Prevalence of Uterine Malformations in Newly Married Unselected Population

NCT ID: NCT04686227

Last Updated: 2022-03-17

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 3000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-01-31
• Study Completion Date: 2024-12-31

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.

Conditions

Infertility

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Group-1, women with normal uterus

3D Ultrasound

Intervention Type: DIAGNOSTIC_TEST

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

3D Ultrasound

Intervention Type: DIAGNOSTIC_TEST

Newly married women between the ages of 18-40 will be evaluated by 3D ultrasonography about the uterine morphology

Interventions

3D Ultrasound

Newly married women between the ages of 18-40 will be evaluated by 3D ultrasonography about the uterine morphology

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Husband is under 45 years old

Exclusion Criteria

• Azospermia
• Women with Premature Ovarian Failure

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Hacettepe University

OTHER

Sponsor Role: lead

Responsible Party

Sezcan Mumusoglu

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sezcan Mumusoglu, Assoc. Prof.

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University

Locations

Hacettepe UniversityHacettepe University School of Medicine, Department of Ob/Gyn

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Central Contacts

Sezcan Mumusoglu, Assoc. Prof.

Role: CONTACT

sezcanmumusoglu@gmail.com

+905326404673

Facility Contacts

Sezcan Mumusoglu, Assoc. Prof.

Role: primary

sezcanmumusoglu@gmail.com

+905326404673

References

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.

Reference Type: BACKGROUND

PMID: 21830244 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9402295 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17495638 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17182166 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25690307 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27235766 (View on PubMed)

Other Identifiers

HU3643

Identifier Type: -

Identifier Source: org_study_id