Impact of Thyroid Treatment on Ovarian Function and Pregnancy Outcomes in Women with Differentiated Thyroid Cancer

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-20

Study Completion Date

2028-12-31

Brief Summary

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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.

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Detailed Description

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1\) Screen the patients in the group according to the inclusion and exclusion criteria and sign the informed consent form (a total of 300 patients were included). Fill in the questionnaire after joining the group. 2) Physical examination of patients before treatment (measure height, weight, waist circumference, hip circumference, body fat distribution and percentage); thyroid function test (thyroid B-ultrasound, TSH, FT3, FT4, TPO-Ab, TG-Ab); baseline ovarian function test (AMH, menstruation 1-3 days Six hormones, observe the ovarian condition and the number of sinus follicles through vaginal B-ultrasound); leave blood for scientific research: 2 tubes of coagulation (serum), 1 tube of whole blood, -80℃ freeze. 3) Different types of thyroid surgery (thyroid unilateral lobe + isthmus resection, total thyroidectomy, total thyroidectomy + RAIT) are treated. 4) 3, 6, 12 and 24 months after treatment, the patients in the group should be followed up on ovarian and thyroid function, including physical examination (measurement of height, weight, waist circumference, hip circumference, body fat distribution and percentage); thyroid function testing (thyroid B-ultrasound, TSH, FT3, FT4, TPO-Ab, T G-Ab); ovarian function test (AMH, six items of sex hormones for 1-3 days of menstruation, observation of ovarian conditions and the number of sinus follicles through vaginal B-ultrasound); retention of blood for scientific research: 2 tubes (serum) of blood-promoting blood, 1 tube of whole blood, -80℃ freezing; record adverse reactions and combined medication. 5) If the patient in the group is pregnant during the follow-up period, the pregnancy follow-up shall be carried out according to the CRF table items at 2, 4, 12, 28 and 37 weeks of pregnancy respectively; delivery follow-up shall be carried out on the day of delivery and 6 weeks after delivery. 6) After the research, collect and sort out data for statistical analysis, summarize and sort out the results and publish them in professional journals in relevant fields in the form of papers.

Conditions

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Thyroid Gland

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Thyroid one-sided lobe + isthmus resection

Group Type EXPERIMENTAL

Thyroid one-sided lobe + isthmus resection

Intervention Type PROCEDURE

Thyroid one-sided lobe + isthmus resection

Total thyroidectomy

Group Type EXPERIMENTAL

Total thyroidectomy

Intervention Type PROCEDURE

Total thyroidectomy

Total thyroidectomy + RAIT

Group Type EXPERIMENTAL

Total thyroidectomy + RAIT

Intervention Type PROCEDURE

Total thyroidectomy + RAIT

Interventions

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Total thyroidectomy

Intervention Type PROCEDURE

Total thyroidectomy + RAIT

Intervention Type PROCEDURE

Thyroid one-sided lobe + isthmus resection

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Age 20-45 years old;
2. Premenopausal women whose thyroid B-ultrasound + surgical pathology is clearly differentiated thyroid cancer (papillar thyroid cancer or follicular thyroid cancer);
3. TNM stage is in stage I (T1-3, N0 or N1, M0);
4. Treatment of thyroid tumor resection: unilateral lobe of the thyroid + isthmus resection, total thyroidectomy, total thyroidectomy + RAIT.

Exclusion Criteria

1. Patients with malignant tumors in other parts or low undifferentiated thyroid cancer;
2. Patients with abnormal liver and kidney function;
3. TNM stage II and above;
4. History of ovarian surgery, hysterectomy, pelvic surgery or radiation therapy;
5. Pregnancy;
6. 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.
7. Patients diagnosed with polycystic ovary syndrome by the Rotterdam standard;
8. Patients with ovarian failure;
9. Patients have infectious factors, immune diseases and metabolic diseases that may affect pregnancy outcomes;
10. Pregnancy contraindications or diseases that have a clear impact on pregnancy.

Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No