporating both male and female factors to derive a fertility index, which will be evaluated using cross-validation on subsets of the study population. Multivariable linear regression will be used to explore relationships between male modifiable exposures and semen parameters.Ethics and dissemination The study protocol has received approval from the Centralised Institutional Review Board of SingHealth (2024/2120), Singapore. Participants will provide written informed consent. Study results will be disseminated through conferences and peer-reviewed scientific journals.Trial registration number NCT06293235.https://bmjopen.bmj.com/content/15/1/e088143.full |
| spellingShingle | Fabian Yap See Ling Loy Yin Bun Cheung Jerry Kok Yen Chan Keith Godfrey Chee Wai Ku Jun Wei Pek Melissa D/O Tharmalingam Durgahshree Melinda Chan Yie Hou Lee 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 |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| url | https://bmjopen.bmj.com/content/15/1/e088143.full |
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