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Future fertility preservation strategies for patients with ovarian endometrioma undergoing laparoscopic cystectomy: Cryopreservation, activation and autografting of ovarian tissues.

Future fertility preservation strategies for patients with ovarian endometrioma undergoing laparoscopic cystectomy: Cryopreservation, activation and autografting of ovarian tissues. - Future fertility preservation strategies for patients with ovarian endometrioma undergoing laparoscopic cystectomy.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000038075
Enrollment
200
Registered
2019-10-01
Start date
2019-10-01
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

Ovarian endometrioma

Interventions

Laparoscopic cystectomy, ovarian tissue cryopreservation, and autografting at the desire for pregnancy. 1. Part of unilateral or bilateral normal ovarian tissue are harvested when performing laparosc

Sponsors

Department of Obstetrics and Gynecology, Juntendo University Faculty of Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Reproductive age women who is 20 years old or older at the acquision of agreement. 2. Ovarian endometrioma larger than 4cm diameter. 3. Women having desire for future pregnancy. 4. Women who give their voluntary informed consent after receiving the enough explanation and understanding about the participation for this study.

Exclusion criteria

Exclusion criteria: 1. Women under 20 years old or over reproductive age. 2. Women who does not have desire for future pregnancy. 3. Women with ovarian cancer. 4. Women who have some risk to undergo laparoscopic surgery by their fundamental disorders. 5. Women who are considered as inadequate for participating this study by lead principal investigator.

Design outcomes

Primary

MeasureTime frame
Primary outcomes are to compare the postoperative pregnancy rate and birthrate between the cases with or without ovarian tissue cryopreservation when performing laparoscopic cystectomy for ovarian endometrioma.

Secondary

MeasureTime frame
1.Basic information: age, medical history, diameter of the ovarian cyst, unilateral/bilateral lesion, preoperative hormone therapy, serum hormone level (E2, P4, FSH, LH, AMH, inhibin B), tumor marker level (C125, CA19-9). 2.Initial surgical findings (Laparoscopic cystectomy, partial resection and cryopreservation of ovarian tissue): operative duration, blood loss, weight of excised cyst, pathological findings, tumor diameter, unilateral/bilateral lesion, revised American Society of Reproductive Medicine (rASRM) score, obtained site of ovarian tissue for cryopreservation (distance from ovarian hilum and endometriosis lesion). 3. Clinical course from initial surgery to second surgery (In vitro activation and laparoscopic autografting of ovarian tissue): age trying to conceive, prophylactic hormone therapy, endometrioma recurrence, serum hormone level (E2, P4, FSH, LH, AMH), protocol used and outcomes of infertility treatment. 4. Second surgical findings: operative duration, blood loss, endometrioma recurrence, rASRM score, number of autografting ovarian tissue pieces, autografting site of ovarian tissue. Using part of the ovarian tissue, we measure a variety of molecular markers to evaluate the efficacy of Hippo signaling suppression, and we perform ultrasound/ Far infrared ray scanning and histological examination (follicle count, fibrotic evaluation, and inflammatory change) to evaluate the effect of IVA and the presence of residual follicles. We measure the serum angiogenesis factors to evaluate the angiogenic response of autografting ovarian tissue. 5. Clinical course after laparoscopic autografting of ovarian tissue: We measure vesicular ovarian follicle count and serum hormone level (E2, P4, FSH, LH, AMH). We record infertility treatment outcomes including number of oocytes retrieved, percentage of mature oocytes, fertility rate, acquisition rate of good-morphology embryos, cycle cancellation rate, pregnancy rate, birthrate and miscarriage rate.

Countries

Japan

Contacts

Public ContactKeisuke Murakami

Juntendo University Faculty of Medicine Obstetrics and Gynecology

kmuraka@juntendo.ac.jp03-3813-3111

Outcome results

None listed

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