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A Clinical Study on Fire - needle Intervention for Premature Ovarian Insufficiency (POI) Based on Menstrual Cycle Theory

A Clinical Study on Fire - needle Intervention for Premature Ovarian Insufficiency (POI) Based on Menstrual Cycle Theory

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025002146
Enrollment
Unknown
Registered
2025-11-08
Start date
2023-10-16
Completion date
Unknown
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premature Ovarian Insufficiency

Interventions

Follicular + ovulation group:Follicular and ovulatory millifurcation needle interventions
Ovulation group:Ovulation Millifire Needle Intervention
Follicular phase + ovulation + luteal phase:Three-phase millifire needle intervention

Sponsors

Nanjing Pukou Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1)Those who meet the diagnosis of infertility due to early onset ovarian function in Western medicine and those who belong to the above mentioned patterns in Chinese medicine; 2) Women of childbearing age between 18 and 40 years old; 3) The male partner has normal reproductive function; 4) Anti-mullerian hormone 1.1ng/ml<AMH<2ng/ml; 5) Sinus follicle number AFC<4; 6) Those who agree to receive treatment and follow-up observation according to this protocol; 7) Willing to sign the informed consent form; 8) Willing to sign an informed consent form; (viii) Willing to register the case.

Exclusion criteria

Exclusion criteria: Women who are pregnant at the time of consultation; routine gynecological examination by imaging secretion examination and other routine gynecological examination to determine that there is an organic lesion caused by POI; 2) the organic lesion caused by POI. Combined with organic diseases serious cardiac hepatic renal injuries endocrine diseases and other pathologies affecting normal drug metabolism menstruation ovulation and fertility; Suffering from malignant tumors of reproductive organs for surgical treatment and psychiatric patients; The use of drugs that interfere with this treatment program or have received relevant treatment and may affect the indicators of effect observation; Failure to strictly implement the intervention and change the treatment plan resulting in failure to collect or error in the efficacy feedback effect indicators and other corresponding data. Participants who also participated in other experiments were unable to complete the various scales and were unwilling to be randomized.

Design outcomes

Primary

MeasureTime frame
FSH (Follicle stimulating hormone);LH (luteinizing hormone);E2 (estradiol);AMH (Anti-Mullerian hormone);AFC (antral follicle count);

Secondary

MeasureTime frame
Endometrial thickness (mm);Perimenopausal symptom Scale;Self-rating Anxiety Scale;TCM clinical symptom score;

Countries

China

Contacts

Public ContactZhu Qianyang

Nanjing Pukou Hospital of Traditional Chinese Medicine

zqy2738465571@163.com+86 188 4692 6614

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026