Major study launches to unravel mysteries of early menopause
NCT ID NCT06067529
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study follows 1080 women diagnosed with premature ovarian insufficiency (POI) before age 40. Researchers will track their health over time, including bone density, hormone levels, and mental well-being. The goal is to identify risk factors and understand how POI affects overall health, which could lead to better care and treatment strategies.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this study could provide clearer guidelines for diagnosing and managing premature ovarian insufficiency, improving long-term health outcomes for affected women.
- What could go wrong
- This is an observational study, not a treatment trial. It cannot prove cause and effect, and results may take years to influence clinical practice.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 1,080 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2023
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Women with POI; Control; Ovarian Surgery group; Oophorectomy group
- Ages
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10 to 65 years
- Sex
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Female participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Women's Hospital School of Medicine Zhejiang University
RECRUITINGHangzhou, Zhejiang, 310000, China
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Women's Hospital School of Medicine Zhejiang University
NOT_YET_RECRUITINGHangzhou, Zhejiang, 310000, China
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Other studies related to the condition(s) this trial covers.
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- Kidney drug tested to restart egg growth in early menopause
- Can umbilical cord stem cells revive failing ovaries?
- DNA hunt for why some women face early menopause
- Stem cell shot into ovaries aims to tame perimenopause symptoms
- Could stem cell exosomes restore fertility? new trial tests hope for early ovarian failure