Abortion, Ectopic Pregnancy, Hysteroscopy, Intrauterine Insemination, Pregnancy Rate
Conditions
Keywords
dysmorphic uterus, metroplasty, hysteroscopy
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.
Interventions
PROCEDUREoffice 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
Sponsors
Bulent Haydardedeoglu
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
prospective randomised trial
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 35 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| clinical pregnancy rate (CPR) | 9 months | Intrauterine gestational sac with viable fetal heart rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| abortion | 10 weeks | the loss of pregnancy |
| ectopic pregnancy rate | 10 weeks | gestation with out of uterine cavity |
Countries
Turkey (Türkiye)
Outcome results
None listed