Efficacy of Traditional Chinese Medicine on Ameliorating IVF-ET Outcomes of Diminished Ovarian Re… (NCT05577455) | Clinical Trial Compass
UnknownPhase 3
Efficacy of Traditional Chinese Medicine on Ameliorating IVF-ET Outcomes of Diminished Ovarian Reserve Patients
266 participantsStarted 2022-11-10
Plain-language 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.
Who can participate
Age range20 Years – 42 Years
SexFEMALE
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Inclusion criteria
✓. Female, 20 years old ≤ age ≤ 42 years old;
✓. The menstrual cycle is generally regular; 21 days \< menstrual cycle \< 35 days;
✓. Those who meet the diagnostic criteria for DOR in Western medicine;
✓. Those who meet the TCM differential criteria of kidney deficiency syndrome;
✓. Those who are scheduled to undergo IVF-ET;
✓. Those who voluntarily participate in this clinical trial and sign a written informed consent.
Exclusion criteria
✕. 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;
✕. Those who have premature ovarian failure or ovarian gonadotropin resistance syndrome;
✕. Those who have untreated uterine malformation or abnormality: double uterus, septate uterus (complete or incomplete);
✕. Those who have untreated unilateral or bilateral hydrosalpinx;
✕. 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;
✕. Those who have endocrine diseases such as polycystic ovary syndrome, hyperprolactinemia, hyperandrogenism, hypothyroidism, abnormal adrenal function, etc., which affect ovulation;