Premature Ovarian InsufficiencyPOINCT06067529
A Multicenter Observational Study on the Development and Health Effects of Premature Ovarian Insufficiency
An observational study of Premature Ovarian Insufficiency, run by Women's Hospital School Of Medicine Zhejiang University at 2 sites in China.
Trial summary
Premature ovarian insufficiency (POI) refers to the occurrence of ovarian hypofunction in women before the age of 40, which seriously affects women's overall health and quality of life. Read more about this study
- Who is it for?
- Ages 10 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Premature Ovarian Insufficiency
- How many people
- 1,080 participants
- Where
- 2 sitesChina
- Study dates
- 10 Oct 2023to 31 Dec 2026
- Phase
- Observational
- 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 10 to 65 years
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Women with POI; Control; Ovarian Surgery group; Oophorectomy group
Women with POI
- Inclusion Criteria 1.1 Age at Diagnosis: Less than 40 years of age. 1.2 Diagnosis of POI: Met one of the following diagnostic criteria based on ESHRE guidelines: Spontaneous POI: Oligomenorrhea or amenorrhea for at least 4 months, combined with elevated FSH levels (> 25 IU/L) on two occasions at least 4 weeks apart. Iatrogenic POI: Documented history of bilateral oophorectomy, or ovarian failure resulting from chemotherapy or radiotherapy. 1.3 Informed Consent: Willing to participate in the study, provide biological samples, and complete long-term follow-up assessments.
- Exclusion Criteria 2.1 Current Pregnancy or Lactation: Women who were pregnant or breastfeeding at the time of enrollment.
2.2 Severe Systemic Conditions: Presence of severe somatic or psychiatric diseases (e.g., active malignancy not related to POI, severe heart/renal failure, or cognitive impairment) that would preclude adherence to the study protocol or long-term follow-up.
Control
- Inclusion Criteria: 1.1 Age: 18-50 years. 1.2 Menstrual History: Regular menstrual cycles (21-35 days) for the past 12 months. 1.3 Consent: Willingness to participate, provide biological samples, and provide written informed consent.
- Exclusion Criteria:
2.1 Physiological Status: Pregnancy, breastfeeding, or clinical perimenopause/postmenopause.
2.2 Reproductive Disorders: History of PCOS, endometriosis, or other reproductive pathologies.
2.3 Iatrogenic \& Toxic Factors: Prior ovarian surgery (e.g., cystectomy), chemotherapy, or radiotherapy.
2.4 Systemic Diseases: History of endocrine (e.g., thyroid dysfunction), autoimmune, cardiovascular, liver, kidney, or hematological diseases, or malignancy.
2.5 Genetic \& Familial Background: First-degree relatives with POI or early menopause (< 45 years). Family history of hereditary diseases. 2.6 Medication: Use of hormonal drugs or contraceptives within the last 6 months.
Ovarian Surgery group
- Inclusion Criteria: 1.1 Age: 18-60 years. 1.2 Patients with ovarian surgery: women scheduled to undergo ovarian surgery for gynecological disease. 1.3 Informed Consent: Willing to participate in the study, provide biological samples, and sign the informed consent.
- Exclusion Criteria:
2.1 Reproductive Disorders: History of PCOS, endometriosis, or other reproductive pathologies.
2.2 Medication: Use of hormonal drugs or contraceptives within the last 6 months.
2.3 Genetic or chromosomal abnormalities: Turner syndrome, or other genetic disease.
2.4 Physiological Status: Pregnancy, breastfeeding, or seeking the help of assisted reproductive technology.
2.5 Severe systemic Diseases: History of endocrine (e.g., thyroid dysfunction), autoimmune, cardiovascular, liver, kidney, hematological diseases, malignancy, or cognitive impairment.
Oophorectomy group
- Inclusion Criteria: 1.1 Age: 45-65 years. 1.2 Patients with oophorectomy: women scheduled to undergo oophorectomy due to gynecological diseases and met criteria for being menopausal. 1.3 Menopausal status: at least 12 consecutive months of amenorrhea without other medical causes. 1.3 Informed Consent: Willing to participate in the study, provide biological samples, and sign the informed consent.
