Thyroid GlandNCT06845098
Impact of Thyroid Treatment on Ovarian Function and Pregnancy Outcomes in Women with Differentiated Thyroid Cancer
A study testing Total thyroidectomy, Total thyroidectomy + RAIT and Thyroid one-sided lobe + isthmus resection in people with Thyroid Gland, run by Zhejiang Provincial People's Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Thyroid Gland
- What is being tested?
- Total thyroidectomy, Total thyroidectomy + RAIT and Thyroid one-sided lobe + isthmus resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 20 Feb 2025to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, 310000
Minghua Ge, 86+0571-87666666, zjsrmyy@hotmail.com
About this study
Official title: 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.
Read the detailed description
- 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
- Being tested
- Total thyroidectomy, Total thyroidectomy + RAIT, Thyroid one-sided lobe + isthmus resection
- Medical subject headings
- Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total thyroidectomyProcedure or surgery
Total thyroidectomy
Total thyroidectomy + RAITProcedure or surgery
Total thyroidectomy + RAIT
Thyroid one-sided lobe + isthmus resectionProcedure or surgery
Thyroid one-sided lobe + isthmus resection
| Study group | Role | What they receive |
|---|---|---|
| Thyroid one-sided lobe + isthmus resection | Experimental | Thyroid one-sided lobe + isthmus resection Receives: Procedure: Thyroid one-sided lobe + isthmus resection |
| Total thyroidectomy | Experimental | Total thyroidectomy Receives: Procedure: Total thyroidectomy |
| Total thyroidectomy + RAIT | Experimental | Total thyroidectomy + RAIT Receives: Procedure: Total thyroidectomy + RAIT |
What is being measured
The primary outcome is the main question the study is designed to answer.
AMH level
Measure the concentration of AMH in serum
Measured: before treatment and 3, 6, 12 and 24 months after treatment
Secondary outcomes (2)
Thyroid function
Measure the level of TSH、T3、T4、FT3、FT4、TGAB、TPOAB in serum
Measured: 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.
Measured: up to 24 months after the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start20 Feb 2025 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid GlandStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Minghua Ge, Study chair, Zhejiang Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06845098
- Sponsor's protocol ID
- KY2024117-Ge
- Status last verified
- Feb 2025
- First submitted
- 10 Feb 2025
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Thyroid Treatment on Ovarian Function and Pregnancy Outcomes in Women with Differentiated Thyroid Cancer: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06845098
- Acronym / sponsor ID
- KY2024117-Ge
- Conditions
- Thyroid Gland
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Zhejiang Provincial People's HospitalUniversity, hospital or other
- Study start
- 20 Feb 2025 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 25 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Thyroid one-sided lobe + isthmus resection | Experimental | Procedure: Thyroid one-sided lobe + isthmus resectionThyroid one-sided lobe + isthmus resection |
| Total thyroidectomy | Experimental | Procedure: Total thyroidectomyTotal thyroidectomy |
| Total thyroidectomy + RAIT | Experimental | Procedure: Total thyroidectomy + RAITTotal thyroidectomy + RAIT |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total thyroidectomyTotal thyroidectomy | Procedure or surgery | Total thyroidectomy |
| Total thyroidectomy + RAITTotal thyroidectomy + RAIT | Procedure or surgery | Total thyroidectomy + RAIT |
| Thyroid one-sided lobe + isthmus resectionThyroid one-sided lobe + isthmus resection | Procedure or surgery | Thyroid one-sided lobe + isthmus resection |
Primary outcome
AMH level
Time frame: before treatment and 3, 6, 12 and 24 months after treatment
Measure the concentration of AMH in serum
2 secondary outcomes
Thyroid function
Time frame: before tratment and 3, 6, 12 and 24 months after treatment
clinical pregnancy rate
Time frame: up to 24 months after the treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Minghua Ge study chair
Zhejiang Provincial People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total thyroidectomy, Total thyroidectomy + RAIT and Thyroid one-sided lobe + isthmus resection in people with Thyroid Gland, run by Zhejiang Provincial People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Minghua Ge (86+15673187412, tingtingzhou2019@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AMH level (time frame: before treatment and 3, 6, 12 and 24 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2025.