Prevalence of Uterine Malformations in Newly Married Unselected Population

Infertility Clinical Trial

Official title:

Prevalence of Uterine Malformations in Newly Married Unselected Population

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04686227
• Other study ID #: HU3643
• Status: Not yet recruiting
• Start date: January 2023
• Est. completion date: December 2024

Study information

• Verified date: March 2022
• Source: Hacettepe University
• Contact: Sezcan Mumusoglu, Assoc. Prof.
• Phone: +905326404673
• Email: sezcanmumusoglu[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 3000
• Est. completion date: December 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Husband is under 45 years old

Exclusion Criteria:

• Azospermia

• Women with Premature Ovarian Failure

Related Conditions & MeSH terms

• Congenital Abnormalities
• Infertility

Intervention

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

Locations

Country	Name	City	State
Turkey	Hacettepe UniversityHacettepe University School of Medicine, Department of Ob/Gyn	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

References & Publications (6)

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. Review. — View Citation

Graupera B, Pascual MA, Hereter L, Browne JL, Úbeda B, Rodríguez I, Pedrero C. Accuracy of three-dimensional ultrasound compared with magnetic resonance imaging in diagnosis of Müllerian 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. — View Citation

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. Review. — View Citation

Rackow BW, Arici A. Reproductive performance of women with müllerian anomalies. Curr Opin Obstet Gynecol. 2007 Jun;19(3):229-37. Review. — View Citation

Raga F, Bauset C, Remohi J, Bonilla-Musoles F, Simón C, Pellicer A. Reproductive impact of congenital Müllerian anomalies. Hum Reprod. 1997 Oct;12(10):2277-81. — View Citation

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. Epub 2006 Dec 19. — View Citation

Outcome

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