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Epigenetic Safety of Assisted Reproductive Technology

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04065945
Recruitment Status : Not yet recruiting
First Posted : August 22, 2019
Last Update Posted : August 22, 2019
Sponsor:
Collaborators:
International Peace Maternity and Child Health Hospital
Changhai Hospital
Information provided by (Responsible Party):
Dan Zhang, Women's Hospital School Of Medicine Zhejiang University

Brief 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 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.

Condition or disease Intervention/treatment
Infertility Other: Completion questionnaires/providing biological samples

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Study Type : Observational
Estimated Enrollment : 15000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Epigenetic Safety of Various Protocols in Assisted Reproductive Technology
Estimated Study Start Date : September 15, 2019
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2024

Group/Cohort Intervention/treatment
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.
Other: Completion questionnaires/providing biological samples
Participant completes baseline interview at enrollment, then completes questionnaires and provides biological samples at each scheduled study visit.

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.
Other: Completion questionnaires/providing biological samples
Participant completes baseline interview at enrollment, then completes questionnaires and provides biological samples at each scheduled study visit.




Primary Outcome Measures :
  1. 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.

  2. birth weight [ Time Frame: 1 day after delivery ]
    Weight of newborns at delivery.

  3. 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.

  4. clinical pregnancy rate [ Time Frame: 6 weeks after embryo transfer ]
    Clinical pregnancy was defined as an observation of gestational sac via ultrasonography.

  5. congenital anomalies rate [ Time Frame: 1 day after delivery ]
    Congenital anomaly included deformity and development abnormality of any organs or systems.

  6. weight [ Time Frame: Change from the date of delivery up to 4 years after delivery ]
    the weight of offspring

  7. height [ Time Frame: Change from the date of delivery up to 4 years after delivery ]
    the height of offspring

  8. Incidence of mental diseases and metabolic dysfunction [ Time Frame: 4 years after delivery ]

Secondary Outcome Measures :
  1. biochemical pregnancy rate [ Time Frame: 2 weeks after embryo transfer ]
    Biochemical pregnancy is defined as numbers of women with an elevated serum β-hCG level of more than 10 mIU/ml.

  2. pregnancy loss rate [ Time Frame: 28 gestational weeks in maximum ]
    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.

  3. ectopic pregnancy rate [ Time Frame: 12 gestational weeks in maximum ]
    Ectopic pregnancy is defined as an embryo implanted outside the uterine.

  4. preterm birth rate [ Time Frame: 28 gestational weeks to 37 gestational weeks ]
    preterm birth is defined as gestational weeks between 28 to 37.

  5. Incidence of moderate to severe ovarian hyperstimulation syndrome(OHSS) [ Time Frame: 3 months after controlled ovarian hyperstimulation ]
    Number of cycles of moderate to severe OHSS/total number of fresh stimulation cycle.

  6. neonatal complication rate [ Time Frame: 1 day after delivery ]
    Neonatal complication includes neonatal respiratory disorders, neonatal cerebral palsy, neonatal encephalopathy and other disease that should been sent into neonatal ICU.


Biospecimen Retention:   Samples With DNA
Whole blood, urine, granulosa cells, follicular fluid , sperm and semen ,abandoned egg or embryo,villi, decidua, placenta, amniotic fluid, umbilical cord blood, and buccal swabs of the offspring.


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  1. 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.
  2. Men 22-55 years old
  3. Women 20 - 45 years old

Exclusion Criteria:

  1. Any individual or couple who is outside of age range .
  2. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04065945


Contacts
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Contact: Dan Zhang, M.D, Ph.D 86-571-87061501-1008 zhangdan@zju.edu.cn

Locations
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China, Zhejiang
Women's Hospital School of Medicine Zhejiang University
Hangzhou, Zhejiang, China
Contact: Dan Zhang, M.D., Ph.D    86-571-87061501-1008    zhangdan@zju.edu.cn   
Sponsors and Collaborators
Women's Hospital School Of Medicine Zhejiang University
International Peace Maternity and Child Health Hospital
Changhai Hospital
Investigators
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Principal Investigator: Dan Zhang, M.D, Ph.D Women's Hospital School Of Medicine Zhejiang University
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Responsible Party: Dan Zhang, Principal Investigator, Women's Hospital School Of Medicine Zhejiang University
ClinicalTrials.gov Identifier: NCT04065945    
Other Study ID Numbers: 2018YFC1005003
First Posted: August 22, 2019    Key Record Dates
Last Update Posted: August 22, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infertility
Genital Diseases, Male
Genital Diseases, Female