Infertility Clinical Trial
— ReH-CPOfficial title:
Reproductive Health of Couples of Childbearing Age: a Community Based Prospective Cohort Study
NCT number | NCT04068428 |
Other study ID # | 201925201 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | July 26, 2019 |
Est. completion date | December 31, 2021 |
Verified date | March 2022 |
Source | Guangzhou Women and Children's Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Guangzhou Women and Children's Medical Center |
China,
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
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 |
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