- Exclusion Criteria:
2.1 Reproductive Disorders: History of PCOS, endometriosis, or other reproductive pathologies.
2.2 Medication: Use of hormonal drugs or contraceptives within the last 6 months.
2.3 Genetic or chromosomal abnormalities: Turner syndrome, or other genetic disease 2.4 Physiological Status: Pregnancy, breastfeeding, or seeking the help of assisted reproductive technology.
2.5 Severe systemic Diseases: History of endocrine (e.g., thyroid dysfunction), autoimmune, cardiovascular, liver, kidney, hematological diseases, malignancy, or cognitive impairment.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Women's Hospital School of Medicine Zhejiang University
Hangzhou, Zhejiang, 310000
Jianhong Zhou, Doctor of Medicine(M.D.), 86 15990008569, zhoujh1117@zju.edu.cn
Yizhou Huang, Doctor of Medicine(M.D.), 86 15267073860, cchhkkxx@126.com
- Not yet recruiting
Women's Hospital School of Medicine Zhejiang University
Hangzhou, Zhejiang, 310000
Jianhong Zhou, MD,PhD, 15990008569, zhoujh1117@zju.edu.cn
About this study
Premature ovarian insufficiency (POI) refers to the occurrence of ovarian hypofunction in women before the age of 40, which seriously affects women's overall health and quality of life. However, there is currently insufficient understanding of the risk factors, pathogenesis, short-term and long-term health effects of POI, and the health effects of the disease, and there is a lack of high-quality evidence to support clinical diagnosis and treatment decisions. This study intends to construct a hospital-based multi-center POI case-control and prospective special disease cohort, after baseline assessment and follow-up monitoring, collect disease characteristics, lifestyle, social psychology, environmental and occupational exposure, biological samples and other data, aiming to observe POI The natural occurrence, progression and health impact of POI, clarify the risk factors of POI, evaluate the impact of POI on women's health and disease risk, and discuss the benefits, risks and options of HRT for POI patients. The results of this study will deepen and expand the understanding of the occurrence and development of POI and its short-term and long-term health effects, provide high-level evidence for optimizing POI prevention, diagnosis and treatment strategies, and establish a long-term management system, laying the foundation for interventional research.
- Conditions
- Premature Ovarian Insufficiency
- Keywords
- Premature Ovarian Insufficiency
- Medical subject headings
- Primary Ovarian Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Women with POI | 1. Inclusion Criteria 1.1 Age at Diagnosis: Less than 40 years of age. 1.2 Diagnosis of POI: Met one of the following diagnostic criteria based on ESHRE guidelines: Spontaneous POI: Oligomenorrhea or amenorrhea for at least 4 months, combined with elevated FSH levels (> 25 IU/L) on two occasions at least 4 weeks apart. Iatrogenic POI: Documented history of bilateral oophorectomy, or ovarian failure resulting from chemotherapy or radiotherapy. 1.3 Informed Consent: Willing to participate in the study, provide biological samples, and complete long-term follow-up assessments. 2. Exclusion Criteria 2.1 Current Pregnancy or Lactation: Women who were pregnant or breastfeeding at the time of enrollment. 2.2 Severe Systemic Conditions: Presence of severe somatic or psychiatric diseases (e.g., active malignancy not related to POI, severe heart/renal failure, or cognitive impairment) that would preclude adherence to the study protocol or long-term follow-up. | |
