Clinical trial NCT06845098: Impact of Thyroid Treatment on Ovarian Function and Pregnancy Outcomes in Women with Differentiated Thyroid Cancer
Official title: Impact of Thyroid Treatment on Ovarian Function and Pregnancy Outcomes in Women with Differentiated Thyroid Cancer: a Prospective Cohort Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Thyroid Gland
Lead sponsor: Zhejiang Provincial People's Hospital
Sponsor class: OTHER
First posted: 2025-02-25
Enrollment: 300
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: AMH level
timeFrame: before treatment and 3, 6, 12 and 24 months after treatment
Secondary outcomes:
measure: Thyroid function
timeFrame: before tratment and 3, 6, 12 and 24 months after treatment
measure: clinical pregnancy rate
timeFrame: up to 24 months after the treatment
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital
state: Zhejiang
Study officials:
affiliation: Zhejiang Provincial People's Hospital
name: Minghua Ge
role: STUDY_CHAIR
References: