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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Thyroid Gland
• Intervention / Treatment: Procedure: Total thyroidectomy; Procedure: Thyroid one-sided lobe + isthmus resection; Procedure: Total thyroidectomy + RAIT

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.

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Minghua Ge; Phone Number: 86+15673187412; Email: tingtingzhou2019@163.com

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Zhejiang Provincial People's Hospital
      • Contact: Minghua Ge; Phone Number: 86+0571-87666666; Email: zjsrmyy@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Thyroid one-sided lobe + isthmus resection	Procedure: Thyroid one-sided lobe + isthmus resection; Thyroid one-sided lobe + isthmus resection
Experimental: Total thyroidectomy	Procedure: Total thyroidectomy; Total thyroidectomy
Experimental: Total thyroidectomy + RAIT	Procedure: Total thyroidectomy + RAIT; Total thyroidectomy + RAIT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AMH level	Measure the concentration of AMH in serum	before treatment and 3, 6, 12 and 24 months after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Thyroid function	Measure the level of TSH、T3、T4、FT3、FT4、TGAB、TPOAB in serum	before tratment and 3, 6, 12 and 24 months after treatment
clinical pregnancy rate	Clinical pregnancy is defined as the detection of intrauterine gestational sac through ultrasound, and the clinical pregnancy rate is calculated by clinically pregnant women/total women.	up to 24 months after the treatment

Collaborators and Investigators

• Sponsor: Zhejiang Provincial People's Hospital
• Investigators: Study Chair: Minghua Ge, Zhejiang Provincial People's Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): February 20, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: February 10, 2025
• First Submitted That Met QC Criteria: February 19, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 19, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Thyroid Diseases; Thyroid Neoplasms
• Other Study ID Numbers: KY2024117-Ge

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No