| Control | 1. Inclusion Criteria: 1.1 Age: 18-50 years. 1.2 Menstrual History: Regular menstrual cycles (21-35 days) for the past 12 months. 1.3 Consent: Willingness to participate, provide biological samples, and provide written informed consent. 2. Exclusion Criteria: 2.1 Physiological Status: Pregnancy, breastfeeding, or clinical perimenopause/postmenopause. 2.2 Reproductive Disorders: History of PCOS, endometriosis, or other reproductive pathologies. 2.3 Iatrogenic \& Toxic Factors: Prior ovarian surgery (e.g., cystectomy), chemotherapy, or radiotherapy. 2.4 Systemic Diseases: History of endocrine (e.g., thyroid dysfunction), autoimmune, cardiovascular, liver, kidney, or hematological diseases, or malignancy. 2.5 Genetic \& Familial Background: First-degree relatives with POI or early menopause (< 45 years). Family history of hereditary diseases. 2.6 Medication: Use of hormonal drugs or contraceptives within the last 6 months. | |
| Ovarian Surgery group | 1. Inclusion Criteria: 1.1 Age: 18-60 years. 1.2 Patients with ovarian surgery: women scheduled to undergo ovarian surgery for gynecological disease. 1.3 Informed Consent: Willing to participate in the study, provide biological samples, and sign the informed consent. 2. Exclusion Criteria: 2.1 Reproductive Disorders: History of PCOS, endometriosis, or other reproductive pathologies. 2.2 Medication: Use of hormonal drugs or contraceptives within the last 6 months. 2.3 Genetic or chromosomal abnormalities: Turner syndrome, or other genetic disease. 2.4 Physiological Status: Pregnancy, breastfeeding, or seeking the help of assisted reproductive technology. 2.5 Severe systemic Diseases: History of endocrine (e.g., thyroid dysfunction), autoimmune, cardiovascular, liver, kidney, hematological diseases, malignancy, or cognitive impairment. | |
| Oophorectomy group | 1. Inclusion Criteria: 1.1 Age: 45-65 years. 1.2 Patients with oophorectomy: women scheduled to undergo oophorectomy due to gynecological diseases and met criteria for being menopausal. 1.3 Menopausal status: at least 12 consecutive months of amenorrhea without other medical causes. 1.3 Informed Consent: Willing to participate in the study, provide biological samples, and sign the informed consent. 2. Exclusion Criteria: 2.1 Reproductive Disorders: History of PCOS, endometriosis, or other reproductive pathologies. 2.2 Medication: Use of hormonal drugs or contraceptives within the last 6 months. 2.3 Genetic or chromosomal abnormalities: Turner syndrome, or other genetic disease 2.4 Physiological Status: Pregnancy, breastfeeding, or seeking the help of assisted reproductive technology. 2.5 Severe systemic Diseases: History of endocrine (e.g., thyroid dysfunction), autoimmune, cardiovascular, liver, kidney, hematological diseases, malignancy, or cognitive impairment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone density
Measured by Dual Energy X-ray Unit: g/cm²
Measured: Baseline, 12 months, 24 months, 36 months
β-collagen degradation products
Bone resorption marker , β-collagen degradation products, are measured in peripheral venous blood.
Unit: pg/mL
Measured: Baseline, 12 months, 24 months, 36 months
Osteocalcin
Bone formation markers, Osteocalcin, are measured in peripheral venous blood. Unit: ng/mL
Measured: Baseline, 12 months, 24 months, 36 months
Total type I collagen amino-terminal propeptide
Bone formation markers, Total type I collagen amino-terminal propeptide, are measured in peripheral venous blood.
Unit: μg/L
Measured: Baseline, 12 months, 24 months, 36 months
Reproductive hormones
Reproductive hormones, including follicle-stimulating hormone (FSH), luteinizing hormone (LH), estradiol (E2), progesterone (P), and testosterone (T), are measured in peripheral venous blood. These hormones are assessed together to evaluate female hormonal status.
Measured: Baseline, 6 months, 12 months, 24 months, 36 months
Thyroid function test
Thyroid-stimulating hormone (TSH), free triiodothyronine (FT3), and free thyroxine (FT4) are measured in peripheral venous blood. Results will be compared with reference ranges to evaluate thyroid function.
Measured: Baseline, 12 months, 24 months, 36 months
Symptoms related to low estrogen
The symptoms related to low estrogen was quantified using the modified Kupperman Menopausal Index (mKMI). The total score is used to classify the symptom severity into four levels: asymptomatic (≤ 6), mild (7-15), moderate (16-30), and severe (≥ 31). A higher total score indicates more severe symptoms.
