Hysteroscopic Metroplasty in Unexplained Infertile Women With Dysmorphic Uterus

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hysteroscopy, Pregnancy Rate, Abortion, Ectopic Pregnancy, Intrauterine Insemination

Intervention / Treatment
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* Procedure: office hysteroscopic metroplasty intervention arm


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Unexplained infertile couples with; Dysmorpic uterus in hysterosalpingography 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: Women with history of pelvic surgery including endometriosis and/or tubal surgery women with endometrioma which was visualised/suspected on transvaginal ultrasonography Women with anovulation Women with diminished ovarian reserve (AMH < 1.5 ng/dl and/or total bilateral antral follicle count <8) Couples with abnormal spermiogram parameters (oligospermia, oligoasthenospermia, oligoasthenoteratozoospermia, azospermia) Women with alive children Obese women (BMI>30 kg/m2)

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: prospective randomised trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention arm: Hysterocopy group<br>Office hyteroscopic metroplasty will be performed. After oparetion 9 months spontaneous conception Intervention arm for hysteroscopy group | Procedure: office hysteroscopic metroplasty intervention arm<br>* One group will be performed hysteroscopic metroplasty Second group will be undertaken to six months spontaneous coitus and three cycles of COH/IUI<br>* Other names: spontaneous coitus plus COH/IUI;|
| No Intervention: Spontaneous cycles plus COH/IUI<br>Six months spontaneous coitus cycles plus 3 cycles of Clomiphene citrate and intrauterine insemination (COH/IUI) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical pregnancy rate (CPR) | Intrauterine gestational sac with viable fetal heart rate | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| abortion | the loss of pregnancy | 10 weeks | 
| ectopic pregnancy rate | gestation with out of uterine cavity | 10 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dysmorphic uterus, metroplasty, hysteroscopy