Hysteroscopic Metroplasty in Unexplained Infertile Women... | NCT03579550

Studies
Hysteroscopic Metroplasty in Unexplained Infertile Women With Dysmorphic Uterus

NCT03579550

Sponsor

Bulent Haydardedeoglu

Status

Unknown status

Last Update Posted

Mar 13, 2019Actual

Enrollment

86Actual

Phase

Not Applicable

Conditions

Hysteroscopy
Pregnancy Rate
Abortion
Ectopic Pregnancy
Intrauterine Insemination

Interventions

office hysteroscopic metroplasty intervention arm

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 8, 2018Actual

Primary Completion Date

Dec 31, 2019Estimated

Completion Date

Dec 30, 2020Estimated

First Submitted Date

Jun 26, 2018

First Submission Date that Met QC Criteria

Jun 26, 2018

First Posted Date

Jul 6, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 11, 2019

Last Update Posted Date

Mar 13, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

86Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention arm: Hysterocopy group	Active Comparator	Office hyteroscopic metroplasty will be performed. After oparetion 9 months spontaneous conception Intervention arm for hysteroscopy group	Procedure: office hysteroscopic metroplasty intervention arm
Spontaneous cycles plus COH/IUI	No Intervention	Six months spontaneous coitus cycles plus 3 cycles of Clomiphene citrate and intrauterine insemination (COH/IUI)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
office hysteroscopic metroplasty intervention arm	Procedure	One group will be performed hysteroscopic metroplasty Second group will be undertaken to six months spontaneous coitus and three cycles of COH/IUI

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
clinical pregnancy rate (CPR)	Intrauterine gestational sac with viable fetal heart rate	9 months

Secondary Outcomes

Measure	Description	Time Frame
abortion	the loss of pregnancy	10 weeks
ectopic pregnancy rate	gestation with out of uterine cavity	10 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Unexplained infertile couples with;

Dysmorpic uterus in hysterosalpingography
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:

Women with history of pelvic surgery including endometriosis and/or tubal surgery
women with endometrioma which was visualised/suspected on transvaginal ultrasonography
Women with anovulation
Women with diminished ovarian reserve (AMH < 1.5 ng/dl and/or total bilateral antral follicle count <8)
Couples with abnormal spermiogram parameters (oligospermia, oligoasthenospermia, oligoasthenoteratozoospermia, azospermia)
Women with alive children
Obese women (BMI>30 kg/m2)

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

women with dysmorphic uterus

Minimum Age

20 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bulent Haydardedeoglu, Assoc.Prof.	Baskent University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bulent Haydardedeoglu		Adana		01120	Turkey (Türkiye)

Condition Browse Module

MeSH Terms

ID	Term
D011271	Pregnancy, Ectopic

Ancestor Terms

ID	Term
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

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Browse Branches

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