Measured: Baseline, 6 months, 12 months, 24 months, 36 months
Sexual life
The assessment of Sexual life was conducted using the 6-item Female Sexual Function Index (FSFI-6). A total score ranging from 2 to 30, and a total score of 19 or less was defined as the diagnostic cutoff for identifying individuals with female sexual dysfunction.
Measured: Baseline, 12 months, 24 months, 36 months
Fasting blood glucose
Fasting blood glucose is measured in peripheral venous blood. Results are compared with reference ranges to assess glucose metabolism.
Unit: mmol/L
Measured: Baseline, 6 months, 12 months, 24 months, 36 months
Insulin
Insulin is measured in peripheral venous blood. Results are compared with reference ranges to assess glucose metabolism.
Unit: μU/mL
Measured: Baseline, 6 months, 12 months, 24 months, 36 months
Depressive symptoms
Depressive symptoms were assessed using the 10-item Center for Epidemiologic Studies Depression Scale Revised (CES-D-10) . Total scores range from 0 to 30, and a cutoff score of ≥ 10 was utilized to identify individuals at risk for depression.
Measured: Baseline, 6 months, 12 months, 24 months, 36 months
Anxiety
Anxiety was evaluated using the Generalized Anxiety Disorder-7 (GAD-7). Total scores were categorized into four levels consisting of minimal anxiety (0-4), mild anxiety (5-9), moderate anxiety (10-14) and severe anxiety (≥ 15).
Measured: Baseline, 6 months, 12 months, 24 months, 36 months
Subjective psychological well-being
Subjective psychological well-being over the preceding two weeks was quantified through the World Health Organization Five Well-Being Index (WHO-5).A total raw score of < 13 was considered indicative of potential psychological health issues.
Measured: Baseline, 6 months, 12 months, 24 months, 36 months
Number of Participants with Affected Hepatic Function Tests After Treatment
Hepatic function parameters are measured in peripheral venous blood. Affected is defined as any value outside the reference ranges below. The number of participants with at least one affected result attributed to HRT will be reported.
Parameters and reference ranges:
Total protein: 65.0-85.0 g/L Albumin: 40.0-55.0 g/L Albumin/Globulin ratio: 1.20-2.40 (unitless) Alanine aminotransferase (ALT): 7-40 U/L Aspartate aminotransferase (AST): 13-35 U/L Total bilirubin: ≤23.0 μmol/L Direct bilirubin: ≤4.0 μmol/L Indirect bilirubin: ≤19.0 μmol/L Alkaline phosphatase (ALP): 35-100 U/L Gamma-glutamyl transferase (GGT): 7-45 U/L
Measured: Baseline, 6 months, 12 months, 24 months, 36 months
Number of Participants with Affected Renal Function Tests After Treatment
Renal function parameters are measured in peripheral venous blood. Affected is defined as any value outside the reference ranges below. The number of participants with at least one abnormal result attributed to HRT will be reported.
Parameters and reference ranges:
Creatinine: 41-73 μmol/L Urea: 2.60-7.50 mmol/L Uric acid: 155-357 μmol/L
Measured: Baseline, 6 months, 12 months, 24 months, 36 months
Secondary outcomes (3)
Number of Participants with Affected Complete Blood Count After Treatment
Complete blood count (CBC) parameters are measured in peripheral venous blood. A participant is considered to have affected CBC if any of the following parameters falls outside the established reference range listed below. The number of participants with at least one affected test result after treatment will be reported.
Parameters and reference ranges:
White blood cell count: 3.5-9.5 × 10⁹/L Red blood cell count: 3.80-5.10 × 10¹²/L Hemoglobin: 115-150 g/L Platelet count: 125-350 × 10⁹/L
Measured: Baseline, 6 months, 12 months, 24 months, 36 months
Ultrasound examination of pelvic
Ultrasound examination of pelvic is performed. Results are compared with reference imaging standards to assess and monitor participants' pelvic health.
