Prevalence of Uterine Malformations in Newly Married Unselected Population

NCT04686227 | Unknown DMC

• 1 other identifier: HU3643
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

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. 1.Agenesis or Hypoplasia -(a. Vaginal b. Cervical c. Fundal d. Tubal e. Combine)
2. 2.Unicornuate -(a. Communicating Horn b. Non-Communicating Horn c. No Cavity d. No Horn)
3. 3.Uterus Didelphus
4. 4.Bicornuate Uterus-(a. Complete b. Partial)
5. 5.Uterine Septum- (a. Complete b. Partial)
6. 6.Arcuate Uterus
7. 7.Diethylstilboestrol (DES) Related

Conditions

Infertility

Keywords

Uterine Malformations; Fertility; Infertility; Pregnancy; Miscarriage

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

Group-1, women with normal uterus

Diagnostic Test: 3D Ultrasound

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

Interventions

3D Ultrasound DIAGNOSTIC_TEST

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

Group-1, women with normal uterus; Group-2, women with any uterine malformations

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Newly married women between the ages of 18-40

You may qualify if:

• Husband is under 45 years old

You may not qualify if:

• Azospermia
• Women with Premature Ovarian Failure

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

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

Ankara, 06100, Turkey (Türkiye)

Location

Related 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.

  PMID: 21830244 BACKGROUND

• 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.

  PMID: 9402295 BACKGROUND

• 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.

  PMID: 17495638 BACKGROUND

• 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.

  PMID: 17182166 BACKGROUND

• 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.

  PMID: 25690307 BACKGROUND

• 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.

  PMID: 27235766 BACKGROUND

MeSH Terms

Conditions

Infertility; Uterine Anomalies; Abortion, Spontaneous

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications

Study Officials

• Sezcan Mumusoglu, Assoc. Prof.

  Hacettepe University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sezcan Mumusoglu, Assoc. Prof.

CONTACT

+905326404673; sezcanmumusoglu@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 18, 2020
• First Posted: December 28, 2020
• Study Start: January 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 17, 2022

Record last verified: 2022-03

Locations

TU (1)