Hysteroscopic Metroplasty in Unexplained Infertile Women With Dysmorphic Uterus

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-08

Study Completion Date

2020-12-30

Brief Summary

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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.

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Detailed Description

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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

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Hysteroscopy Pregnancy Rate Abortion Ectopic Pregnancy Intrauterine Insemination

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

prospective randomised trial

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention arm: Hysterocopy group

Office hyteroscopic metroplasty will be performed. After oparetion 9 months spontaneous conception Intervention arm for hysteroscopy group

Group Type ACTIVE_COMPARATOR

office hysteroscopic metroplasty intervention arm

Intervention Type PROCEDURE

One group will be performed hysteroscopic metroplasty Second group will be undertaken to six months spontaneous coitus and three cycles of COH/IUI

Spontaneous cycles plus COH/IUI

Six months spontaneous coitus cycles plus 3 cycles of Clomiphene citrate and intrauterine insemination (COH/IUI)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type PROCEDURE

Other Intervention Names

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spontaneous coitus plus COH/IUI

Eligibility Criteria

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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)

Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes