Hysteroscopic Metroplasty in Unexplained Infertile Women With Dysmorphic Uterus

Learn more about:
Related Clinical Trial
Medical Treatment in Ectopic Tubal Pregnancy Evaluation of Different Doses of Letrozole in Ectopic Pregnancy Evaluation of Ipsilateral Tubal Patency After Conservative Medical or Surgical Treatment. Improving Mental Health Following Early PREgnancy Loss Using a Brief Cognitive Task Expectant Management of Ectopic Pregnancy Psychological Impact of Pregnancy of Unknown Location Assessment of Biomarkers in Pregnancy on Unknown Location and Ectopic Pregnancy Comparative Study on the Efficacy of Ovarian Stimulation Protocols on the Success Rate of ICSI in Female Infertility Hysteroscopic Metroplasty in Unexplained Infertile Women With Dysmorphic Uterus Cornual Wedge Resection Outcome Pregnancies of Uncertain Location or Viability Research Randomized Population-Based Study on Chlamydia Trachomatis Screening Sonographic Assessment and Visualization of Ectopics in Emergency Medicine Kisspeptin Levels in Early Pregnancy RCT for Women With a Persisting Pregnancy of Unknown Location Optimal Treatment for Women With a Persisting Pregnancy of Unknown Location Activin A and Inhibin A in Predicting Outcome of Pregnancies of Unknown Location After Assisted Reproductive Technology Evaluation of the Axonemal Dynein Heavy Chain 5 and Creatine Kinase Concentration in Cervical Fluid for Early Detection of the Ectopic Pregnancy Vitamin D in Ectopic Pregnancies Laparoscopic Tubal Preservation Surgery BHCG Level in Day 4,7, in Comparison to Day 10 as an Indicator for Treatment Success The Correlation Between Uterine Endometrial Pattern and Ectopic Pregnancy Adnexal Mass After Methotrexate Treatment for Ectopic Pregnancies The Impact of Salpingectomy and Single Dose Systemic Methotrexate Treatments on Ovarian Reserve in Ectopic Pregnancy Effectiveness Of Expectant Management In The Tubal Ectopic Pregnancy Methotrexate Treatment for Ectopic Pregnancy Comparison of Two Different Approaches in the Surgical Treatment of Tubal Ectopic Pregnancy Two-Dose Methotrexate for Ectopic Pregnancy Ectopic Pregnancy Biomarkers The Aromatase Inhibitor and Gnrh Antagonist Versus Methotrexate for Management of Undisturbed Ectopic Pregnancy Are Serum Levels of Vascular Endothelial Growth Factor a Marker for the Early Diagnosis of Ectopic Pregnancy? Risk Factors of Ectopic Pregnancy Assessment of Biomarkers in Ectopic Pregnancy Risk of Ectopic Pregnancy and Variation of Luteal Estradiol and Progesterone Levels in IVF

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


Primary Outcome

clinical pregnancy rate (CPR)

Secondary Outcome





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


* 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


Estimated Enrollment


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)




20 Years - 35 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers


Bulent Haydardedeoglu, Assoc.Prof., , 

Location Countries


Location Countries


Administrative Informations



Organization ID


Responsible Party


Study Sponsor

Bulent Haydardedeoglu

Study Sponsor

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

Verification Date

March 2019