Clinical trial NCT03579550: Hysteroscopic Metroplasty in Unexplained Infertile Women With Dysmorphic Uterus
Official title: The Comparison of Reproductive Outcomes of Hsyteroscopic Metroplasty Versus Spontaneous Coitus Plus COH/IUI Cycles in Unexplained Infertile Women With Dysmorphic Uterus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hysteroscopy
Pregnancy Rate
Abortion
Ectopic Pregnancy
Intrauterine Insemination
Keywords: dysmorphic uterus, metroplasty, hysteroscopy
Lead sponsor: Baskent University
Sponsor class: OTHER
First posted: 2018-07-06
Enrollment: 86
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective randomised trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: clinical pregnancy rate (CPR)
timeFrame: 9 months
Secondary outcomes:
measure: abortion
timeFrame: 10 weeks
measure: ectopic pregnancy rate
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Bulent Haydardedeoglu
Study officials:
affiliation: Baskent University
name: Bulent Haydardedeoglu, Assoc.Prof.
role: PRINCIPAL_INVESTIGATOR
References: