Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Prevalence of Uterine Malformations in Newly Married Unselected Population

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04686227
Recruitment Status : Recruiting
First Posted : December 28, 2020
Last Update Posted : December 28, 2020
Sponsor:
Information provided by (Responsible Party):
Sezcan Mumusoglu, 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.


Condition or disease Intervention/treatment
Infertility 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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prevalence of Uterine Malformations in Newly Married Unselected Population
Estimated Study Start Date : January 2021
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility

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




Primary Outcome Measures :
  1. Prevalence of uterine malformations [ Time Frame: 1 year after inclusion of last participant ]
    prevalence of uterine malformations in study population according to ASRM/ESHRE classifications

  2. spontaneous fecundability [ Time Frame: 1 year after inclusion of last participant ]
    1 year fecundability rate in subgroup of malformations and normal uterus

  3. Pregnancy outcomes [ Time Frame: During the pregnancy ]
    Rate of miscarriage, preterm birth, and malpresentation

  4. Live birth rate [ Time Frame: 1 year ]
    Having a live birth in all subgroups of uterine malformations and normal uterus

  5. comparing of infertility rates [ Time Frame: 1 year ]
    comparing of infertility rates between normal uterus population and every subgroup of uterine malformations



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Newly married women between the ages of 18-40
Criteria

Inclusion Criteria:

  • Husband is under 45 years old

Exclusion Criteria:

  • Azospermia
  • Women with Premature Ovarian Failure

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04686227


Contacts
Layout table for location contacts
Contact: Sezcan Mumusoglu, Assoc. Prof. +905326404673 sezcanmumusoglu@gmail.com

Locations
Layout table for location information
Turkey
Hacettepe UniversityHacettepe University School of Medicine, Department of Ob/Gyn Recruiting
Ankara, Turkey, 06100
Contact: Sezcan Mumusoglu, Assoc. Prof.    +905326404673    sezcanmumusoglu@gmail.com   
Principal Investigator: Gurkan Bozdag, Prof.         
Principal Investigator: Sezcan Mumusoglu, Assoc. Prof.         
Sub-Investigator: Ali Can Gunes, MD         
Sub-Investigator: Ruya Tez, MD         
Sub-Investigator: Nuseybe Artiran, MD         
Sponsors and Collaborators
Hacettepe University
Investigators
Layout table for investigator information
Principal Investigator: Sezcan Mumusoglu, Assoc. Prof. Hacettepe University
Publications:
Layout table for additonal information
Responsible Party: Sezcan Mumusoglu, Associate Professor, Hacettepe University
ClinicalTrials.gov Identifier: NCT04686227    
Other Study ID Numbers: HU3643
First Posted: December 28, 2020    Key Record Dates
Last Update Posted: December 28, 2020
Last Verified: December 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sezcan Mumusoglu, Hacettepe University:
Uterine Malformations
Fertility
Infertility
Pregnancy
Miscarriage
Additional relevant MeSH terms:
Layout table for MeSH terms
Infertility
Congenital Abnormalities