Prevalence of Uterine Malformations in Newly Married Unselected Population

Not yet recruiting

• Conditions: Infertility
• Interventions: Diagnostic Test: 3D Ultrasound

• Registration Number: NCT04686227
• Lead Sponsor: Hacettepe University

Brief Summary

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.

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-12-18
• Study First Submitted QC: 2020-12-24
• Study First Posted: 2020-12-28
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-15
• Last Update Posted: 2022-03-17
• Study Start: 2023-01
• Primary Completion: 2024-01
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 3000

Inclusion Criteria

• Husband is under 45 years old

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Exclusion Criteria

• Azospermia
• Women with Premature Ovarian Failure

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group-1, women with normal uterus	3D Ultrasound	-
Group-2, women with any uterine malformations	3D Ultrasound	Group-2 is going to be sub-grouped according to ASRM and ESHRE classifications

Primary Outcome Measures

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

Trial Locations

Locations (1)

Hacettepe UniversityHacettepe University School of Medicine, Department of Ob/Gyn; 🇹🇷 Ankara, Turkey