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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04068428
Acronym
ReH-CP
Enrollment
2313
Registered
2019-08-28
Start date
2019-07-26
Completion date
2021-12-31
Last updated
2022-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility, Medical Care, Reproductive Health, Risk Factor, Time to Pregnancy

Keywords

Reproductive Health, Time to Pregnancy, Infertility, Risk Factor, Assisted Reproductive Technology, Prospective Cohort

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.

Interventions

None listed

Sponsors

Guangzhou Women and Children's Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Time to pregnancyFrom date of recruitment until the date of last menstrual period when conceived, assessed up to 1 yearAssessed by calculate the intervals between last menstrual period when conceived and the timing of termination of contraception.

Secondary

MeasureTime frameDescription
Prevalence of infertilityAfter 1 year of follow-upInfertility was defined according to the World Health Organization manual as failing to achieve pregnancy after at least 12 months of unprotected regular sexual intercourse.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026