POI patients with a chief complaint of infertility. Patients who are predicted to become POI.
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. POI patients 2. IVF patients with severe poor responder who fulfill two out of three following criteria of ESHRE guideline (2011) 1) Over 40 years-old or patients with other risks for poor responder 2) Low responder diagnosed by a previous ovarian stimulation (less than 3 oocytes retrieval under sufficient ovarian stimulation) 3) Abnormal ovarian reserve (AFC:<5-7 or AMH: 0.5-1.1 ng/ml) 3. Reproductive age female patients over 20 years-old We enroll the patients of 1. or 2. who fulfill 3. criteria.
Exclusion criteria
Exclusion criteria: 1. Female patients younger than 20 years-old and over reproductive age 2. Patients with high risk for laparoscopy. 3. Patients without permission of pregnancy due to complications 4.Patients judged to be inappropriate for the study by the physicians. We exclude the patients who meet one of criteria 1. to 4.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of follicle growth rates after IVA (in vitro activation) treatment with those of base line numbers. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the presence of residual follicles, we measure the levels of serum biomarker for early follicles before ovariectomy. Using part of the ovarian tissue, we evaluate the conditions of the follicles and oocytes after thawing structurally and histologically. To evaluate the efficacy and presence of residual follicles, part of the ovarian tissues is used for cultivation, ultrasound/ Far infrared ray scanning and histological examination (follicle count, fibrotic evaluation, antithyroid antibody and inflammatory change) to evaluate the effect of IVA and the presence of residual follicles. To judge the effect of hCG on induction of angiogenetic factors production after autografting, we collect part of uterine endometrium before autografting and determine the expression levels of related genes and proteins in neovascularization. We further measure serum VEGF levels after hCG administration. In the case of very rare type of POI, Resistant Ovary Syndrome (ROS), we detect anti-FSH and FSHR antibodies, analyze their responsible genes and ovarian tissue structures, and measure serum levels of CCN growth factors after linear cutting of ovarian cortex. After IVA, we perform ovarian stimulation by hormonal therapy. Under evaluation of estradiol, progesterone, FSH, LH levels, we stimulate follicle growth for subsequent IVF. We compare the proportions of oocyte retrieval, oocyte maturation, fertilization, high-quality embryos, pregnancy and abortion with those of base line levels. | — |
Countries
Japan
Contacts
International University Health and Welfare School of Medicine Department of Obstetrics and Gynecology