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

NCT04068428 | Completed DMC

• 1 other identifier: 201925201
• Study Type: observational
• Target: 2,313
• Locations: 1 country
• Sites: 4

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Prevalence of infertility

  After 1 year of follow-up

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• Guangzhou Women and Children's Medical Center: lead

Study Sites (4)

Guangzhou Women and Children's Medical Center

Guangzhou, Guangdong, 510623, China

Location

Tianhe District Maternal and Child Health Hospital

Guangzhou, Guangdong, 510623, China

Location

Longhua District Maternal and Child Health Hospital

Haikou, Hainan, 570100, China

Location

Qiongshan District Maternal and Child Health Hospital

Haikou, Hainan, 571100, China

Location

Related 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.

  PMID: 29030908 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sample will be collected from participants who fail to conceive after 12 months of attempts.

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Zehong Zhou, MD

  Guangzhou Women and Children's Medical Center, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 20, 2019
• First Posted: August 28, 2019
• Study Start: July 26, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2021
• Last Updated: March 16, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)