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Reproductive Health of Couples of Childbearing Age: a Community Based Prospective Cohort Study (ReH-CP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04068428
Recruitment Status : Recruiting
First Posted : August 28, 2019
Last Update Posted : August 28, 2019
Sponsor:
Information provided by (Responsible Party):
Zehong Zhou, Guangzhou Women and Children's Medical Center

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.

Condition or disease
Reproductive Health Time to Pregnancy Infertility Risk Factor Medical Care

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.

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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Reproductive Health of Couples of Childbearing Age: a Community Based Prospective Cohort Study
Actual Study Start Date : July 31, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples Without DNA
Blood sample will be collected from participants who fail to conceive after 12 months of attempts.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04068428


Contacts
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Contact: Zehong Zhou, MD +8613318890706 rainbow_0706@163.com
Contact: Zehong Zhou, MD 0086 20 38366085 rainbow_1234@aliyun.com

Locations
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China, Guangdong
Guangzhou Women and Children's Medical Center Recruiting
Guangzhou, Guangdong, China, 510623
Contact: Zehong Zhou, MD    +8613318890706    rainbow_0706@163.com   
Tianhe District Maternal and Child Health Hospital Recruiting
Guangzhou, Guangdong, China, 510623
Contact: Zehong Zhou, MD    +8613318890706    rainbow_0706@163.com   
China, Hainan
Longhua District Maternal and Child Health Hospital Not yet recruiting
Haikou, Hainan, China, 570100
Contact: Zehong Zhou, MD    +8613318890706    rainbow_0706@163.com   
Qiongshan District Maternal and Child Health Hospital Not yet recruiting
Haikou, Hainan, China, 571100
Contact: Zehong Zhou, MD    +8613318890706    rainbow_0706@163.com   
Sponsors and Collaborators
Guangzhou Women and Children's Medical Center
Investigators
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Principal Investigator: Zehong Zhou, MD Guangzhou Women and Children's Medical Center, China
Publications:
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Responsible Party: Zehong Zhou, Principal Investigator, Guangzhou Women and Children's Medical Center
ClinicalTrials.gov Identifier: NCT04068428    
Other Study ID Numbers: 201925201
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zehong Zhou, Guangzhou Women and Children's Medical Center:
Reproductive Health
Time to Pregnancy
Infertility
Risk Factor
Assisted Reproductive Technology
Prospective Cohort
Additional relevant MeSH terms:
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Infertility
Genital Diseases, Male
Genital Diseases, Female