NCT03679000

The Effect of Periconceptional Phthalates Exposure on Couples' Reproductive Health

Periconceptional Phthalates Exposure and Its Epigenetic Effect on Fertility, Embryo Development, and Neonatal Outcomes: a Prospective Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 2,122 (estimated)
• Sponsor: Tongji Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Environmental Exposure
• Infertility

Timeline

• Start date: 2018-12-01
• Primary completion: 2020-12-31
• Completion: 2021-12-31
• First posted: 2018-09-20
• Last updated: 2019-04-23

Locations

1 site across 1 country: China