A prospective, randomized study to examine whether administration of plant extract improves outcomes of assisted reproductive technology (ART) therapy

INTERVENTION: ART patients who meet inclusion criteria and do not meet exclusion criteria are prospectively allocated at random into two groups as follows; the control group who undergoes ART therapy without administration of plant extract, and the plant‐extract group who undergoes ART therapy after one to two months of administration of plant extract. And the outcomes of ART are compared between two groups. In the plant‐extract group, patients begins daily administration (once just before breakfast) of plant extract, 100 mg (Hayashikane Sangyou Co.,Ltd) on the menstrual cycle day 2‐4 after they receive various clinical examinations as follows; glucometabolism ex. (oral glucose tolerance test, C‐peptide, Hb A1c, glycoalbumin, general chemistry, etc.), hormones (FSH, LH, E2, PRL, AMH, T, DHEA‐S, etc.), measurements of blood advanced glycation end‐products (AGEs), and skin test (Cutometer ex., questionnaire on skin conditions, etc.). After 1‐2 months of administration of plant extract, they repeat the same examinations and then undergo ART therapy. Follicular fluid are collected at oocyte retrieval and AGEs in the fluid are measured. Patients can freely decide to participate in the trial or not, and do not have any disadvantages when they do not participate. Informed consents are obtained from all participants after they have received appropriate explanations about implications, purposes, methods, expected benefits, and possible risks of plant extract administration, and the protection of privacy. The control group undergoes ART therapy without administration of plant extract. The same examinations as described above in the plant‐extract group are received on cycle day 2‐4 before 1‐2 months of and just before ART therapy. AGEs in follicular fluid are also measured. CONDITION: Infertility of high age treated by assisted reproductive technology (ART) therapy. PRIMARY OUTCOME: The number of superior embryos. SECONDARY OUTCOME: Follicular growth, the numbers of retrieved oocytes, fertilized oocytes and embryos, pregnancy rates, and the changes in various metabolic and hormonal examinations. INCLUSION CRITERIA: The study includes patients who satisfy all the following criteria; (1) 38‐42 years of age, (2) to undergo the first, second or third attempt of assisted reproductive technology (ART) therapy, (3) no medication to affect the glucometabolism is nor has been administered.