Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06845098

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

20 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, 310000, China

Location contact

Minghua Ge

CONTACT

[email protected]

86+0571-87666666

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Total thyroidectomy

Procedure

Total thyroidectomy

Total thyroidectomy + RAIT

Procedure

Total thyroidectomy + RAIT

Thyroid one-sided lobe + isthmus resection

Procedure

Thyroid one-sided lobe + isthmus resection

Primary outcomes

  1. AMH level

    Time frame: before treatment and 3, 6, 12 and 24 months after treatment

    Measure the concentration of AMH in serum

Secondary outcomes

  1. Thyroid function

    Time frame: before tratment and 3, 6, 12 and 24 months after treatment

    Measure the level of TSH、T3、T4、FT3、FT4、TGAB、TPOAB in serum

  2. clinical pregnancy rate

    Time frame: up to 24 months after the treatment

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Minghua Ge

CONTACT

[email protected]

86+15673187412

Sponsors and collaborators

Lead sponsor

Zhejiang Provincial People's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Feb 25, 2025
Registry last updated
Feb 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.