NCT03679000

Brief Summary

The study is a prospective cohort study, which is aiming to explore periconceptional phthalates exposure and its potential epigenetic effect on fertility, embryo development, and neonatal outcomes.

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
2,122

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2018

Typical duration 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

First Submitted

Initial submission to the registry

September 10, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 20, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2018

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

April 23, 2019

Status Verified

April 1, 2019

Enrollment Period

2.1 years

First QC Date

September 10, 2018

Last Update Submit

April 21, 2019

Conditions

Environmental ExposureInfertility

Keywords

environmental exposureepigenetic processembryo developmentinfertilitycohort study

Outcome Measures

Primary Outcomes (1)

  • Phthalates exposure levels

    Concentrations of phthalates in ng/ml

    12/2021

Secondary Outcomes (3)

  • Exposure characteristics of phthalates

    12/2021

  • Reproductive outcomes

    12/2021

  • The expression profiles of miRNA

    12/2021

Study Arms (1)

The reproductive health of couples

The study is a prospective cohort study, and its participants are childbearing couples who are seeking assisted reproductive technologies for having a baby in the reproductive center in Tongji Hospital.The study is a observational study.

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The study population is a group of childbearing couples who are seeking assisted reproductive technologies for having a baby in the reproductive center in Tongji Hospital.

You may not qualify if:

  • Occupational exposures
  • Couples living in separate places
  • Congenital diseases
  • Congenital azoospermia
  • Ejaculation dysfunction
  • Family history of genetic diseases
  • Acquired diseases
  • Genitourinary infections
  • Mumps
  • Endocrine diseases
  • Sexually transmitted diseases
  • Hyperthyroidism
  • Liver failure
  • Renal failure
  • Neurological diseases
  • +53 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tongji Hospital

Wuhan, Hubei, China

RECRUITING

Related Publications (5)

  • Du YY, Fang YL, Wang YX, Zeng Q, Guo N, Zhao H, Li YF. Follicular fluid and urinary concentrations of phthalate metabolites among infertile women and associations with in vitro fertilization parameters. Reprod Toxicol. 2016 Jun;61:142-50. doi: 10.1016/j.reprotox.2016.04.005. Epub 2016 Apr 8.

    PMID: 27067915BACKGROUND

  • Wang YX, Zeng Q, Sun Y, You L, Wang P, Li M, Yang P, Li J, Huang Z, Wang C, Li S, Dan Y, Li YF, Lu WQ. Phthalate exposure in association with serum hormone levels, sperm DNA damage and spermatozoa apoptosis: A cross-sectional study in China. Environ Res. 2016 Oct;150:557-565. doi: 10.1016/j.envres.2015.11.023. Epub 2015 Dec 3.

    PMID: 26654563BACKGROUND

  • Wang YX, You L, Zeng Q, Sun Y, Huang YH, Wang C, Wang P, Cao WC, Yang P, Li YF, Lu WQ. Phthalate exposure and human semen quality: Results from an infertility clinic in China. Environ Res. 2015 Oct;142:1-9. doi: 10.1016/j.envres.2015.06.010. Epub 2015 Jun 15.

    PMID: 26087406BACKGROUND

  • Zeng Q, Chen YZ, Xu L, Chen HX, Luo Y, Li M, Yue J, Liu AL, Li YF, Lu WQ. Evaluation of exposure to trihalomethanes in tap water and semen quality: a prospective study in Wuhan, China. Reprod Toxicol. 2014 Jul;46:56-63. doi: 10.1016/j.reprotox.2014.03.005. Epub 2014 Mar 13.

    PMID: 24632126BACKGROUND

  • Zeng Q, Li M, Xie SH, Gu LJ, Yue J, Cao WC, Zheng D, Liu AL, Li YF, Lu WQ. Baseline blood trihalomethanes, semen parameters and serum total testosterone: a cross-sectional study in China. Environ Int. 2013 Apr;54:134-40. doi: 10.1016/j.envint.2013.01.016. Epub 2013 Feb 26.

    PMID: 23454109BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Urine,serum, blastocyst culture medium for both spouse. Sperm for men. Follicular fluid for women.

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Yufeng Li, Doctor

    Tongji Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yufeng Li, Doctor

CONTACT

027-83663351yufengli64@tjh.tjmu.edu.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 10, 2018

First Posted

September 20, 2018

Study Start

December 1, 2018

Primary Completion

December 31, 2020

Study Completion

December 31, 2021

Last Updated

April 23, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

The reason that we do not plan to share IPD is that each participant enrolled in our study wil signed an informed consent.In the informed consent, we pledged that all information of participants will be kept strictly confidential.

Locations

CN(1)