Status:
UNKNOWN
Sequential Therapy of TCM Herbs to Improve the Success Rate of IVF-ET in Diminished Ovarian Reserve Patients
Lead Sponsor:
Peking University Third Hospital
Conditions:
Infertility, Female
Eligibility:
FEMALE
20-40 years
Phase:
PHASE3
Brief Summary
In the early stage, our team found that traditional Chinese medicine (TCM) intervention aimed at Nourishing kidney and regulating blood circulation in vitro fertilization and embryo transfer(IVF-ET) c...
Detailed Description
The study will be conducted on patients with DOR attending our reproductive medicine centre for proposed IVF-ET between January 2021and December 2022. The trial is designed as a randomised, controlle...
Eligibility Criteria
Inclusion
- Consent to participate in this clinical trial and sign an informed consent form.
- Age ≤40 years, regular menstrual cycle between 21and 35 days in length.
- Meet the Western diagnostic criteria for DOR.
- Meet the criteria for identifying kidney deficiency in Chinese medicine.
- Planning to undergo IVF-ET for pregnancy.
Exclusion
- History of two or more previous spontaneous abortions (excluding biochemical pregnancy abortions) or three or more previous ETs without obtaining a clinical pregnancy.
- Premature ovarian failure or ovarian gonadotropin resistance syndrome.
- Untreated uterine anomalies or abnormalities, including double uterus or longitudinal uterus (complete or incomplete).
- Untreated hydrocele on one or both fallopian tubes (confirmed by hysterosalpingography).
- Uterine adhesions, endometriosis, adenomyosis, endometrial lesions (submucosal fibroids, endometrial polyps, etc.), or uterine fibroids \>4 cm.
- Endocrine disorder affecting ovulation, such as polycystic ovary syndrome, hyperprolactinaemia, hyperandrogenaemia, hypothyroidism, or adrenal abnormalities.
- Infertility with abnormal ovarian function due to immune factors, genetic factors, or congenital physical defects.
- Previous pelvic radiotherapy.
- Known or suspected sex hormone-related malignancy.
- Allergy to or intolerance of the drugs used in the study.
- Combined contraindications to assisted reproductive technology or pregnancy, such as uncontrolled abnormalities of liver and kidney function, diabetes mellitus (glycosylated haemoglobin ≤7%, fasting blood glucose \<10 mmol/L ), hypertension, thyroid disease, symptomatic heart disease, moderate to severe anaemia, history of malignancy or thromboembolism or propensity to thrombosis, severe psychiatric disorder, acute infections of the genitourinary system, sexually transmitted diseases, serious adverse habits such as drug abuse, exposure to teratogenic amounts of radiation, toxins, or drugs (such as prednisone or other hormones, adrenaline, antibiotics, or hypertension, cardiovascular, or antiviral medications) during the active procedure period , and uterine factor infertility or physical illness which prevents the ability to bear a pregnancy.
Key Trial Info
Start Date :
April 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2022
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04842825
Start Date
April 15 2021
End Date
December 30 2022
Last Update
June 18 2021
Active Locations (1)
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1
Peking University Third Hospital
Beijing, China, China