Mar. 29, 2019 |
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Sept. 30, 2022 |
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jRCTs041180140 |
The evaluation for usefulness of dienogest to prevent decline of ovarian reserve by cystectomy for endometriomas. (The evaluation for usefulness of dienogest to prevent decline of ovarian reserve by cystectomy for endometriomas.) |
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The evaluation for usefulness of dienogest to prevent decline of ovarian reserve by cystectomy for endometriomas (The evaluation for usefulness of dienogest to prevent decline of ovarian reserve by cystectomy for endometriomas) |
June. 22, 2020 |
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57 |
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The mean age was 33 years, all female, 25 patients in the GnRH group and 32 patients in the DNG group were assigned. The median size of the endometriosis was 7 cm (5-8 cm) with no significant difference between the two groups. |
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The pace of enrollment was about as expected compared to the pace initially predicted. In the GnRHa group, 3 patients dropped out due to allergies, and in the DNG group, 2 patients did not consent to blood sampling, 1 patient was below the AMH threshold, 1 patient had emergency surgery, and 1 patient was not eligible for the study. The final analysis was 22 patients in the GnRHa group and 27 patients in the DNG group. |
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Allergies for GnRH antagonist treatment. |
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In this study, the efficacy of DNG was the primary endpoint, and AMH was evaluated as an index of ovarian reserve. The results showed that the DNG group had a higher percentage of AMH levels at 1 year postoperatively than the GnRHa group, indicating efficacy (two-tailed Student's t-test). As secondary endpoints, we evaluated the relationship between serum FSH level, surgical findings: operative time, blood loss, and endometriosis severity (rASRM score), and found that there was generally no difference between the two groups, but there was a significant difference in serum FSH level at 2 months postoperatively (Mann-Whitney U test). |
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Our data revealed that DNG is more effective than GnRHa in preserving ovarian reserve after cystectomy of ovarian endometrioma. This is achieved through the reduction of the inflammatory response during the perioperative period and other endometriosis-related inflammatory reactions. |
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Sept. 30, 2022 |
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Dec. 06, 2021 |
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https://rbej.biomedcentral.com/articles/10.1186/s12958-021-00866-2 |
No |
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Non |
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https://jrct.niph.go.jp/latest-detail/jRCTs041180140 |
Osuka Satoko |
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Nagoya University Hospital |
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65 Tsurumai-cho, Showa-ku, Nagoya |
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+81-52-744-2261 |
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satokoosuka@med.nagoya-u.ac.jp |
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Osuka Satoko |
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Nagoya University Hospital |
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65 Tsurumai-cho, Showa-ku, Nagoya |
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+81-52-744-2261 |
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satokoosuka@med.nagoya-u.ac.jp |
Complete |
June. 01, 2016 |
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June. 14, 2016 | ||
60 | ||
Interventional |
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randomized controlled trial |
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open(masking not used) |
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active control |
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single assignment |
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treatment purpose |
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20-42 years old women with semi- or bi- lateral ovarian endometrioma more than 4cm diameter. |
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history of hormonal treatment, ovarian operation, malignant tumor, polycystic ovarian syndorome |
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20age old over | ||
42age old under | ||
Female |
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Health Condition(s) or Problem(s) Studied Ovarian endometrial cyst |
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Administration of dienogest or buserelin |
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Comparison of serum AMH levels |
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Serum FSH levels, pregnancy rate, findings of ultrasonography |
Contact Mochida Pharmaceutical Co., Ltd. | |
Not applicable |
Nagoya University Ethical Review Board | |
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi | |
+81-52-744-2479 |
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ethics@med.nagoya-u.ac.jp | |
Approval | |
Mar. 13, 2019 |
UMIN-CTR000033605 | |
none |