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Prevalence of Uterine Malformations in Newly Married Unselected Population

Prevalence of Uterine Malformations in Newly Married Unselected Population

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04686227
Enrollment
3000
Registered
2020-12-28
Start date
2023-01-31
Completion date
2024-12-31
Last updated
2022-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility

Keywords

Uterine Malformations, Fertility, Infertility, Pregnancy, Miscarriage

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.

Interventions

DIAGNOSTIC_TEST3D Ultrasound

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

Sponsors

Hacettepe University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

* Husband is under 45 years old

Exclusion criteria

* Azospermia * Women with Premature Ovarian Failure

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of uterine malformations1 year after inclusion of last participantprevalence of uterine malformations in study population according to ASRM/ESHRE classifications
spontaneous fecundability1 year after inclusion of last participant1 year fecundability rate in subgroup of malformations and normal uterus
Pregnancy outcomesDuring the pregnancyRate of miscarriage, preterm birth, and malpresentation
Live birth rate1 yearHaving a live birth in all subgroups of uterine malformations and normal uterus
comparing of infertility rates1 yearcomparing of infertility rates between normal uterus population and every subgroup of uterine malformations

Countries

Turkey (Türkiye)

Contacts

Primary ContactSezcan Mumusoglu, Assoc. Prof.
sezcanmumusoglu@gmail.com+905326404673

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026