Fertility DisordersNCT05164029
The Clinical Cohort Study of Reproductive Health
An observational study of Fertility Disorders and Assisted Reproductive Technology, run by Women's Hospital School Of Medicine Zhejiang University.
Trial summary
The study will conduct a multicenter prospective clinical cohort study to collect comprehensive health information and essential specimens from pre-pregnancy to postpartum offspring development. Read more about this study
- Who is it for?
- Ages 20 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Fertility Disorders, Assisted Reproductive Technology, Offspring Health
- What is being tested?
- Completion questionnaires/providing biological samples
- How many people
- 3,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2022to 1 Dec 2024
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Study subjects will be recruited from couples seeking treatment of infertility or getting pregnant naturally and wanting to deliver their babies in the study hospitals. Men must be at least 22 years old and women must be at least 20 years to participate in the study.
Who may be able to join
- Couples undergoing treatment for infertility or getting pregnant naturally and wanting to deliver their babies in study hospitals.
- Men 22-55 years old
- Women 20 - 45 years old
Who cannot join
- Any individual or couple who is outside of age range .
- Any couple who don't plan to complete their pregnancy check-up or deliver their babies in study hospitals.
- Any couples had participated in other clinical studies.
Trial locations and contacts
No sites are listed yet.
About this study
The study will conduct a multicenter prospective clinical cohort study to collect comprehensive health information and essential specimens from pre-pregnancy to postpartum offspring development. We will combine the reproductive medicine with the big data technologies and cloud computing to explore the key factors which will induce the occurrence the reproductive disorders and effect the health of women and offspring. Based on the discovery of the cohort study, we will construct a prediction model for improvement of ART，optimizing the effectiveness and safety of ART.
Read the detailed description
Safeguarding the health of women and children is an important part of The Healthy China 2030 Plan. Precisely controlling the fertility process will help to improve the quality of national population. Lots of studies have reported that environmental exposure, lifestyle, diet and other factors are related to fertility, female pregnancy and postpartum health, and offspring development. Some studies have found that assisted reproductive technology (ART) represents an increased risk of epigenetic-related diseases or birth defects.
The study will conduct a multicenter prospective clinical cohort study to collect comprehensive health information and essential specimens from pre-pregnancy to postpartum offspring development. We will combine the reproductive medicine with the big data technologies and cloud computing to explore the key factors which will induce the occurrence the reproductive disorders and effect the health of women and offspring. Based on the discovery of the cohort study, we will construct a prediction model for improvement of ART，optimizing the effectiveness and safety of ART.
- Being tested
- Completion questionnaires/providing biological samples
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Completion questionnaires/providing biological samplesOther
Participant completes baseline interview at enrollment, then completes questionnaires and provides biological samples at each scheduled study visit.
| Study group | Role | What they receive |
|---|---|---|
| ART couples | Couples in reproductive age undergoing ART treatment Receives: Other: Completion questionnaires/providing biological samples | |
| natural pregnancy couples | Couples who get pregnant naturally Receives: Other: Completion questionnaires/providing biological samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
live birth rate
Number of women with live births / number of women randomized to the specific group.
Measured: 1 day after delivery
birth weight
Weight of newborns at delivery.
Measured: 1 day after delivery
weight
the weight of offspring
Measured: Change from the date of delivery up to 2 years after delivery
height
the height of offspring
Measured: Change from the date of delivery up to 2 years after delivery
Incidence of mental diseases and metabolic dysfunction
Measured: from the date of delivery up to 2 years after delivery
Secondary outcomes (4)
implantation rate
Implantation rate was defined as the percentage of fetal heart beat among total transferred embryos at 12 weeks' gestational age.
Measured: 11-12 weeks after embryo transfer
clinical pregnancy rate
Clinical pregnancy was defined as an observation of gestational sac via ultrasonography.
Measured: 6 weeks after embryo transfer
preterm birth rate
preterm birth is defined as gestational weeks between 28 to 37.
Measured: 28 gestational weeks to 37 gestational weeks
neonatal complication rate
Neonatal complication includes neonatal respiratory disorders, neonatal cerebral palsy, neonatal encephalopathy and other disease that should been sent into neonatal ICU.
Measured: 1 day after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2021
- Study start1 Jan 2022 (estimated)
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fertility DisordersStudies of the same condition, open and under way.