Measured: Baseline, 6 months, 12 months, 24 months, 36 months
Ultrasound examination of breast
Ultrasound examination of breast is performed. Results are compared with reference imaging standards to assess and monitor participants' breast health.
Measured: Baseline, 6 months, 12 months, 24 months, 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2023
- Study start10 Oct 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature Ovarian InsufficiencyStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 1,080 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Women's Hospital School Of Medicine Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhou Jianhong, Women's Hospital School Of Medicine Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06067529
- Sponsor's protocol ID
- ZDFY2022-4XA101
- Acronym
- POI
- Status last verified
- May 2026
- First submitted
- 6 Jul 2023
- Last updated
- 28 May 2026
- 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 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Observational Study on the Development and Health Effects of Premature Ovarian Insufficiency
- ClinicalTrials.gov ID
- NCT06067529
- Acronym / sponsor ID
- POI / ZDFY2022-4XA101
- Conditions
- Premature Ovarian Insufficiency
- Keywords
- Premature Ovarian Insufficiency
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,080 participants (estimated)
- Lead sponsor
- Women's Hospital School Of Medicine Zhejiang UniversityUniversity, hospital or other
- Study start
- 10 Oct 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 5 Oct 2023 (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.
Premature ovarian insufficiency (POI) refers to the occurrence of ovarian hypofunction in women before the age of 40, which seriously affects women's overall health and quality of life. However, there is currently insufficient understanding of the risk factors, pathogenesis, short-term and long-term health effects of POI, and the health effects of the disease, and there is a lack of high-quality evidence to support clinical diagnosis and treatment decisions. This study intends to construct a hospital-based multi-center POI case-control and prospective special disease cohort, after baseline assessment and follow-up monitoring, collect disease characteristics, lifestyle, social psychology, environmental and occupational exposure, biological samples and other data, aiming to observe POI The natural occurrence, progression and health impact of POI, clarify the risk factors of POI, evaluate the impact of POI on women's health and disease risk, and discuss the benefits, risks and options of HRT for POI patients. The results of this study will deepen and expand the understanding of the occurrence and development of POI and its short-term and long-term health effects, provide high-level evidence for optimizing POI prevention, diagnosis and treatment strategies, and establish a long-term management system, laying the foundation for interventional research.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Women with POI | – | –1. Inclusion Criteria 1.1 Age at Diagnosis: Less than 40 years of age. 1.2 Diagnosis of POI: Met one of the following diagnostic criteria based on ESHRE guidelines: Spontaneous POI: Oligomenorrhea or amenorrhea for at least 4 months, combined with elevated FSH levels (> 25 IU/L) on two occasions at least 4 weeks apart. Iatrogenic POI: Documented history of bilateral oophorectomy, or ovarian failure resulting from chemotherapy or radiotherapy. 1.3 Informed Consent: Willing to participate in the study, provide biological samples, and complete long-term follow-up assessments. 2. Exclusion Criteria 2.1 Current Pregnancy or Lactation: Women who were pregnant or breastfeeding at the time of enrollment. 2.2 Severe Systemic Conditions: Presence of severe somatic or psychiatric diseases (e.g., active malignancy not related to POI, severe heart/renal failure, or cognitive impairment) that would preclude adherence to the study protocol or long-term follow-up. |
