InfertilityNCT04065945
Epigenetic Safety of Assisted Reproductive Technology
An observational study of Infertility, run by Women's Hospital School Of Medicine Zhejiang University at 1 site in China.
Trial summary
The primary purpose of the study is to investigate the relationship between different protocols of assisted reproductive technology and the epigenetic safety of the offspring. Different interventions of assisted reproductive technology include controlled ovarian hyperstimulation (COH), in vitro embryo culture, in… Read more about this study
- Who is it for?
- Ages 20 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- Completion questionnaires/providing biological samples
- How many people
- 15,000 participants
- Where
- 1 siteChina
- Study dates
- 15 Sep 2019to 31 Dec 2024
- 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 at the Women's Hospital School of Medicine Zhejiang University. 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 Women's Hospital School of Medicine Zhejiang University, The International Peace Maternity \& Child Health Hospital, and Changhai Hospital of Shanghai.
- 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 Women's Hospital School of Medicine Zhejiang University, The International Peace Maternity \& Child Health Hospital, or Changhai Hospital of Shanghai.
Trial locations and contacts
1 site in 1 country.
China1 site
Women's Hospital School of Medicine Zhejiang University
Hangzhou, Zhejiang
Dan Zhang, M.D., Ph.D, 86-571-87061501-1008, zhangdan@zju.edu.cn
About this study
Official title: Epigenetic Safety of Various Protocols in Assisted Reproductive Technology
The primary purpose of the study is to investigate the relationship between different protocols of assisted reproductive technology and the epigenetic safety of the offspring. Different interventions of assisted reproductive technology include controlled ovarian hyperstimulation (COH), in vitro embryo culture, in vitro fertilization(IVF), intracytoplasmic sperm injection(ICSI), frozen-thawed embryo transfer(FET), preimplantation genetic testing(PGT). The investigators are also interested in the relationship between pregnancy outcomes in ART or natural conception and environmental, nutritional and lifestyle factors.
- Conditions
- Infertility
- Being tested
- Completion questionnaires/providing biological samples
- Medical subject headings
- Infertility
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 |
|---|---|---|
| Couples undergoing ART treatment | Couples in reproductive age undergoing ART treatment in Women's Hospital School of Medicine Zhejiang University, The International Peace Maternity \& Child Health Hospital, and Changhai Hospital of Shanghai. Receives: Other: Completion questionnaires/providing biological samples | |
| Couples getting pregnant naturally | Couples who get pregnant naturally and want to deliver the babies in Women's Hospital School of Medicine Zhejiang University, The International Peace Maternity \& Child Health Hospital, and Changhai Hospital of Shanghai. 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.Live birth is defined as the delivery of any viable infant at 28 weeks or more of gestation after our interventions.
Measured: 1 day after delivery
birth weight
Weight of newborns at delivery.
Measured: 1 day after delivery
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
congenital anomalies rate
Congenital anomaly included deformity and development abnormality of any organs or systems.
Measured: 1 day after delivery
weight
the weight of offspring
Measured: Change from the date of delivery up to 4 years after delivery
height
the height of offspring
Measured: Change from the date of delivery up to 4 years after delivery
Incidence of mental diseases and metabolic dysfunction
Measured: 4 years after delivery
Secondary outcomes (6)
biochemical pregnancy rate
Biochemical pregnancy is defined as numbers of women with an elevated serum β-hCG level of more than 10 mIU/ml.
Measured: 2 weeks after embryo transfer
pregnancy loss rate
Pregnancy loss is defined as any reason that resulted in failure of an embryo to develop, embryonic or fetal death, or spontaneous expulsion of a pregnancy.
Measured: 28 gestational weeks in maximum
ectopic pregnancy rate
Ectopic pregnancy is defined as an embryo implanted outside the uterine.
Measured: 12 gestational weeks in maximum
preterm birth rate
preterm birth is defined as gestational weeks between 28 to 37.
Measured: 28 gestational weeks to 37 gestational weeks
Incidence of moderate to severe ovarian hyperstimulation syndrome(OHSS)
Number of cycles of moderate to severe OHSS/total number of fresh stimulation cycle.
