Prevalence of Uterine Malformations in Newly Married Unselected Population

Study Overview
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Brief Summary
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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: Agenesis or Hypoplasia -(a. Vaginal b. Cervical c. Fundal d. Tubal e. Combine) Unicornuate -(a. Communicating Horn b. Non-Communicating Horn c. No Cavity d. No Horn) Uterus Didelphus Bicornuate Uterus-(a. Complete b. Partial) Uterine Septum- (a. Complete b. Partial) Arcuate Uterus 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.

Detailed Description
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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.

Official Title
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Prevalence of Uterine Malformations in Newly Married Unselected Population

Conditions
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Infertility

Intervention / Treatment
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* Diagnostic Test: 3D Ultrasound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Husband is under 45 years old Exclusion Criteria: Azospermia Women with Premature Ovarian Failure

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group-1, women with normal uterus<br> | Diagnostic Test: 3D Ultrasound<br>* Newly married women between the ages of 18-40 will be evaluated by 3D ultrasonography about the uterine morphology<br>|
| Group-2, women with any uterine malformations<br>Group-2 is going to be sub-grouped according to ASRM and ESHRE classifications | Diagnostic Test: 3D Ultrasound<br>* Newly married women between the ages of 18-40 will be evaluated by 3D ultrasonography about the uterine morphology<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of uterine malformations | prevalence of uterine malformations in study population according to ASRM/ESHRE classifications | 1 year after inclusion of last participant | 
| spontaneous fecundability | 1 year fecundability rate in subgroup of malformations and normal uterus | 1 year after inclusion of last participant | 
| Pregnancy outcomes | Rate of miscarriage, preterm birth, and malpresentation | During the pregnancy | 
| Live birth rate | Having a live birth in all subgroups of uterine malformations and normal uterus | 1 year | 
| comparing of infertility rates | comparing of infertility rates between normal uterus population and every subgroup of uterine malformations | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Uterine Malformations, Fertility, Infertility, Pregnancy, Miscarriage