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临床试验/NCT03620838
NCT03620838Unknown不适用

Endometrioma Per se Versus Treatment Related Reduction in Ovarian Reserve (ERROR-2 Trial)

Uludag University1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2019年3月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
250
试验地点
1
主要终点
AMH

研究概览

简要总结

The present multi-center study aimed to evaluate whether endometrioma-associated decline in ovarian reserve is progressive in the absence of an intervention and is greater in magnitude than the natural decline over time. Also the affect of endometrioma treatment modalities like surgery or medical on the ovarian reserve over time.

详细描述

While there is now a proven, prominent relationship between endometriosis and infertility, the exact mechanism of this relationship is still unclear. The relationship between endometriosis and infertility has been increasingly investigated in recent years. Infertility can be explained in those patients with advanced disease, which causes disturbance of the pelvic anatomy and will also prevent tubal passage, but the mechanism at the early stage of endometriosis has not yet been elucidated.

It has been shown that patients with endometriomas have low quantitative ovarian-reserve tests. It has also been shown with oocyte donation studies that endometriosis may be accompanied by a quantitative decrease in oocyte quality defects which may further adversely affect existing ovarian reserves. There are still debates as to whether the presence of endometriomas and the availability of endometriomas itself reduces the over-reserve, but there is no objective study or data on the subject.There are a number of studies that endometriosis may negatively affect the reserve, and also that surgery may cause further damage to the ovarian reserve.There is still lack of definite data for the affect of endometriomas per se and endometriomas treatment modalities ( Oral contraceptive pills (OCP) / progesterone or surgery)on the ovarian reserve over time. For this reason the investigators aimed to evaluate whether endometrioma-associated decline in ovarian reserve is progressive in the absence of any intervention and is greater in magnitude than the natural decline over time. Also the affect of endometrioma treatment modalities like surgery or medical on the ovarian reserve over time.

The study is planned as a prospective study including women with endometrioma diagnosed with ultrasonography and also healthy age matched women without endometriomas as the control group. Endometrioma patients will be divided to 4 subgroups of patients. The first group will be comprised women with endometriomas that who will not require any medical or surgical intervention, the second subgroup will be comprised from endometrioma patients will be treated with OCP during the study period, the third one will be comprised from endometrioma patients will be treated with progesterone and the last subgroup will be comprised from endometrioma patients who will be treated with surgical excision of the cyst. All of the patients with and without endometrioma will be evaluated with ultrasonography for Antral Follicle Count (AFC) and blood samples will be taken during recruitment for Anti-müllerian Hormone (AMH) values. Additional assessments will be done after 3 and 6 months after the first assessment. All the results will be statistically compared within the groups.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women between 18 and 40 years of age
  • Who had at least one endometrioma >3 cm

排除标准

  • İrregular periods
  • Polycystic ovarian syndrome
  • Pregnant patients
  • Patients unable to give informed consent • Using medication which could affect ovarian function during six months before recruitment

研究组 & 干预措施

Group 2

Patients with endometrioma who had at least one endometrioma >3 cm and who will be treated with OCP during the study period

干预措施: oral contraceptive pill, oral progesterone (Drug)

Group 3

Patients with endometrioma who had at least one endometrioma >3 cm and who will be treated with oral progesterone during the study period

干预措施: oral contraceptive pill, oral progesterone (Drug)

Group 4

Patients with endometrioma who had at least one endometrioma >3 cm and who will be treated with surgery short after recruitment

干预措施: oral contraceptive pill, oral progesterone (Drug)

结局指标

主要结局

AMH

时间窗: 6 months

Change from baseline Anti müllerian hormone levels at 6 months

次要结局

  • AFC(6 months)

研究者

发起方
Uludag University
申办方类型
Other
责任方
Principal Investigator
主要研究者

GÜRKAN UNCU,PROF. MD

Principal Investigator ; Prof. Dr. Gürkan Uncu

Uludag University

研究点 (1)

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