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Cryopreservation, activation and autografting of ovarian tissues for infertility treatment in patients with primary ovarian in sufficiency (POI)

Cryopreservation, activation and autografting of ovarian tissues for infertility treatment in patients with primary ovarian in sufficiency (POI) - Infertility treatment for patients with primary ovarian insufficiency (POI)

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000034464
Enrollment
500
Registered
2018-10-12
Start date
2018-10-12
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

POI patients with a chief complaint of infertility. Patients who are predicted to become POI.

Interventions

IVA 1.We measure serum molecular markers before surgeries to evaluate the effect of hippo signal inhibition and presence of residual follicles. 2.Whole or part of one ovary is removed under laparo
pouch. 6.We treat patients with estrogen for 2 weeks before autografting. After grafting, hCG is administered to induce production of angiogenesis factor to help vascularization and survival of gr

Sponsors

International University of Health and Welfare School of Medicine Department of Obstetrics and Gynecology
Lead Sponsor
Sanno Hospital / Stanford University
Collaborator

Eligibility

Sex/Gender
Female

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

MeasureTime frame
Comparison of follicle growth rates after IVA (in vitro activation) treatment with those of base line numbers.

Secondary

MeasureTime 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

Public ContactKazuhiro Kawamura

International University Health and Welfare School of Medicine Department of Obstetrics and Gynecology

kazuhironanami@gmail.com0476-20-7701

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026