Hysteroscopic Metroplasty in Unexplained Infertile Women With Dysmorphic Uterus (COH/IUI)
Primary Purpose
Hysteroscopy, Pregnancy Rate, Abortion
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
office hysteroscopic metroplasty intervention arm
Sponsored by
About this trial
This is an interventional treatment trial for Hysteroscopy focused on measuring dysmorphic uterus, metroplasty, hysteroscopy
Eligibility Criteria
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)
Sites / Locations
- Bulent Haydardedeoglu
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Intervention arm: Hysterocopy group
Spontaneous cycles plus COH/IUI
Arm Description
Office hyteroscopic metroplasty will be performed. After oparetion 9 months spontaneous conception Intervention arm for hysteroscopy group
Six months spontaneous coitus cycles plus 3 cycles of Clomiphene citrate and intrauterine insemination (COH/IUI)
Outcomes
Primary Outcome Measures
clinical pregnancy rate (CPR)
Intrauterine gestational sac with viable fetal heart rate
Secondary Outcome Measures
abortion
the loss of pregnancy
ectopic pregnancy rate
gestation with out of uterine cavity
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03579550
Brief Title
Hysteroscopic Metroplasty in Unexplained Infertile Women With Dysmorphic Uterus
Acronym
COH/IUI
Official Title
The Comparison of Reproductive Outcomes of Hsyteroscopic Metroplasty Versus Spontaneous Coitus Plus COH/IUI Cycles in Unexplained Infertile Women With Dysmorphic Uterus
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 8, 2018 (Actual)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
December 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Bulent Haydardedeoglu
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hysteroscopy, Pregnancy Rate, Abortion, Ectopic Pregnancy, Intrauterine Insemination
Keywords
dysmorphic uterus, metroplasty, hysteroscopy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
prospective randomised trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
86 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention arm: Hysterocopy group
Arm Type
Active Comparator
Arm Description
Office hyteroscopic metroplasty will be performed. After oparetion 9 months spontaneous conception Intervention arm for hysteroscopy group
Arm Title
Spontaneous cycles plus COH/IUI
Arm Type
No Intervention
Arm Description
Six months spontaneous coitus cycles plus 3 cycles of Clomiphene citrate and intrauterine insemination (COH/IUI)
Intervention Type
Procedure
Intervention Name(s)
office hysteroscopic metroplasty intervention arm
Other Intervention Name(s)
spontaneous coitus plus COH/IUI
Intervention Description
One group will be performed hysteroscopic metroplasty Second group will be undertaken to six months spontaneous coitus and three cycles of COH/IUI
Primary Outcome Measure Information:
Title
clinical pregnancy rate (CPR)
Description
Intrauterine gestational sac with viable fetal heart rate
Time Frame
9 months
Secondary Outcome Measure Information:
Title
abortion
Description
the loss of pregnancy
Time Frame
10 weeks
Title
ectopic pregnancy rate
Description
gestation with out of uterine cavity
Time Frame
10 weeks
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
women with dysmorphic uterus
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bulent Haydardedeoglu, Assoc.Prof.
Organizational Affiliation
Baskent University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bulent Haydardedeoglu
City
Adana
ZIP/Postal Code
01120
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
Hysteroscopic Metroplasty in Unexplained Infertile Women With Dysmorphic Uterus
We'll reach out to this number within 24 hrs