Reproductive Health of Couples of Childbearing Age: a Community Based Prospective Cohort Study

Completed

• Conditions: Time to Pregnancy; Reproductive Health; Medical Care; Infertility; Risk Factor

• Registration Number: NCT04068428
• Lead Sponsor: Guangzhou Women and Children's Medical Center

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.

Study Timeline

• Study Start: 2019-07-26
• Study First Submitted: 2019-08-20
• Study First Submitted QC: 2019-08-23
• Study First Posted: 2019-08-28
• Primary Completion: 2020-12-31
• Study Completion: 2021-12-31
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-14
• Last Update Posted: 2022-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2313

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to pregnancy	From date of recruitment until the date of last menstrual period when conceived, assessed up to 1 year	Assessed by calculate the intervals between last menstrual period when conceived and the timing of termination of contraception.

Secondary Outcome Measures

Name	Time	Method
Prevalence of infertility	After 1 year of follow-up	Infertility was defined according to the World Health Organization manual as failing to achieve pregnancy after at least 12 months of unprotected regular sexual intercourse.

Trial Locations

Locations (4)

Longhua District Maternal and Child Health Hospital; 🇨🇳 Haikou, Hainan, China

Qiongshan District Maternal and Child Health Hospital; 🇨🇳 Haikou, Hainan, China

Guangzhou Women and Children's Medical Center; 🇨🇳 Guangzhou, Guangdong, China

Tianhe District Maternal and Child Health Hospital; 🇨🇳 Guangzhou, Guangdong, China