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Mar. 29, 2019

Sept. 30, 2022

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.)

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

57

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.

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.

Allergies for GnRH antagonist treatment.

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).

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.

Sept. 30, 2022

Dec. 06, 2021

https://rbej.biomedcentral.com/articles/10.1186/s12958-021-00866-2

No

Non

https://jrct.niph.go.jp/latest-detail/jRCTs041180140

Osuka Satoko

Nagoya University Hospital

65 Tsurumai-cho, Showa-ku, Nagoya

+81-52-744-2261

satokoosuka@med.nagoya-u.ac.jp

Osuka Satoko

Nagoya University Hospital

65 Tsurumai-cho, Showa-ku, Nagoya

+81-52-744-2261

satokoosuka@med.nagoya-u.ac.jp

Complete

June. 01, 2016

June. 14, 2016
60

Interventional

randomized controlled trial

open(masking not used)

active control

single assignment

treatment purpose

20-42 years old women with semi- or bi- lateral ovarian endometrioma more than 4cm diameter.

history of hormonal treatment, ovarian operation, malignant tumor, polycystic ovarian syndorome

20age old over
42age old under

Female

Health Condition(s) or Problem(s) Studied Ovarian endometrial cyst

Administration of dienogest or buserelin

Comparison of serum AMH levels

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

ethics@med.nagoya-u.ac.jp
Approval

UMIN-CTR000033605

none

History of Changes

No Publication date
5 Sept. 30, 2022 (this page) Changes
4 Aug. 12, 2021 Detail Changes
3 Oct. 19, 2020 Detail Changes
2 Aug. 15, 2019 Detail Changes
1 Mar. 29, 2019 Detail