A Cohort Study of Environmental Endocrine Disrupting Chemicals and Female Reproductive Health (PKU-ERC)

Adverse Effects and Mechanism of Environmental Endocrine Disrupting Chemicals on Female Reproductive health--the Peking University and Environment Reproductive Health Cohort

Infertility is a disease that seriously affects the physical and mental health of women of childbearing age. The incidence of infertility has been increasing in recent years. Studies have shown that the occurrence of infertility may be related to environmental endocrine disrupting substances. This project was designed to establish a cohort study on environmental endocrine disrupting substances and in vitro fertilization (IVF) treatment, collect blood, urine, semen, follicular fluid, granulosa cells, chorionic decidua biological specimens, and then follow up on the pregnancy outcomes. The concentration of disrupting substances was detected and then found the associations between environmental endocrine disrupting substances and female reproductive health.

Study Overview

• Status: Recruiting
• Conditions: IVF
• Intervention / Treatment: Other: there is no intervention in the study

• Study Type: Observational
• Enrollment (Anticipated): 2000

Contacts and Locations

• Study Contact: Name: Huan Shen, doctor; Phone Number: 86010-88324436; Email: rmivf@sina.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Recruiting
      • Peking University People's Hospital
      • Contact: Huan Shen, doctor; Phone Number: 86010-88324436; Email: rmivf@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All the couples intended to receive the treatment of IVF can be included in the study.

Description

Inclusion Criteria:

Clinical diagnosis of infertile patients undergoing IVF treatment

Exclusion Criteria:

Donor egg transplants excluded

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of eggs retrieved	the number of eggs retrieved in the process of in vitro fertilization (IVF)	immediately after the eggs retrieved
the number of available embryos	the number of available embryos in the process of IVF	1 week after the eggs retrieved
the clinical pregnancy rate	the clinical pregnancy rate in the process of IVF	4 weeks after the embryos transfer
the miscarriage rate	the miscarriage rate in the process of IVF	7 months after embryos transfer
the live birth rate	the live birth rate in the process of IVF	40 weeks after embryos transfer

Collaborators and Investigators

• Sponsor: Peking University People's Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2018
• Primary Completion (ANTICIPATED): December 1, 2022
• Study Completion (ANTICIPATED): December 1, 2022

Study Registration Dates

• First Submitted: April 19, 2022
• First Submitted That Met QC Criteria: May 12, 2022
• First Posted (ACTUAL): May 13, 2022

Study Record Updates

• Last Update Posted (ACTUAL): May 13, 2022
• Last Update Submitted That Met QC Criteria: May 12, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: PKUPHIVF001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No