ClinicalTrials.gg
Status unknownNCT04952012Updated Jul 7, 2021

The Effect of Thyroid Antibodies on Female Reproductive Function and Pregnancy Outcomes

An observational study in Thyroiditis, Autoimmune, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Status unknown at 1 site in China. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-07-07.

Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Observational

The sponsor has not verified this record recently (last verified Nov 2020), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
4,000
Ages
18 Years to 45 Years
Sex
Female
01

Study summary

Some women at reproductive age have positive antithyroid antibodies (ATAs). Thyroid peroxidase antibody (TPOAb) and thyroglobulin antibody (TgAb) are the most common ATAs. This study aimed to evaluate the impact of ATAs on maturation of women reproductive system and pregnancy outcomes.

02

Conditions studied

  • Thyroiditis, Autoimmune
03

In context

Thyroiditis, Autoimmune

27 studies on the registry are indexed under Thyroiditis, Autoimmune; 4 are open to participants now.

Browse Thyroiditis, Autoimmune studies →

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,047 studies on the registry; 502 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Subjects were all in the 1st trimester of pregnancy.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age during 18-45y;
  • Women tested for TPOAb and/or TgAb, TSH, free T3, free T4, total T3 and total T4 during the 1st trimester of pregnancy

Exclusion criteria

Exclusion Criteria:

  • Multiple pregnancies;
  • Age \< 18 y or > 40 y;
  • L-T4 or PTU intervention before pregnancy;
  • Other diseases.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

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Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
4,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • ATA-positive

    Drug: LT4

  • ATA-negative

    Drug: LT4

Interventions

  • DrugLT4

    LT4 is used to improve the thyroid function of pregnant women.

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What researchers measure

Primary outcomes

  1. Incidence rate of pregnancy complications in women with or without thyroid antibodies

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
  • Second Affiliated Hospital, School of Medicine, Zhejiang University
    Hangzhou, Zhejiang 310009, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 7, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04952012
Collaborators
First People's Hospital of Yuhang, Taizhou Women and Children's Hospital Affiliated to Wenzhou Medical University, Changxing People's Hospital
Responsible party
Sponsor
First posted
Jul 7, 2021
Start date
Nov 30, 2020
Primary completion
Nov 30, 2021 (estimated)
Completion
Nov 30, 2022 (estimated)
Last update
Jul 7, 2021

Study contacts

Min Jin
Contact
min_jin@zju.edu.cn
057187783759

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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