Environmental ExposureNCT03679000
The Effect of Periconceptional Phthalates Exposure on Couples' Reproductive Health
An observational study of Environmental Exposure and Infertility, run by Tongji Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Environmental Exposure, Infertility
- How many people
- 2,122 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2018to 31 Dec 2021
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- Subjects in the primary part of the study
- ·Normal gender of men and women
- No genetic diseases or congenital diseases
- No family genetic history
- Normal sperm analysis for men
- Female age <35 years
Show all 14Show fewer
- ·Normal Ovarian function for women
- Normal endocrine function for women
- No uterine disease or abnormality
- The causes of infertility :
- Tubal factors
- Unexplained
- The protocol of controlled ovary hyperstimulation :
- A routine long-term protocol
Who cannot join
- Subjects with smoking or alcohol abuse in the past 3 months
- Patients with overweight or obesity (BMI ≥ 25)
- Embryos with chromosomal abnormalities confirmed by PGS
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Periconceptional Phthalates Exposure and Its Epigenetic Effect on Fertility, Embryo Development, and Neonatal Outcomes: a Prospective Study
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.
Read the 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.
- 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.
- 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.
- Measurements of phthalates metabolites in the biological samples.
- 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.
- Analyze the miRNA expression profiles of blastocyst culture medium.
- 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
- Keywords
- environmental exposure, epigenetic process, embryo development, infertility, cohort study
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phthalates exposure levels
Concentrations of phthalates in ng/ml
Measured: 12/2021
Secondary outcomes (3)
Exposure characteristics of phthalates
The exposure of different personal care products in weeks
Measured: 12/2021
Reproductive outcomes
The different reproductive outcomes in percent
Measured: 12/2021
The expression profiles of miRNA
The expression profiles of miRNA in different quantity
Measured: 12/2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2018
- Study start1 Dec 2018
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Environmental ExposureStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,122 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liyufeng, Tongji Hospital
- Investigators
- Yufeng Li, Doctor, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03679000
- Sponsor's protocol ID
- H0425
- Status last verified
- Apr 2019
- First submitted
- 10 Sep 2018
- Last updated
- 23 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 27067915Wang 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.
PubMed 26654563Wang 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.
PubMed 26087406Zeng 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.
PubMed 24632126Zeng 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.
PubMed 23454109
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Periconceptional Phthalates Exposure and Its Epigenetic Effect on Fertility, Embryo Development, and Neonatal Outcomes: a Prospective Study
- ClinicalTrials.gov ID
- NCT03679000
- Acronym / sponsor ID
- H0425
- Conditions
- Environmental Exposure, Infertility
- Keywords
- environmental exposure, epigenetic process, embryo development, infertility, cohort study
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,122 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 20 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
- 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.
- Measurements of phthalates metabolites in the biological samples.
- 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.
- Analyze the miRNA expression profiles of blastocyst culture medium.
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (14 listed)
- Subjects in the primary part of the study
- ·Normal gender of men and women
- Normal sperm analysis for men
- Female age <35 years
- ·Normal Ovarian function for women
Key exclusion criteria (3 listed)
- Subjects with smoking or alcohol abuse in the past 3 months
- Patients with overweight or obesity (BMI ≥ 25)
- Embryos with chromosomal abnormalities confirmed by PGS
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Phthalates exposure levels
Time frame: 12/2021
Concentrations of phthalates in ng/ml
3 secondary outcomes
Exposure characteristics of phthalates
Time frame: 12/2021
Reproductive outcomes
Time frame: 12/2021
The expression profiles of miRNA
Time frame: 12/2021
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2019.
- Background: PubMed 27067915Du 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.
- Background: PubMed 26654563Wang 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.
- Background: PubMed 26087406Wang 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.
- Background: PubMed 24632126Zeng 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.
- Background: PubMed 23454109Zeng 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yufeng Li, Doctor principal investigator
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Environmental Exposure and Infertility, run by Tongji Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yufeng Li, Doctor (027-83663351, yufengli64@tjh.tjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phthalates exposure levels (time frame: 12/2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03679000, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2019.