| Control | – | –1. Inclusion Criteria: 1.1 Age: 18-50 years. 1.2 Menstrual History: Regular menstrual cycles (21-35 days) for the past 12 months. 1.3 Consent: Willingness to participate, provide biological samples, and provide written informed consent. 2. Exclusion Criteria: 2.1 Physiological Status: Pregnancy, breastfeeding, or clinical perimenopause/postmenopause. 2.2 Reproductive Disorders: History of PCOS, endometriosis, or other reproductive pathologies. 2.3 Iatrogenic \& Toxic Factors: Prior ovarian surgery (e.g., cystectomy), chemotherapy, or radiotherapy. 2.4 Systemic Diseases: History of endocrine (e.g., thyroid dysfunction), autoimmune, cardiovascular, liver, kidney, or hematological diseases, or malignancy. 2.5 Genetic \& Familial Background: First-degree relatives with POI or early menopause (< 45 years). Family history of hereditary diseases. 2.6 Medication: Use of hormonal drugs or contraceptives within the last 6 months. |
| Ovarian Surgery group | – | –1. Inclusion Criteria: 1.1 Age: 18-60 years. 1.2 Patients with ovarian surgery: women scheduled to undergo ovarian surgery for gynecological disease. 1.3 Informed Consent: Willing to participate in the study, provide biological samples, and sign the informed consent. 2. Exclusion Criteria: 2.1 Reproductive Disorders: History of PCOS, endometriosis, or other reproductive pathologies. 2.2 Medication: Use of hormonal drugs or contraceptives within the last 6 months. 2.3 Genetic or chromosomal abnormalities: Turner syndrome, or other genetic disease. 2.4 Physiological Status: Pregnancy, breastfeeding, or seeking the help of assisted reproductive technology. 2.5 Severe systemic Diseases: History of endocrine (e.g., thyroid dysfunction), autoimmune, cardiovascular, liver, kidney, hematological diseases, malignancy, or cognitive impairment. |
| Oophorectomy group | – | –1. Inclusion Criteria: 1.1 Age: 45-65 years. 1.2 Patients with oophorectomy: women scheduled to undergo oophorectomy due to gynecological diseases and met criteria for being menopausal. 1.3 Menopausal status: at least 12 consecutive months of amenorrhea without other medical causes. 1.3 Informed Consent: Willing to participate in the study, provide biological samples, and sign the informed consent. 2. Exclusion Criteria: 2.1 Reproductive Disorders: History of PCOS, endometriosis, or other reproductive pathologies. 2.2 Medication: Use of hormonal drugs or contraceptives within the last 6 months. 2.3 Genetic or chromosomal abnormalities: Turner syndrome, or other genetic disease 2.4 Physiological Status: Pregnancy, breastfeeding, or seeking the help of assisted reproductive technology. 2.5 Severe systemic Diseases: History of endocrine (e.g., thyroid dysfunction), autoimmune, cardiovascular, liver, kidney, hematological diseases, malignancy, or cognitive impairment. |
Who may qualify
- Ages
- 10 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women with POI; Control; Ovarian Surgery group; Oophorectomy group
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Bone density
Time frame: Baseline, 12 months, 24 months, 36 months
Measured by Dual Energy X-ray Unit: g/cm²
β-collagen degradation products
Time frame: Baseline, 12 months, 24 months, 36 months
Bone resorption marker , β-collagen degradation products, are measured in peripheral venous blood. Unit: pg/mL
Osteocalcin
Time frame: Baseline, 12 months, 24 months, 36 months
Bone formation markers, Osteocalcin, are measured in peripheral venous blood. Unit: ng/mL
Total type I collagen amino-terminal propeptide
Time frame: Baseline, 12 months, 24 months, 36 months
Bone formation markers, Total type I collagen amino-terminal propeptide, are measured in peripheral venous blood. Unit: μg/L
Reproductive hormones
Time frame: Baseline, 6 months, 12 months, 24 months, 36 months
Reproductive hormones, including follicle-stimulating hormone (FSH), luteinizing hormone (LH), estradiol (E2), progesterone (P), and testosterone (T), are measured in peripheral venous blood. These hormones are assessed together to evaluate female hormonal status.
Thyroid function test
Time frame: Baseline, 12 months, 24 months, 36 months
Thyroid-stimulating hormone (TSH), free triiodothyronine (FT3), and free thyroxine (FT4) are measured in peripheral venous blood. Results will be compared with reference ranges to evaluate thyroid function.
Symptoms related to low estrogen
Time frame: Baseline, 6 months, 12 months, 24 months, 36 months
The symptoms related to low estrogen was quantified using the modified Kupperman Menopausal Index (mKMI). The total score is used to classify the symptom severity into four levels: asymptomatic (≤ 6), mild (7-15), moderate (16-30), and severe (≥ 31). A higher total score indicates more severe symptoms.
