NCT05373290

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

April 19, 2022

Completed
24 days until next milestone

First Posted

Study publicly available on registry

May 13, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

May 13, 2022

Status Verified

May 1, 2022

Enrollment Period

4.9 years

First QC Date

April 19, 2022

Last Update Submit

May 12, 2022

Conditions

Outcome Measures

Primary Outcomes (5)

  • 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

Interventions

there is no intervention in the study

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Clinical diagnosis of infertile patients undergoing IVF treatment

You may not qualify if:

  • Donor egg transplants excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, China

RECRUITING

Related Publications (1)

  • Wang H, Liang Y, Dong X, Fu M, Wang Y, Wang Y, Han H, Wang M, Zuo Y, Zhang S, Shen H, Han F, Gao F. Association between snoring and in vitro fertilization outcomes among infertile women. Sleep Med. 2025 Apr;128:74-81. doi: 10.1016/j.sleep.2025.01.013. Epub 2025 Jan 21.

Biospecimen

Retention: SAMPLES WITHOUT DNA

the urine, blood, follicular fluid,semen,villous tissue and placenta

Central Study Contacts

Huan Shen, Doctor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Reproductive Medicine Center

Study Record Dates

First Submitted

April 19, 2022

First Posted

May 13, 2022

Study Start

January 1, 2018

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

May 13, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations