The Effect of Periconceptional Phthalates Exposure on Couples' Reproductive Health

• Conditions: Environmental Exposure; Infertility

• Registration Number: NCT03679000
• Lead Sponsor: Tongji Hospital

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.

Detailed Description

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

1. All enrolled couples will be needed to sign an informed consent and complete a questionnaire for collecting information about demographics, life-style, and medical and reproductive histories.

2. Biological samples will be collected from the participants to measure phthalates metabolites in order to evaluate the exposure of single person or the couple in different time phase.The samples include urine, blood that will be left after the hormones measurement for both spouses. The follicular fluid will be obtained from females on the day of oocyte retrieval. The left sperm samples after sperm analysis will be obtained from men. In the reproductive center of Tongji Hospital, hormone measurement for women and sperm analysis for men are required for the In vitro fertilization and embryo transfer in order to evaluate the fertility of couples.And the blastocyst culture medium will be obtained from couples after blastocyst transfer. All samples will be stored at -80℃ until further analysis.

3. Measurements of phthalates metabolites in the biological samples.

4. Collecting data from electronic medical records and follow-up.The basic information, clinical data and reproductive outcomes of the subjects will be collected by reviewing the electronic medical charts, including the height, weight, basic hormone levels, stimulation protocol and time, insemination protocol, fertilization rate, cleavage rate, excellent embryo rate, blastocyst formation rate, clinical pregnancy rate, as well as live birth rate，the newborns' height, weight, and gestational age, etc.

5. Analyze the miRNA expression profiles of blastocyst culture medium.

6. Statistical analysis. The investigators will analyze the association between the couples' phthalates exposure levels and the reproductive outcomes, and explore the association among periconceptional phthalates exposure, epigenetic changes and reproductive outcomes.

Study Timeline

• Study First Submitted: 2018-09-10
• Study First Submitted QC: 2018-09-18
• Study First Posted: 2018-09-20
• Study Start: 2018-12-01
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-21
• Last Update Posted: 2019-04-23
• Primary Completion: 2020-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2122

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Phthalates exposure levels	12/2021	Concentrations of phthalates in ng/ml

Secondary Outcome Measures

Name	Time	Method
Exposure characteristics of phthalates	12/2021	The exposure of different personal care products in weeks
Reproductive outcomes	12/2021	The different reproductive outcomes in percent
The expression profiles of miRNA	12/2021	The expression profiles of miRNA in different quantity

Trial Locations

Locations (1)

Tongji Hospital; 🇨🇳 Wuhan, Hubei, China