Impact of Thyroid Treatment on Ovarian Function and Pregnancy Outcomes in Women with Differentiated Thyroid Cancer
1 other identifier
interventional
300
1 country
1
Brief Summary
This project aims to study the effects of different types of thyroid surgery and RAIT on ovarian function and pregnancy outcomes of DTC women of childbearing age, analyze possible risk factors, and assess whether potential risk factors such as age, thyroid stimulating hormone (TSH) levels and positive thyroid antibodies are related to ovarian hypofunction and adverse pregnancy outcomes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2025
Longer than P75 for not_applicable
1 active site
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
First Submitted
Initial submission to the registry
February 10, 2025
CompletedStudy Start
First participant enrolled
February 20, 2025
CompletedFirst Posted
Study publicly available on registry
February 25, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
February 25, 2025
February 1, 2025
2.9 years
February 10, 2025
February 19, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
AMH level
Measure the concentration of AMH in serum
before treatment and 3, 6, 12 and 24 months after treatment
Secondary Outcomes (2)
Thyroid function
before tratment and 3, 6, 12 and 24 months after treatment
clinical pregnancy rate
up to 24 months after the treatment
Study Arms (3)
Thyroid one-sided lobe + isthmus resection
EXPERIMENTALThyroid one-sided lobe + isthmus resection
Total thyroidectomy
EXPERIMENTALTotal thyroidectomy
Total thyroidectomy + RAIT
EXPERIMENTALTotal thyroidectomy + RAIT
Interventions
Thyroid one-sided lobe + isthmus resection
Eligibility Criteria
You may qualify if:
- Age 20-45 years old;
- Premenopausal women whose thyroid B-ultrasound + surgical pathology is clearly differentiated thyroid cancer (papillar thyroid cancer or follicular thyroid cancer);
- TNM stage is in stage I (T1-3, N0 or N1, M0);
- Treatment of thyroid tumor resection: unilateral lobe of the thyroid + isthmus resection, total thyroidectomy, total thyroidectomy + RAIT.
You may not qualify if:
- Patients with malignant tumors in other parts or low undifferentiated thyroid cancer;
- Patients with abnormal liver and kidney function;
- TNM stage II and above;
- History of ovarian surgery, hysterectomy, pelvic surgery or radiation therapy;
- Pregnancy;
- Have the following uterine abnormalities, such as uterine malformation (single-horned uterus, double uterus); untreated mediastinal uterus, submucosal uterine fibroids, multiple endometrial polyps, or severe uterine adhesion.
- Patients diagnosed with polycystic ovary syndrome by the Rotterdam standard;
- Patients with ovarian failure;
- Patients have infectious factors, immune diseases and metabolic diseases that may affect pregnancy outcomes;
- Pregnancy contraindications or diseases that have a clear impact on pregnancy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, 310000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Minghua Ge
Zhejiang Provincial People's Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 10, 2025
First Posted
February 25, 2025
Study Start
February 20, 2025
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2028
Last Updated
February 25, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will not share