NCT06426732

Brief Summary

The incidence of gestational hypertension and preeclampsia in the assisted reproductive technology population during pregnancy was significantly higher than that in the general normal pregnancy population. The use of assisted reproductive technology in this population due to infertility is often accompanied by many hypertension-related factors. We established a prospective cohort study based on assisted reproductive technology pregnancy population and natural pregnancy population. Through continuous monitoring of blood pressure changes and other risk factors during pregnancy in the two groups, we explored the trajectory trend and inflection point of assisted reproductive technology pregnancy population blood pressure during pregnancy. Through factor analysis, the risk factors of elevated blood pressure during pregnancy can be clearly identified, so as to carry out early intervention and strengthen the control of risk factors of elevated blood pressure in assisted reproductive technology population, in order to expect benign maternal and infant outcomes.

Trial Health

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Trial Health Score

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Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2022

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

May 18, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 23, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

May 23, 2024

Status Verified

May 1, 2024

Enrollment Period

2.2 years

First QC Date

May 18, 2024

Last Update Submit

May 18, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • The Trajectory of Blood Pressure During Pregnancy in Assisted Reproductive Females

    The Trajectory of Blood Pressure During Pregnancy in Assisted Reproductive Females

    from pregnancy to delivery

Study Arms (2)

Natural pregnancy group

Assisted Reproductive Technology Group

Eligibility Criteria

Age20 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

collect sixty patients in each group

You may qualify if:

  • Exposure group:
  • Mother: Seen in the obstetrics department of our hospital and meet the following conditions at the same time:
  • Complete at least one cycle of IVF or ICSI, PGD or IVM treatment (including natural cycles);
  • Clinical pregnancy was obtained after treatment. Offspring: Offspring born after in vitro fertilization-embryo transfer technique.
  • Non-exposed group:
  • Mother: A mother who conceived naturally. Offspring: 1) Offspring born by natural pregnancy. 2) Offspring born from natural pregnancy of exposed mothers.

You may not qualify if:

  • Unwilling to participate in this research;
  • Unable to participate in this study due to special reasons, such as death, immigration, loss to follow-up;
  • Hereditary diseases, mental diseases, malignant tumors, pre-pregnancy hypertension, uterine malformations and other reproductive organ malformations;
  • Pregnant women who voluntarily terminate pregnancy due to non-preeclampsia factors;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cui linlin

Jinan, China

RECRUITING

Central Study Contacts

Wenting Wang, M.D. Ph.D.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 18, 2024

First Posted

May 23, 2024

Study Start

November 1, 2022

Primary Completion

December 31, 2024

Study Completion

June 30, 2025

Last Updated

May 23, 2024

Record last verified: 2024-05

Locations