Prevalence of Uterine Malformations in Newly Married Unselected Population

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Infertility
• Intervention / Treatment: Diagnostic test: 3D Ultrasound

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.

• Study Type: Observational
• Enrollment (Anticipated): 3000

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06100
    • Hacettepe UniversityHacettepe University School of Medicine, Department of Ob/Gyn
    • Sub-Investigator: Ali Can Gunes, MD
    • Sub-Investigator: Ruya Tez, MD
    • Sub-Investigator: Nuseybe Artiran, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Newly married women between the ages of 18-40

Description

Inclusion Criteria:

• Husband is under 45 years old

Exclusion Criteria:

• Azospermia
• Women with Premature Ovarian Failure

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hacettepe University

Publications and helpful links

General Publications

• Chan YY, Jayaprakasan K, Tan A, Thornton JG, Coomarasamy A, Raine-Fenning NJ. Reproductive outcomes in women with congenital uterine anomalies: a systematic review. Ultrasound Obstet Gynecol. 2011 Oct;38(4):371-82. doi: 10.1002/uog.10056.
• Raga F, Bauset C, Remohi J, Bonilla-Musoles F, Simon C, Pellicer A. Reproductive impact of congenital Mullerian anomalies. Hum Reprod. 1997 Oct;12(10):2277-81. doi: 10.1093/humrep/12.10.2277.
• Rackow BW, Arici A. Reproductive performance of women with mullerian anomalies. Curr Opin Obstet Gynecol. 2007 Jun;19(3):229-37. doi: 10.1097/GCO.0b013e32814b0649.
• Tomazevic T, Ban-Frangez H, Ribic-Pucelj M, Premru-Srsen T, Verdenik I. Small uterine septum is an important risk variable for preterm birth. Eur J Obstet Gynecol Reprod Biol. 2007 Dec;135(2):154-7. doi: 10.1016/j.ejogrb.2006.12.001. Epub 2006 Dec 19.
• Graupera B, Pascual MA, Hereter L, Browne JL, Ubeda B, Rodriguez I, Pedrero C. Accuracy of three-dimensional ultrasound compared with magnetic resonance imaging in diagnosis of Mullerian duct anomalies using ESHRE-ESGE consensus on the classification of congenital anomalies of the female genital tract. Ultrasound Obstet Gynecol. 2015 Nov;46(5):616-22. doi: 10.1002/uog.14825. Epub 2015 Oct 5.
• Practice Committee of the American Society for Reproductive Medicine. Electronic address: ASRM@asrm.org; Practice Committee of the American Society for Reproductive Medicine. Uterine septum: a guideline. Fertil Steril. 2016 Sep 1;106(3):530-40. doi: 10.1016/j.fertnstert.2016.05.014. Epub 2016 May 25.

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2023
• Primary Completion (Anticipated): January 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: December 18, 2020
• First Submitted That Met QC Criteria: December 24, 2020
• First Posted (Actual): December 28, 2020

Study Record Updates

• Last Update Posted (Actual): March 17, 2022
• Last Update Submitted That Met QC Criteria: March 15, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Infertility; Pregnancy; Miscarriage; Fertility; Uterine Malformations
• Additional Relevant MeSH Terms: Infertility; Congenital Abnormalities
• Other Study ID Numbers: HU3643

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No