Measured: 3 months after controlled ovarian hyperstimulation
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 posted22 Aug 2019
- Study start15 Sep 2019 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies 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
- 15,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Women's Hospital School Of Medicine Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- International Peace Maternity and Child Health Hospital, Changhai Hospital
- Responsible party
- Principal investigator, Dan Zhang, Women's Hospital School Of Medicine Zhejiang University
- Investigators
- Dan Zhang, M.D, Ph.D, Principal investigator, Women's Hospital School Of Medicine Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04065945
- Sponsor's protocol ID
- 2018YFC1005003
- Status last verified
- Aug 2019
- First submitted
- 12 Aug 2019
- Last updated
- 22 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epigenetic Safety of Various Protocols in Assisted Reproductive Technology
- ClinicalTrials.gov ID
- NCT04065945
- Acronym / sponsor ID
- 2018YFC1005003
- Conditions
- Infertility
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15,000 participants (estimated)
- Lead sponsor
- Women's Hospital School Of Medicine Zhejiang UniversityUniversity, hospital or other
- Collaborators
- International Peace Maternity and Child Health Hospital, Changhai Hospital
- Study start
- 15 Sep 2019 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 22 Aug 2019 (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 primary purpose of the study is to investigate the relationship between different protocols of assisted reproductive technology and the epigenetic safety of the offspring. Different interventions of assisted reproductive technology include controlled ovarian hyperstimulation (COH), in vitro embryo culture, in vitro fertilization(IVF), intracytoplasmic sperm injection(ICSI), frozen-thawed embryo transfer(FET), preimplantation genetic testing(PGT). The investigators are also interested in the relationship between pregnancy outcomes in ART or natural conception and environmental, nutritional and lifestyle factors.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Couples undergoing ART treatment | – | Other: Completion questionnaires/providing biological samplesCouples in reproductive age undergoing ART treatment in Women's Hospital School of Medicine Zhejiang University, The International Peace Maternity \& Child Health Hospital, and Changhai Hospital of Shanghai. |
| Couples getting pregnant naturally | – | Other: Completion questionnaires/providing biological samplesCouples who get pregnant naturally and want to deliver the babies in Women's Hospital School of Medicine Zhejiang University, The International Peace Maternity \& Child Health Hospital, and Changhai Hospital of Shanghai. |
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 at the Women's Hospital School of Medicine Zhejiang University. 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 Women's Hospital School of Medicine Zhejiang University, The International Peace Maternity \& Child Health Hospital, and Changhai Hospital of Shanghai.
- Men 22-55 years old
- Women 20 - 45 years old
Key exclusion criteria (2 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 Women's Hospital School of Medicine Zhejiang University, The International Peace Maternity \& Child Health Hospital, or Changhai Hospital of Shanghai.
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 | Couples getting pregnant naturally, Couples undergoing ART treatment |
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.Live birth is defined as the delivery of any viable infant at 28 weeks or more of gestation after our interventions.
birth weight
Time frame: 1 day after delivery
Weight of newborns at delivery.
implantation rate
Time frame: 11-12 weeks after embryo transfer
Implantation rate was defined as the percentage of fetal heart beat among total transferred embryos at 12 weeks' gestational age.
clinical pregnancy rate
Time frame: 6 weeks after embryo transfer
Clinical pregnancy was defined as an observation of gestational sac via ultrasonography.
congenital anomalies rate
Time frame: 1 day after delivery
Congenital anomaly included deformity and development abnormality of any organs or systems.
weight
Time frame: Change from the date of delivery up to 4 years after delivery
the weight of offspring
height
Time frame: Change from the date of delivery up to 4 years after delivery
the height of offspring
Incidence of mental diseases and metabolic dysfunction
Time frame: 4 years after delivery
6 secondary outcomes
biochemical pregnancy rate
Time frame: 2 weeks after embryo transfer
pregnancy loss rate
Time frame: 28 gestational weeks in maximum
ectopic pregnancy rate
Time frame: 12 gestational weeks in maximum
preterm birth rate
Time frame: 28 gestational weeks to 37 gestational weeks
Incidence of moderate to severe ovarian hyperstimulation syndrome(OHSS)
Time frame: 3 months after controlled ovarian hyperstimulation
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 22 Aug 2019.
- Individual participant dataSharing planned: Undecided
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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.
Dan Zhang, M.D, Ph.D principal investigator
Women's Hospital School Of Medicine Zhejiang University
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 Infertility, run by Women's Hospital School Of Medicine Zhejiang University 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 3 inclusion and 2 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 22 Aug 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 Dan Zhang, M.D, Ph.D (86-571-87061501-1008, 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 8 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 22 Aug 2019.