Sexual life
Time frame: Baseline, 12 months, 24 months, 36 months
The assessment of Sexual life was conducted using the 6-item Female Sexual Function Index (FSFI-6). A total score ranging from 2 to 30, and a total score of 19 or less was defined as the diagnostic cutoff for identifying individuals with female sexual dysfunction.
Fasting blood glucose
Time frame: Baseline, 6 months, 12 months, 24 months, 36 months
Fasting blood glucose is measured in peripheral venous blood. Results are compared with reference ranges to assess glucose metabolism. Unit: mmol/L
Insulin
Time frame: Baseline, 6 months, 12 months, 24 months, 36 months
Insulin is measured in peripheral venous blood. Results are compared with reference ranges to assess glucose metabolism. Unit: μU/mL
Depressive symptoms
Time frame: Baseline, 6 months, 12 months, 24 months, 36 months
Depressive symptoms were assessed using the 10-item Center for Epidemiologic Studies Depression Scale Revised (CES-D-10) . Total scores range from 0 to 30, and a cutoff score of ≥ 10 was utilized to identify individuals at risk for depression.
Anxiety
Time frame: Baseline, 6 months, 12 months, 24 months, 36 months
Anxiety was evaluated using the Generalized Anxiety Disorder-7 (GAD-7). Total scores were categorized into four levels consisting of minimal anxiety (0-4), mild anxiety (5-9), moderate anxiety (10-14) and severe anxiety (≥ 15).
Subjective psychological well-being
Time frame: Baseline, 6 months, 12 months, 24 months, 36 months
Subjective psychological well-being over the preceding two weeks was quantified through the World Health Organization Five Well-Being Index (WHO-5).A total raw score of < 13 was considered indicative of potential psychological health issues.
Number of Participants with Affected Hepatic Function Tests After Treatment
Time frame: Baseline, 6 months, 12 months, 24 months, 36 months
Hepatic function parameters are measured in peripheral venous blood. Affected is defined as any value outside the reference ranges below. The number of participants with at least one affected result attributed to HRT will be reported. Parameters and reference ranges: Total protein: 65.0-85.0 g/L Albumin: 40.0-55.0 g/L Albumin/Globulin ratio: 1.20-2.40 (unitless) Alanine aminotransferase (ALT): 7-40 U/L Aspartate aminotransferase (AST): 13-35 U/L Total bilirubin: ≤23.0 μmol/L Direct bilirubin: ≤4.0 μmol/L Indirect bilirubin: ≤19.0 μmol/L Alkaline phosphatase (ALP): 35-100 U/L Gamma-glutamyl transferase (GGT): 7-45 U/L
Number of Participants with Affected Renal Function Tests After Treatment
Time frame: Baseline, 6 months, 12 months, 24 months, 36 months
Renal function parameters are measured in peripheral venous blood. Affected is defined as any value outside the reference ranges below. The number of participants with at least one abnormal result attributed to HRT will be reported. Parameters and reference ranges: Creatinine: 41-73 μmol/L Urea: 2.60-7.50 mmol/L Uric acid: 155-357 μmol/L
3 secondary outcomes
Number of Participants with Affected Complete Blood Count After Treatment
Time frame: Baseline, 6 months, 12 months, 24 months, 36 months
Ultrasound examination of pelvic
Time frame: Baseline, 6 months, 12 months, 24 months, 36 months
Ultrasound examination of breast
Time frame: Baseline, 6 months, 12 months, 24 months, 36 months
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 28 May 2026.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Premature Ovarian Insufficiency, run by Women's Hospital School Of Medicine Zhejiang University at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: looking for participants now, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Jianhong Zhou, Doctor of Medicine(M.D.) (86 15990008569, zhoujh1117@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone density (time frame: Baseline, 12 months, 24 months, 36 months). The study lists 15 primary outcomes in all. 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 28 May 2026.