Epigenetic Safety of Assisted Reproductive Technology

NCT ID: NCT04065945

Last Updated: 2019-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

15000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-15

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Infertility

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Completion questionnaires/providing biological samples

Intervention Type OTHER

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.

Completion questionnaires/providing biological samples

Intervention Type OTHER

Participant completes baseline interview at enrollment, then completes questionnaires and provides biological samples at each scheduled study visit.

Interventions

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Completion questionnaires/providing biological samples

Participant completes baseline interview at enrollment, then completes questionnaires and provides biological samples at each scheduled study visit.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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International Peace Maternity and Child Health Hospital

OTHER

Sponsor Role collaborator

Changhai Hospital

OTHER

Sponsor Role collaborator

Women's Hospital School Of Medicine Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Dan Zhang

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dan Zhang, M.D, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Women's Hospital School Of Medicine Zhejiang University

Locations

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Women's Hospital School of Medicine Zhejiang University

Hangzhou, Zhejiang, China

Site Status

Countries

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China

Central Contacts

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Dan Zhang, M.D, Ph.D

Role: CONTACT

86-571-87061501-1008

Facility Contacts

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Dan Zhang, M.D., Ph.D

Role: primary

86-571-87061501-1008

Other Identifiers

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2018YFC1005003

Identifier Type: -

Identifier Source: org_study_id

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