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COH/IUI: Hysteroscopic Metroplasty in Unexplained Infertile Women With Dysmorphic Uterus

Sponsor
Bulent Haydardedeoglu (Other)
Overall Status
Unknown status
CT.gov ID
NCT03579550
Collaborator
(none)
86
Enrollment
1
Location
2
Arms
30.8
Anticipated Duration (Months)
2.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: office hysteroscopic metroplasty intervention arm
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
86 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
prospective randomised trialprospective randomised trial
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Comparison of Reproductive Outcomes of Hsyteroscopic Metroplasty Versus Spontaneous Coitus Plus COH/IUI Cycles in Unexplained Infertile Women With Dysmorphic Uterus
Actual Study Start Date :
Jun 8, 2018
Anticipated Primary Completion Date :
Dec 31, 2019
Anticipated Study Completion Date :
Dec 30, 2020

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Intervention arm: Hysterocopy group

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

Procedure: office hysteroscopic metroplasty intervention arm
One group will be performed hysteroscopic metroplasty Second group will be undertaken to six months spontaneous coitus and three cycles of COH/IUI
Other Names:
  • spontaneous coitus plus COH/IUI

    		•
    No Intervention: Spontaneous cycles plus COH/IUI

    Six months spontaneous coitus cycles plus 3 cycles of Clomiphene citrate and intrauterine insemination (COH/IUI)

    Outcome Measures

    Primary Outcome Measures

    1. clinical pregnancy rate (CPR) [9 months]

      Intrauterine gestational sac with viable fetal heart rate

    Secondary Outcome Measures

    1. abortion [10 weeks]

      the loss of pregnancy

    2. ectopic pregnancy rate [10 weeks]

      gestation with out of uterine cavity

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 35 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    Unexplained infertile couples with;

    1. Dysmorpic uterus in hysterosalpingography

    2. Normal spermiogram

    3. 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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Bulent Haydardedeoglu Adana Turkey 01120

    Sponsors and Collaborators

    • Bulent Haydardedeoglu

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Bulent Haydardedeoglu, Associate Prof. M.D., Baskent University
    ClinicalTrials.gov Identifier:
    NCT03579550
    Other Study ID Numbers:
    • KA17/151
    First Posted:
    Jul 6, 2018
    Last Update Posted:
    Mar 13, 2019
    Last Verified:
    Mar 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Bulent Haydardedeoglu, Associate Prof. M.D., Baskent University
    dysmorphic uterus, metroplasty, hysteroscopy
    Additional relevant MeSH terms:
    Pregnancy, Ectopic

    Study Results

    No Results Posted as of Mar 13, 2019