Reproductive HealthReH-CPNCT04068428
Reproductive Health of Couples of Childbearing Age: a Community Based Prospective Cohort Study
An observational study of Reproductive Health and Time to Pregnancy, run by Guangzhou Women and Children's Medical Center at 4 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Reproductive Health, Time to Pregnancy, Infertility
- How many people
- 2,313 participants
- Where
- 4 sitesChina
- Study dates
- 26 Jul 2019to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Couples of childbearing age from the cites of National Free Pre-conception Check-up Projects (NFPCP) in city of Guangzhou in Guangdong Province, or the city of Haikou in Hainan Province, will be recruited.
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
4 sites in 1 country.
China4 sites
Guangzhou Women and Children's Medical Center
Guangzhou, Guangdong, 510623
Tianhe District Maternal and Child Health Hospital
Guangzhou, Guangdong, 510623
Longhua District Maternal and Child Health Hospital
Haikou, Hainan, 570100
Qiongshan District Maternal and Child Health Hospital
Haikou, Hainan, 571100
About this 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.
Read the 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.
- Conditions
- Reproductive Health, Time to Pregnancy, Infertility, Risk Factor, Medical Care
- Keywords
- Reproductive Health, Time to Pregnancy, Infertility, Risk Factor, Assisted Reproductive Technology, Prospective Cohort
- Medical subject headings
- Infertility
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to pregnancy
Assessed by calculate the intervals between last menstrual period when conceived and the timing of termination of contraception.
Measured: From date of recruitment until the date of last menstrual period when conceived, assessed up to 1 year
Secondary outcomes (1)
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.
Measured: After 1 year of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start26 Jul 2019
- Primary completion31 Dec 2020
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Reproductive HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,313 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangzhou Women and Children's Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zehong Zhou, Guangzhou Women and Children's Medical Center
- Investigators
- Zehong Zhou, MD, Principal investigator, Guangzhou Women and Children's Medical Center, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04068428
- Sponsor's protocol ID
- 201925201
- Acronym
- ReH-CP
- Status last verified
- Mar 2022
- First submitted
- 20 Aug 2019
- Last updated
- 16 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29030908
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reproductive Health of Couples of Childbearing Age: a Community Based Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT04068428
- Acronym / sponsor ID
- ReH-CP / 201925201
- Conditions
- Reproductive Health, Time to Pregnancy, Infertility, Risk Factor, Medical Care
- Keywords
- Reproductive Health, Time to Pregnancy, Infertility, Risk Factor, Assisted Reproductive Technology, Prospective Cohort
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,313 participants (actual)
- Lead sponsor
- Guangzhou Women and Children's Medical CenterUniversity, hospital or other
- Study start
- 26 Jul 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 28 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Couples of childbearing age from the cites of National Free Pre-conception Check-up Projects (NFPCP) in city of Guangzhou in Guangdong Province, or the city of Haikou in Hainan Province, will be recruited.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Prevalence of infertility
Time frame: After 1 year of follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2022.
- Background: PubMed 29030908Zhou 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zehong Zhou, MD principal investigator
Guangzhou Women and Children's Medical Center, China
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Reproductive Health and Time to Pregnancy, run by Guangzhou Women and Children's Medical Center at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to pregnancy (time frame: From date of recruitment until the date of last menstrual period when conceived, assessed up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04068428, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2022.