NCT06845098

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

Impact of Thyroid Treatment on Ovarian Function and Pregnancy Outcomes in Women with Differentiated Thyroid Cancer: a Prospective Cohort Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Zhejiang Provincial People's Hospital · Academic / Other
• Sex: Female
• Age: 20 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Thyroid Gland

Interventions

Type	Name	Description
PROCEDURE	Total thyroidectomy	Total thyroidectomy
PROCEDURE	Total thyroidectomy + RAIT	Total thyroidectomy + RAIT
PROCEDURE	Thyroid one-sided lobe + isthmus resection	Thyroid one-sided lobe + isthmus resection

Timeline

• Start date: 2025-02-20
• Primary completion: 2027-12-31
• Completion: 2028-12-31
• First posted: 2025-02-25
• Last updated: 2025-02-25

Locations

1 site across 1 country: China