Clinical trial NCT03575494: Relationship Between Oral Health Status and Unexplained Female Infertility in Turkish Population
Official title: Oral Health Status and Unexplained Female Infertility
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Dental Caries
Female Infertility
Lead sponsor: Recep Tayyip Erdogan University Training and Research Hospital
Sponsor class: OTHER
First posted: 2018-07-02
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients were aged from 18 to 35 years, 100 females

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.

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

Primary outcomes:
measure: female infertility
timeFrame: 12 months
Secondary outcomes:
measure: dental examination
timeFrame: 1 Day
Other outcomes:
Locations:
city: Rize
country: Turkey
facility: Recep Tayyip Erdogan University
Study officials:
affiliation: Recep Tayyip Erdogan University Dentistry Faculty
name: Gül Yıldız Telatar
role: PRINCIPAL_INVESTIGATOR
References:
citation: Khanna SS, Dhaimade PA, Malhotra S. Oral Health Status and Fertility Treatment Including IVF. J Obstet Gynaecol India. 2017 Dec;67(6):400-404. doi: 10.1007/s13224-017-1025-0. Epub 2017 Jun 20.