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Kuntai capsule treatment of decline in ovarian reserve clinical trial

Evaluation of kuntai capsule treatment of decline in ovarian reserve(liver and kidney Yin deficiency, disharmony between the heart and kidney) efficacy and safety of random, open, positive drug parallel controlled clinical trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-13004085
Enrollment
Unknown
Registered
2013-12-07
Start date
2014-01-06
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

decline in ovarian reserve

Interventions

Experimental group :Kuntai capsule
The control group :DHEA

Sponsors

The First affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
25 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1. female patients aged 25~40 years old; 2. with the clinical manifestations,such as menstrual disorders, infertility, lumbar debility,hot flashes sweat out; 3. Conforms to the diagnosis standard of DOR; 4. belong to the liver and kidney Yin deficiency, disharmony between the heart and kidney syndrome differentiation of traditional Chinese medicine; 5. for nearly three months did not use a hormonal drugs (except for in vitro fertilization and embryo transplantation; 6. Voluntary participants, and agreed to sign the informed consent of the patients.

Exclusion criteria

Exclusion criteria: 1. polycystic ovary syndrome,hyperprolactimia, hyperandrogenism, hypothyroidism and other endocrine diseases affecting ovulation; 2. the iatrogenic factors (such as pelvic surgery, radiation and chemotherapy, uterine artery embolization, etc.) which can cause DOR; 3. taken nearly three months hormone drugs such as birth control pills, glucocorticoid (except for in vitro fertilization and embryo transplantation requirement); 4. with internal medicine, surgery, psychiatric serious primary diseases; 5. to the research of the formulas of known drug allergies; 6. galactosemia and mucopolysaccharide diseases such as the flaw of the enzyme and infertility caused by a hereditary factors; 7. do not belong to the liver and kidney Yin deficiency, disharmony between the heart and kidney syndrome differentiation of traditional Chinese medicine.

Design outcomes

Primary

MeasureTime frame
Hormonal profile: Follicle stimulating hormone(FSH), luteinizing hormone (LH), Testosterone(T), Estrogen(E2), Anti-mullerianhormone(AMH) , Dhydroepiandrosterone sulfate(DHEAS), andINHB;Bilateral ovarian antral follicle numbers;estradiol levels of the day use HCG;the number of oocytes;the number of embryos;implantation rate of embryo;clinical pregnancy rate;effect of the disease;effect of the syndromes of traditional Chinese Medicine;effect of the single traditional Chinese medicine;

Countries

China

Contacts

Public ContactXia Tian

The First affiliated Hospital of Tianjin University of Traditional Chinese Medicine

xiatian1976@yahoo.com.cn+86 15822238896

Outcome results

None listed

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