- 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
- 3,000 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Women's Hospital School Of Medicine Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dan Zhang, Women's Hospital School Of Medicine Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05164029
- Sponsor's protocol ID
- CSRH
- Status last verified
- Dec 2021
- First submitted
- 9 Dec 2021
- Last updated
- 20 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All data relevant to the study will be generated in the article or uploaded as supplementary information. Deidentified participant data will be available from Dr. Dan Zhang (zhangdan@zju.edu.cn) on a reasonable request. Protocols and statistical analysis plans will be included as supplementary information.
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Cohort Study of Reproductive Health
- ClinicalTrials.gov ID
- NCT05164029
- Acronym / sponsor ID
- CSRH
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Women's Hospital School Of Medicine Zhejiang UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (estimated)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 20 Dec 2021 (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 will conduct a multicenter prospective clinical cohort study to collect comprehensive health information and essential specimens from pre-pregnancy to postpartum offspring development. We will combine the reproductive medicine with the big data technologies and cloud computing to explore the key factors which will induce the occurrence the reproductive disorders and effect the health of women and offspring. Based on the discovery of the cohort study, we will construct a prediction model for improvement of ART，optimizing the effectiveness and safety of ART.
Detailed description
Safeguarding the health of women and children is an important part of The Healthy China 2030 Plan. Precisely controlling the fertility process will help to improve the quality of national population. Lots of studies have reported that environmental exposure, lifestyle, diet and other factors are related to fertility, female pregnancy and postpartum health, and offspring development. Some studies have found that assisted reproductive technology (ART) represents an increased risk of epigenetic-related diseases or birth defects.
The study will conduct a multicenter prospective clinical cohort study to collect comprehensive health information and essential specimens from pre-pregnancy to postpartum offspring development. We will combine the reproductive medicine with the big data technologies and cloud computing to explore the key factors which will induce the occurrence the reproductive disorders and effect the health of women and offspring. Based on the discovery of the cohort study, we will construct a prediction model for improvement of ART，optimizing the effectiveness and safety of ART.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ART couples | – | Other: Completion questionnaires/providing biological samplesCouples in reproductive age undergoing ART treatment |
| natural pregnancy couples | – | Other: Completion questionnaires/providing biological samplesCouples who get pregnant naturally |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Study subjects will be recruited from couples seeking treatment of infertility or getting pregnant naturally and wanting to deliver their babies in the study hospitals. Men must be at least 22 years old and women must be at least 20 years to participate in the study.
Key inclusion criteria (3 listed)
- Couples undergoing treatment for infertility or getting pregnant naturally and wanting to deliver their babies in study hospitals.
- Men 22-55 years old
- Women 20 - 45 years old
Key exclusion criteria (3 listed)
- Any individual or couple who is outside of age range .
- Any couple who don't plan to complete their pregnancy check-up or deliver their babies in study hospitals.
- Any couples had participated in other clinical studies.
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 |
|---|---|---|
| Completion questionnaires/providing biological samplesParticipant completes baseline interview at enrollment, then completes questionnaires and provides biological samples at each scheduled study visit. | Other | ART couples, natural pregnancy couples |
Primary outcome
live birth rate
Time frame: 1 day after delivery
Number of women with live births / number of women randomized to the specific group.
birth weight
Time frame: 1 day after delivery
Weight of newborns at delivery.
weight
Time frame: Change from the date of delivery up to 2 years after delivery
the weight of offspring
height
Time frame: Change from the date of delivery up to 2 years after delivery
the height of offspring
Incidence of mental diseases and metabolic dysfunction
Time frame: from the date of delivery up to 2 years after delivery
4 secondary outcomes
implantation rate
Time frame: 11-12 weeks after embryo transfer
clinical pregnancy rate
Time frame: 6 weeks after embryo transfer
preterm birth rate
Time frame: 28 gestational weeks to 37 gestational weeks
neonatal complication rate
Time frame: 1 day after delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2021.
- Individual participant dataSharing planned: No. All data relevant to the study will be generated in the article or uploaded as supplementary information. Deidentified participant data will be available from Dr. Dan Zhang (zhangdan@zju.edu.cn) on a reasonable request. Protocols and statistical analysis plans will be included as supplementary information.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Fertility Disorders and Assisted Reproductive Technology, run by Women's Hospital School Of Medicine Zhejiang University.
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 3 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 20 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
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 Dan Zhang, M.D, Ph.D (13735808888, zhangdan@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
live birth rate (time frame: 1 day after delivery). 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?
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 20 Dec 2021.