Efficacy of Traditional Chinese Medicine on Ameliorating IVF-ET Outcomes of Diminished Ovarian Reserve Patients

• Status: Not yet recruiting
• Trial end date: 2024-12-30
• Target enrollment: 0
• Participant gender: Female

Summary

Patients with diminished ovarian reserve (DOR) who undergo in vitro fertilization and embryo transfer (IVF-ET) are included as the research subjects. The effects of Traditional Chinese Medicine (TCM) for kidney tonifying and blood circulation regulating of different intervention courses on ovarian hyporesponsiveness, IVF-ET outcome and clinical compliance in DOR patients are studied by a non-inferiority randomized controlled trial. The purpose is to identify the breakthrough point and treatment timing of TCM treatment, explore the best treatment course of TCM, and optimize the TCM therapeutic regimen.

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

Details

• Lead Sponsor: Peking University Third Hospital

Criteria

Inclusion Criteria:

1. Female, 20 years old ≤ age ≤ 42 years old;

2. The menstrual cycle is generally regular; 21 days < menstrual cycle < 35 days;

3. Those who meet the diagnostic criteria for DOR in Western medicine;

4. Those who meet the TCM differential criteria of kidney deficiency syndrome;

5. Those who are scheduled to undergo IVF-ET;

6. Those who voluntarily participate in this clinical trial and sign a written informed consent.

Exclusion Criteria:

1. Those who have a history of two or more spontaneous abortions (excluding biochemical pregnancy abortion) or three or more previous transplantations without achieving clinical pregnancy;

2. Those who have premature ovarian failure or ovarian gonadotropin resistance syndrome;

3. Those who have untreated uterine malformation or abnormality: double uterus, septate uterus (complete or incomplete);

4. Those who have untreated unilateral or bilateral hydrosalpinx;

5. Those who have uncured endometrial diseases (such as endometritis, endometrial polyps, endometriosis), adenomyosis, intrauterine adhesions, etc., and those with uterine fibroids of more than 4 cm;

6. Those who have endocrine diseases such as polycystic ovary syndrome, hyperprolactinemia, hyperandrogenism, hypothyroidism, abnormal adrenal function, etc., which affect ovulation;

7. Infertile patients with abnormal ovarian function caused by immunological factors, genetic factors or congenital physiological defects;

8. Those who have received pelvic radiotherapy;

9. Those who are known or suspected of having sex hormone-related malignant tumors;

10. Those who are allergic or intolerable to the medications involved in the study;

11. Those with contraindications to assisted reproductive technology or pregnancy, such as uncontrolled abnormal liver and renal function, diabetes, hypertension, thyroid disease, symptomatic heart disease, moderate to severe anemia, history of malignant tumor or history of thromboembolism or thrombosis formation tendency, serious mental illness, acute infection of urogenital system, sexually transmitted disease, extremely bad habits such as drug use, exposure to teratogenic radiation, poison, drugs (such as prednisone and other hormones, epinephrine, antibiotics, antihypertensive drugs, cardiovascular and cerebrovascular drugs, antiviral drugs) and are still under the effect of the drugs; and those whose uterus is unable to perform the function of pregnancy or who are intolerant of pregnancy due to physical diseases during pregnancy;

12. Those who have taken other TCMs or proprietary Chinese medicines that can invigorate the kidney or affect the evaluation of drug efficacy in the past 30 days;

13. Other patients who are deemed unsuitable to participate in this study by the researchers;

14. Those who are participating in other clinical trials;

15. Those who do not agree to participate in this study or do not sign the informed consent form.