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

Cryopreservation 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-UMIN000029807
Enrollment
200
Registered
2017-11-16
Start date
2017-08-01
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 laparosc
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 gra

Sponsors

Rose Ladies Clinic
Lead Sponsor
St. Marianna University / Stanford University
Collaborator

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria:

Exclusion criteria

Exclusion criteria: 1. Patients 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.

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 ContactEri Ozasa

Rose Ladies Clinic Department of information and research

eriozasa@roseladiesclinic.jp03-3703-0116

Outcome results

None listed

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