Clinical trial NCT04068428: Reproductive Health of Couples of Childbearing Age: a Community Based Prospective Cohort Study
Official title: Reproductive Health of Couples of Childbearing Age: a Community Based Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Reproductive Health
Time to Pregnancy
Infertility
Risk Factor
Medical Care
Keywords: Reproductive Health
Time to Pregnancy
Infertility
Risk Factor
Assisted Reproductive Technology
Prospective Cohort
Lead sponsor: Guangzhou Women and Children's Medical Center
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 2313
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Couples of childbearing age from the cites of National Free Pre-conception Check-up Projects (NFPCP) in city of Guangzhou in Guangdong Province, or the city of Haikou in Hainan Province, will be recruited.

Brief summary: This community based prospective cohort study was established to investigate the fecundability of couples of childbearing age. Data are collected regarding age, body mass index, education, menstrual regularity as well as childbearing history. Results of routine examination of leucorrhea, blood glucose, liver function of the female spouse, and semen analysis of the male spouse are obtained from the National Free Pre-conception Check-up Projects (NFPCP) in China. Couples recruited will be followed every 6 months for at least 1 year, and their time to pregnancy as well as behavior of seeking medical care would be recorded. Blood sample and/or information of antral follicle count would be collected from participants who fail to conceive after 12 months of attempts.

Detailed description: Infertility is a heavy burden on families, with important implications for individuals and public health. In the last decades, the trend of delaying marriage and childbearing has further exacerbated the burden of infertility. From February 2010 to November 2011, a large-scale population-based cross-sectional study was conducted in northern and eastern China. It was reported that the overall prevalence of infertility was 15.5% among women 'at risk' of pregnancy, and 25.0% among women attempting to become pregnant in China. The prevalence of infertility was surprisingly high and aroused our great attention. To further explore the fecundability and associated risk factors in current China, this community based prospective cohort study was established. Recruitment will be performed at cites of National Free Pre-conception Check-up Projects (NFPCP). Besides of the information of sociodemographic characteristics and childbearing history of couples, their results of check-ups will also be obtained. By regular follow-ups, valid data of time to pregnancy will be collected. A prospective cohort would provide an opportunity to reveal the incidence of infertility, and explore the underlying risk factors of infertility, as well as the demand of assisted reproductive technology.

Eligibility criteria: Inclusion Criteria:

* Couples who finish the national free pre-conception check-up
* Couples who agree to receive follow-ups every half year for at least 1 year

Exclusion Criteria:

* None

Primary outcomes:
measure: Time to pregnancy
timeFrame: From date of recruitment until the date of last menstrual period when conceived, assessed up to 1 year
Secondary outcomes:
measure: Prevalence of infertility
timeFrame: After 1 year of follow-up
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangzhou Women and Children's Medical Center
state: Guangdong
city: Guangzhou
country: China
facility: Tianhe District Maternal and Child Health Hospital
state: Guangdong
city: Haikou
country: China
facility: Longhua District Maternal and Child Health Hospital
state: Hainan
city: Haikou
country: China
facility: Qiongshan District Maternal and Child Health Hospital
state: Hainan
Study officials:
affiliation: Guangzhou Women and Children's Medical Center, China
name: Zehong Zhou, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhou Z, Zheng D, Wu H, Li R, Xu S, Kang Y, Cao Y, Chen X, Zhu Y, Xu S, Chen ZJ, Mol BW, Qiao J. Epidemiology of infertility in China: a population-based study. BJOG. 2018 Mar;125(4):432-441. doi: 10.1111/1471-0528.14966. Epub 2017 Dec 28.