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

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.

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Key information

Conditions

Reproductive Health Genital Diseases Infertility Medical Care Risk Factor Time to Pregnancy Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Guangzhou Women and Children's Medical Center, Guangzhou, Guangdong, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Time to pregnancy

Time frame: 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 outcomes

Prevalence of infertility

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Guangzhou Women and Children's Medical Center

Other

Registry information

Acronym: ReH-CP

Important dates

Study start: 2019
Primary completion: 2020
Study completion: 2021
First posted: Aug 28, 2019
Registry last updated: Mar 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed