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临床试验/NCT03575494
NCT03575494撤回不适用

Oral Health Status and Unexplained Female Infertility

Recep Tayyip Erdogan University Training and Research Hospital1 个研究点 分布在 1 个国家开始时间: 2018年4月15日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
试验地点
1
主要终点
female infertility

研究概览

简要总结

Periodontal diseases and dental caries are initiated by a pathogenic biofilm, in a susceptible host, affecting the tooth periodontium and hard tissues. Its possible association with many biologic systems has been studied. In this study, researchers investigated association between oral health and female infertility, and what is the biological rationale for such relationship.

详细描述

Power analysis was performed with the G-Power software package to determine sample size.

To cover possible data loss, 10% of a group were added to each group. Medical and dental examination will be performed both of control and experimental groups. In dental examination decayed, missing, or filled teeth (DMFT) index will be used according to World Health Organization (WHO 1997) criteria. All teeth were visually using the International Caries Detection and Assessment System (ICDAS-II).

To analyze the correlation between oral health status and female infertility linear regression test and for comparison of both the groups (case and control), two sample t test and chi square test were used.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women who had regular menses and can't conceive despite a long-term regular sexual intercourse for more than 12 months
  • Women with normal hormone values and uterine cavity with at least one healthy fallopian tube.
  • All male partners have a semen specimen with minimum 5 million motile sperm in the ejaculate.
  • The control group members have minimum two normal pregnancies

排除标准

  • Patients who have history of f; hydrosalpinx, polycystic ovarian syndrome, endometriosis grade 3-4, thyroid disease, tubal surgery, hyperprolactinemia, autoimmune diseases, diabetes mellitus, uterine/cervical anomalies, active liver disease, cardiovascular disease, premature ovarian failure, smoking and alcohol consumption, poor socioeconomic level, HIV-infected, obesity (body mass index ≥ 30 kg/m2), chronic upper respiratory tract diseases and dental fluorosis.
  • Patients using fluoride supplements and orthodontic appliances

结局指标

主要结局

female infertility

时间窗: 12 months

Women with normal hormone values and uterine cavity with at least one healthy fallopian tube. All male partners have a semen specimen with minimum 5 million motile sperm in the ejaculate.

次要结局

  • dental examination(1 Day)

研究者

发起方
Recep Tayyip Erdogan University Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gul Yildiz Telatar

Recep Tayyip Erdogan University Faculty of Dentistry

Recep Tayyip Erdogan University Training and Research Hospital

研究点 (1)

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