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A study on the efficacy and safety of Bu Xue Yi Mu Wan in patients with IVF-ET failure-A multicenter randomized double-blind parallel controlled trial.

A study on the efficacy and safety of Bu Xue Yi Mu Wan in patients with IVF-ET failure-A multicenter randomized double-blind parallel controlled trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2024000538
Enrollment
Unknown
Registered
2024-10-12
Start date
2024-10-15
Completion date
Unknown
Last updated
2024-11-11

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

Conditions

patients with IVF-ET failure

Interventions

Control:Bu Xue Yi Mu Wan placebo+HRT therapy
Test group:Bu Xue Yi Mu Wan+HRT therapy

Sponsors

The Third Affiliated Hospital of Zhengzhou University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 38 Years

Inclusion criteria

Inclusion criteria: 1.Age 20-38 years (inclusive of boundary values 2. Body mass index 18.5 = BMI < 30.0 kg/m² 3. Failed first IVF/ICSI embryo (1 fresh or frozen embryo) transfer cycle 4.Conforms to the TCM syndrome of "Qi and blood deficiency with blood stasis" (qualitative judgment: at least one main symptom and at least two secondary symptoms must be met for diagnosis) 5.=1 D5-6 blastocysts (4BC or above) stored in the center

Exclusion criteria

Exclusion criteria: 1.Polycystic ovary syndrome (PCOS) diagnosed according to the Rotterdam criteria 2.History of recurrent miscarriage (defined as 2 or more consecutive pregnancy losses before 28 weeks of gestation with the same partner including biochemical pregnancies) 3.Unhealed intrauterine adhesions endometrial polyps 4. Uterine adenomyosis uterine fibroids compressing the uterine cavity line endometriosis (previously diagnosed as ASRM III-IV stage by surgery) 5.Uterine structural abnormalities including septate uterus unicornuate uterus bicornuate uterus 6.Visible tubal hydrosalpinx under ultrasound that has not been treated 7. Patients with diseases that are currently unsuitable for assisted reproductive technology or pregnancy 8.History of autoimmune diseases such as antiphospholipid syndrome systemic lupus erythematosus rheumatism etc. and patients withthrombophilia 9. Patients who have taken TCM or patent Chinese medicine for infertility-related conditions within 14 days before randomization

Design outcomes

Primary

MeasureTime frame
Clinical pregnancy rate;

Secondary

MeasureTime frame
Ongoing pregnancy rate;Traditional Chinese Medicine (TCM) syndrome score;Endometrial thickness;Embryo implantation rate;Endometrial morphology;Subendometrial blood flow grading;Early miscarriage rate;Biochemical pregnancy rate;

Countries

China

Contacts

Public ContactHuang Hefeng

The Third Affiliated Hospital of Zhengzhou University

huanghefg@hotmail.com+86 180 1731 0186

Outcome results

None listed

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