Sequential Therapy of TCM Herbs to Improve the Success Rate of IVF-ET in Diminished Ovarian Reserve Patients

• Status: Recruiting
• Trial end date: 2022-12-30
• Target enrollment: 0
• Participant gender: Female

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) can improve the clinical pregnancy rate. In order to further study the role of TCM in improving the pregnancy outcome of IVF-ET in infertility due to decreased ovarian reserve (DOR). A randomized controlled clinical trial was used in this study. 200 infertile patients with DOR were randomly divided into two groups. The control group was treated with conventional modern medicine, and the treatment group was treated with traditional Chinese herbs on the basis of conventional modern medicine.

The intervention started from the 5th day of the first menstrual cycles after enrollment and lasted for three months before IVF-ET. After the transplantation, the TCM treatment continues for 14 days. The number of oocytes, antral follicles, anti-Mullerian hormone(AMH), serum follicle-stimulating hormone(FSH), and clinical pregnancy rate will be observed to evaluate the effect of traditional Chinese medicine on the improvement of ovarian function, pregnancy outcome, and fertility of DOR patients.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking University Third Hospital
• Treatments: Cetrorelix; Follicle Stimulating Hormone

Criteria

Inclusion Criteria:

1. Consent to participate in this clinical trial and sign an informed consent form.

2. Age ≤40 years, regular menstrual cycle between 21and 35 days in length.

3. Meet the Western diagnostic criteria for DOR.

4. Meet the criteria for identifying kidney deficiency in Chinese medicine.

5. Planning to undergo IVF-ET for pregnancy.

Exclusion Criteria:

1. History of two or more previous spontaneous abortions (excluding biochemical pregnancy abortions) or three or more previous ETs without obtaining a clinical pregnancy.

2. Premature ovarian failure or ovarian gonadotropin resistance syndrome.

3. Untreated uterine anomalies or abnormalities, including double uterus or longitudinal uterus (complete or incomplete).

4. Untreated hydrocele on one or both fallopian tubes (confirmed by hysterosalpingography).

5. Uterine adhesions, endometriosis, adenomyosis, endometrial lesions (submucosal fibroids, endometrial polyps, etc.), or uterine fibroids >4 cm.

6. Endocrine disorder affecting ovulation, such as polycystic ovary syndrome, hyperprolactinaemia, hyperandrogenaemia, hypothyroidism, or adrenal abnormalities.

7. Infertility with abnormal ovarian function due to immune factors, genetic factors, or congenital physical defects.

8. Previous pelvic radiotherapy.

9. Known or suspected sex hormone-related malignancy.

10. Allergy to or intolerance of the drugs used in the study.

11. 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.