NCT03579550

Hysteroscopic Metroplasty in Unexplained Infertile Women With Dysmorphic Uterus

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 86 (actual)
• Sponsor: Bulent Haydardedeoglu · Academic / Other
• Sex: Female
• Age: 20 Years – 35 Years
• Healthy volunteers: Accepted

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.

Conditions

• Hysteroscopy
• Pregnancy Rate
• Abortion
• Ectopic Pregnancy
• Intrauterine Insemination

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-06-08
• Primary completion: 2019-12-31
• Completion: 2020-12-30
• First posted: 2018-07-06
• Last updated: 2019-03-13

Locations

1 site across 1 country: Turkey (Türkiye)