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A multicenter randomized double-blind placebo-controlled parallel clinical trial of Yunkang Oral Liquid in the treatment of recurrent miscarriage combined with diminished ovarian reserve function

A multicenter randomized double-blind placebo-controlled parallel clinical trial of Yunkang Oral Liquid in the treatment of recurrent miscarriage combined with diminished ovarian reserve function

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000728
Enrollment
Unknown
Registered
2025-04-13
Start date
2025-05-01
Completion date
Unknown
Last updated
2025-04-28

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

Conditions

Recurrent abortion combined with reduced ovarian reserve function

Interventions

Test group:Gekang Oral Liquid + Estradiol Tablets/Estradiol Diprogesterone Tablets Composite Packaging (Fenmatong)
Control group:Pregnancy oral liquid simulator + estradiol tablets/estradiol diprogesterone tablets compound packaging (fenmotong)

Sponsors

eking University Third Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria for recurrent abortion; 2. Meet the diagnostic criteria for reduced ovarian reserve function; 3. Those who are 3 months old from the last abortion are currently in the pregnancy preparation stage; 4. It conforms to the syndrome differentiation standards of traditional Chinese medicine for kidney deficiency syndrome and qi and blood weakness syndrome. 5. 20-45 years old; 6. Voluntaryly participate in this clinical trial give informed consent and sign a written informed consent form.

Exclusion criteria

Exclusion criteria: 1. Combine other reproductive internal divisions that affect the function of ovarian reserve or the evaluation of drug effectiveness Diseases of the urinary or metabolic immune system; 2. Chromosomal abnormalities enzyme defects (such as galactosemia etc.) tumors or due to surgery (such as eggs) Nest surgery uterine artery ligation tubal resection etc.) radiotherapy chemotherapy and other doctors Decreased ovarian reserve function caused by source factors; 3. Patients with serious diseases such as cardiovascular and cerebrovascular liver kidney hematopoiesis etc.; 4. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT)> 1.5 times the upper limit of normal reference value blood creatinine (Scr) > upper limit of normal reference value; 5. Pregnant or lactating women; 6. Known allergies or contraindications to experimental drugs; 7. Received Chinese and Western drugs for the treatment of ovarian reserve function within 1 month before joining the group; 8. Participated in other clinical trials within 3 months before randomization; 9. The researchers believe that it is not appropriate to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
Week 12 follicle-stimulant (FSH) change value;

Secondary

MeasureTime frame
Change value of anti-Müller tube hormone (AMH) in the 12th week;Disappearing rate of individual symptoms in Week 12;Clinical pregnancy rate during the trial;Changes in sinus follicle count (AFC) in the 12th week;Clinical pregnancy time;The incidence of early pregnancy abortion;The change value and efficiency of the score of traditional Chinese medicine syndrome in the 12th week;

Countries

China

Contacts

Public ContactLi Rong

eking University Third Hospital

roseli001@sina.com13701085402

Outcome results

None listed

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