IVFPKU-ERCNCT05373290
A Cohort Study of Environmental Endocrine Disrupting Chemicals and Female Reproductive Health
An observational study of IVF, run by Peking University People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- IVF
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to Dec 2022
- 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 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Study population: All the couples intended to receive the treatment of IVF can be included in the study.
Who may be able to join
- Clinical diagnosis of infertile patients undergoing IVF treatment
Who cannot join
- Donor egg transplants excluded
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality
Huan Shen, doctor, 86010-88324436, rmivf@sina.com
About this study
Official title: Adverse Effects and Mechanism of Environmental Endocrine Disrupting Chemicals on Female Reproductive health--the Peking University and Environment Reproductive Health Cohort
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.
- Conditions
- IVF
- Being tested
- there is no intervention in the study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
there is no intervention in the studyOther
there is no intervention in the study
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of eggs retrieved
the number of eggs retrieved in the process of in vitro fertilization (IVF)
Measured: immediately after the eggs retrieved
the number of available embryos
the number of available embryos in the process of IVF
Measured: 1 week after the eggs retrieved
the clinical pregnancy rate
the clinical pregnancy rate in the process of IVF
Measured: 4 weeks after the embryos transfer
the miscarriage rate
the miscarriage rate in the process of IVF
Measured: 7 months after embryos transfer
the live birth rate
the live birth rate in the process of IVF
Measured: 40 weeks after embryos transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2022
- Study start1 Jan 2018
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for IVFStudies of the same condition, open and under way.
- More trials run by Peking University People's 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
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shen Huan, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05373290
- Sponsor's protocol ID
- PKUPHIVF001
- Acronym
- PKU-ERC
- Status last verified
- May 2022
- First submitted
- 19 Apr 2022
- Last updated
- 13 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39892082
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adverse Effects and Mechanism of Environmental Endocrine Disrupting Chemicals on Female Reproductive health--the Peking University and Environment Reproductive Health Cohort
- ClinicalTrials.gov ID
- NCT05373290
- Acronym / sponsor ID
- PKU-ERC / PKUPHIVF001
- Conditions
- IVF
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 13 May 2022 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- All the couples intended to receive the treatment of IVF can be included in the study.
Key inclusion criteria (1 listed)
- Clinical diagnosis of infertile patients undergoing IVF treatment
Key exclusion criteria (1 listed)
- Donor egg transplants excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| there is no intervention in the studythere is no intervention in the study | Other | – |
Primary outcome
Number of eggs retrieved
Time frame: immediately after the eggs retrieved
the number of eggs retrieved in the process of in vitro fertilization (IVF)
the number of available embryos
Time frame: 1 week after the eggs retrieved
the number of available embryos in the process of IVF
the clinical pregnancy rate
Time frame: 4 weeks after the embryos transfer
the clinical pregnancy rate in the process of IVF
the miscarriage rate
Time frame: 7 months after embryos transfer
the miscarriage rate in the process of IVF
the live birth rate
Time frame: 40 weeks after embryos transfer
the live birth rate in the process of IVF
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2022.
- Derived from this study: PubMed 39892082Wang 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.
- Individual participant dataSharing planned: No
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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.
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 IVF, run by Peking University People's 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 1 inclusion and 1 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 13 May 2022. 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 Huan Shen, Doctor (86010-88324436, rmivf@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of eggs retrieved (time frame: immediately after the eggs retrieved). The study lists 5 primary outcomes in all. 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 NCT05373290, which also lists 1 linked publication.
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 13 May 2022.