Hysteroscopic Metroplasty in Unexplained Infertile Women With Dysmorphic Uterus

Ectopic Pregnancy Clinical Trial

— 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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03579550
• Other study ID #: KA17/151
• Status: Enrolling by invitation
• Phase: N/A
• Start date: June 8, 2018
• Est. completion date: December 30, 2020

Study information

• Verified date: March 2019
• Source: Baskent University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 86
• Est. completion date: December 30, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Turkey	Bulent Haydardedeoglu	Adana

Sponsors (1)

Lead Sponsor	Collaborator
Bulent Haydardedeoglu

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical pregnancy rate (CPR)	Intrauterine gestational sac with viable fetal heart rate	9 months
Secondary	abortion	the loss of pregnancy	10 weeks
Secondary	ectopic pregnancy rate	gestation with out of uterine cavity	10 weeks