Hysteroscopic Metroplasty in Unexplained Infertile Women With Dysmorphic Uterus

Not Applicable

• Conditions: Intrauterine Insemination; Hysteroscopy; Pregnancy Rate; Ectopic Pregnancy; Abortion
• Interventions: Procedure: office hysteroscopic metroplasty intervention arm

• Registration Number: NCT03579550
• Lead Sponsor: Bulent Haydardedeoglu

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.

Study Timeline

• Study Start: 2018-06-08
• Study First Submitted: 2018-06-26
• Study First Submitted QC: 2018-06-26
• Study First Posted: 2018-07-06
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-11
• Last Update Posted: 2019-03-13
• Primary Completion: 2019-12-31
• Study Completion: 2020-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 86

Inclusion Criteria

Unexplained infertile couples with;

1. Dysmorpic uterus in hysterosalpingography

2. Normal spermiogram

3. 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention arm: Hysterocopy group	office hysteroscopic metroplasty intervention arm	Office hyteroscopic metroplasty will be performed. After oparetion 9 months spontaneous conception Intervention arm for hysteroscopy group

Primary Outcome Measures

Name	Time	Method
clinical pregnancy rate (CPR)	9 months	Intrauterine gestational sac with viable fetal heart rate

Secondary Outcome Measures

Name	Time	Method
ectopic pregnancy rate	10 weeks	gestation with out of uterine cavity
abortion	10 weeks	the loss of pregnancy

Trial Locations

Locations (1)

Bulent Haydardedeoglu; 🇹🇷 Adana, Turkey