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临床试验/NCT04686227
NCT04686227尚未招募不适用

Prevalence of Uterine Malformations in Newly Married Unselected Population

Hacettepe University1 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2023年1月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
3,000
试验地点
1
主要终点
spontaneous fecundability

研究概览

简要总结

Uterine malformation is occur due to the abnormal development of Mullerian canal during embryogenesis and it is known that it reduces the fertility and live birth rate and also increases the abortion and preterm birth rate. There are different classification methods have been used for defining the uterine malformations. The most common used classification method in the World is American Society of Reproductive Medicine (ASRM)'s system. In addition European Society of Human Reproduction and Embryology (ESHRE) and European Society for Gynaecological Endoscopy (ESGE) developed a new classification system. ASRM Uterine malformation Classification which is used for diagnosis and treatment of uterine malformations in our clinic is subdivided into 7 titles:

  1. Agenesis or Hypoplasia -(a. Vaginal b. Cervical c. Fundal d. Tubal e. Combine)
  2. Unicornuate -(a. Communicating Horn b. Non-Communicating Horn c. No Cavity d. No Horn)
  3. Uterus Didelphus
  4. Bicornuate Uterus-(a. Complete b. Partial)
  5. Uterine Septum- (a. Complete b. Partial)
  6. Arcuate Uterus
  7. Diethylstilboestrol (DES) Related

The diagnosis of some of the uterine malformations have been done by using two dimensional (2D) ultrasonography, hysterosalphingography or surgically (laparoscopy or laparotomy) traditionally. A non-invasive procedure is required for the diagnosis of the uterine malformation, which is evaluating both the uterine contour and endometrial cavity.

In recent years frequently used three dimensional (3D) ultrasound is a non-invasive and quick diagnostic technique, and also it is sensitive as MRI. In hospital based case control studies, the frequency of uterine malformation was generally around 6%, while it was 8% in infertile patients and 12% in patients with abortion. However, there is a lack of prospective studies investigating the prevalence of uterine anomalies, fertility potential and effects on pregnancy outcomes in unselected patient groups in the literature. Therefore, at the high level evidence, there is no evidence that these anomalies affect fertility and pregnancy outcomes and should be corrected. In this study it was aimed to investigate the effects of uterine malformations on fecundability and pregnancy outcomes by evaluating the uterine morphology with 3D ultrasonography and calling for control purposes at the 1st and 2nd years of newly married women between the ages of 18-40.

详细描述

This study is designed as a prospective observational study. As it was mentioned above, it was aimed to investigate the effects of uterine malformations on fecundability and pregnancy outcomes by evaluating the uterine morphology with 3D ultrasonography and calling for control purposes at the 1st and 2nd years of newly married women between the ages of 18-40. Firstly a template flyer's designed to call the newly married women to our study. To be able to explain the study and call the participants officially, official permission's got from the municipal leading the wedding hall nearby the hospital (In Turkey, wedding halls are managed by the municipality covering their locations. As it's needed, the document can be added.). A scholarship student will explain the study and invite the couples. First and second year After the ultrasound, the participants will be called by phone to ask unprotected sex period; if conceived, outcomes of pregnancy (miscarriage, preterm birth, term birth, malpresentation etc.). Then the data will be worked on SPSS.

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

  • Husband is under 45 years old

排除标准

  • Azospermia
  • Women with Premature Ovarian Failure

结局指标

主要结局

spontaneous fecundability

时间窗: 1 year after inclusion of last participant

1 year fecundability rate in subgroup of malformations and normal uterus

comparing of infertility rates

时间窗: 1 year

comparing of infertility rates between normal uterus population and every subgroup of uterine malformations

Pregnancy outcomes

时间窗: During the pregnancy

Rate of miscarriage, preterm birth, and malpresentation

Prevalence of uterine malformations

时间窗: 1 year after inclusion of last participant

prevalence of uterine malformations in study population according to ASRM/ESHRE classifications

Live birth rate

时间窗: 1 year

Having a live birth in all subgroups of uterine malformations and normal uterus

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sezcan Mumusoglu

Associate Professor

Hacettepe University

研究点 (1)

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