Hysteroscopic Metroplasty in Unexplained Infertile Women With Dysmorphic Uterus

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Brief Title

Hysteroscopic Metroplasty in Unexplained Infertile Women With Dysmorphic Uterus

Official Title

The Comparison of Reproductive Outcomes of Hsyteroscopic Metroplasty Versus Spontaneous Coitus Plus COH/IUI Cycles in Unexplained Infertile Women With Dysmorphic Uterus

Brief Summary

      The correlation between dysmorphic uterus and infertility still remains enigmatic. We aim to
      evaluate the reproductive outcomes of metroplasty via office hysteroscopy in unexplained
      infertile women with dysmorphic uterus with comparing a group of unexplained infertile women
      performing 6 months spontaneous cycles plus 3 cycles controlled ovarian hyperstimulation and
      intrauterine insemination by randomized trial.
    

Detailed Description

      A dysmorphic uterus is a second-class (Class U1) uterine anomaly in the The European Society
      of Human Reproduction and Embryology (ESHRE) and the European Society for Gynaecological
      Endoscopy (ESGE) (ESHRE/ESGE) consensus on the classification of congenital genital tract
      anomalies, which was formerly known as "T-shaped uterus" in the American Fertility Society
      (AFS) Classification of Anomalies of the Müllerian Duct that leads to poor reproductive and
      obstetric outcomes.

      The reproductive performance of dysmorphic uterus is not well-known issue. We designed a
      randomized trial in unexplained infertile couples women with dysmorphic uterus. After
      allocation of properly selected women, hysteroscopy group will be undertaken metroplasty
      procedure and 9 months follow-up period with natural conception. Second group will be
      undertaken to six months spontaneous coitus and three cycles clomiphene citrate and
      intrauterine insemination cycles. After nine months of follow-up of both groups, the
      pregnancy and reproductive outcomes will be evaluated.
    


Study Type

Interventional


Primary Outcome

clinical pregnancy rate (CPR)

Secondary Outcome

 abortion

Condition

Hysteroscopy

Intervention

office hysteroscopic metroplasty intervention arm

Study Arms / Comparison Groups

 Intervention arm: Hysterocopy group
Description:  Office hyteroscopic metroplasty will be performed. After oparetion 9 months spontaneous conception Intervention arm for hysteroscopy group

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

86

Start Date

June 8, 2018

Completion Date

December 30, 2020

Primary Completion Date

December 31, 2019

Eligibility Criteria

        Inclusion Criteria:

        Unexplained infertile couples with;

          1. Dysmorpic uterus in hysterosalpingography

          2. Normal spermiogram

        2. Bilateral patent tubes in hysterosalpingography 3. Normal ovarian reserve (AMH >1.5
        ng/dl and/or total bilateral antral follicle count >8)

        Exclusion Criteria:

          1. Women with history of pelvic surgery including endometriosis and/or tubal surgery

          2. women with endometrioma which was visualised/suspected on transvaginal ultrasonography

          3. Women with anovulation

          4. Women with diminished ovarian reserve (AMH < 1.5 ng/dl and/or total bilateral antral
             follicle count <8)

          5. Couples with abnormal spermiogram parameters (oligospermia, oligoasthenospermia,
             oligoasthenoteratozoospermia, azospermia)

          6. Women with alive children

          7. Obese women (BMI>30 kg/m2)
      

Gender

Female

Ages

20 Years - 35 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Bulent Haydardedeoglu, Assoc.Prof., , 

Location Countries

Turkey

Location Countries

Turkey

Administrative Informations


NCT ID

NCT03579550

Organization ID

KA17/151


Responsible Party

Sponsor-Investigator

Study Sponsor

Bulent Haydardedeoglu


Study Sponsor

Bulent Haydardedeoglu, Assoc.Prof., Principal Investigator, Baskent University


Verification Date

March 2019