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

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

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.

Study Overview

• Status: Unknown
• Conditions: Hysteroscopy; Ectopic Pregnancy; Abortion; Pregnancy Rate; Intrauterine Insemination
• Intervention / Treatment: Procedure: office hysteroscopic metroplasty intervention arm

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 Type: Interventional
• Enrollment (Actual): 86
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Adana, Turkey, 01120
    • Bulent Haydardedeoglu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Bulent Haydardedeoglu
• Investigators: Principal Investigator: Bulent Haydardedeoglu, Assoc.Prof., Başkent University

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2018
• Primary Completion (Anticipated): December 31, 2019
• Study Completion (Anticipated): December 30, 2020

Study Registration Dates

• First Submitted: June 26, 2018
• First Submitted That Met QC Criteria: June 26, 2018
• First Posted (Actual): July 6, 2018

Study Record Updates

• Last Update Posted (Actual): March 13, 2019
• Last Update Submitted That Met QC Criteria: March 11, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: dysmorphic uterus, metroplasty, hysteroscopy
• Additional Relevant MeSH Terms: Pregnancy Complications; Pregnancy, Ectopic
• Other Study ID Numbers: KA17/151

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No