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

Infertility Clinical Trial

— ReH-CP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04068428
• Other study ID #: 201925201
• Status: Completed
• Start date: July 26, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: March 2022
• Source: Guangzhou Women and Children's Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2313
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
China	Guangzhou Women and Children's Medical Center	Guangzhou	Guangdong
China	Tianhe District Maternal and Child Health Hospital	Guangzhou	Guangdong
China	Longhua District Maternal and Child Health Hospital	Haikou	Hainan
China	Qiongshan District Maternal and Child Health Hospital	Haikou	Hainan

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou Women and Children's Medical Center

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to pregnancy	Assessed by calculate the intervals between last menstrual period when conceived and the timing of termination of contraception.	From date of recruitment until the date of last menstrual period when conceived, assessed up to 1 year
Secondary	Prevalence of infertility	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.	After 1 year of follow-up