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Clinical Trials/NCT03575494
NCT03575494
Withdrawn
N/A

Oral Health Status and Unexplained Female Infertility

Recep Tayyip Erdogan University Training and Research Hospital1 site in 1 countryApril 15, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Dental Caries
Sponsor
Recep Tayyip Erdogan University Training and Research Hospital
Locations
1
Primary Endpoint
female infertility
Status
Withdrawn
Last Updated
5 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
April 15, 2018
End Date
February 15, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Recep Tayyip Erdogan University Training and Research Hospital
Responsible Party
Principal Investigator
Principal Investigator

Gul Yildiz Telatar

Recep Tayyip Erdogan University Faculty of Dentistry

Recep Tayyip Erdogan University Training and Research Hospital

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

female infertility

Time Frame: 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.

Secondary Outcomes

  • dental examination(1 Day)

Study Sites (1)

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