Hysteroscopic Surgery; Retrospective Cross-sectional Stud... | NCT05560295

Studies
Hysteroscopic Surgery; Retrospective Cross-sectional Study of Reproductive Outcome

NCT05560295

Sponsor

University of Jordan

Status

Completed

Last Update Posted

Sep 29, 2022Actual

Enrollment

165Actual

Phase

Not provided

Conditions

Hysteroscopic Metroplasty and Myomectomy

Interventions

Naser Al-Husban

Countries

Not provided

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

Sep 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2016Actual

Primary Completion Date

Apr 2021Actual

Completion Date

Oct 2021Actual

First Submitted Date

Sep 26, 2022

First Submission Date that Met QC Criteria

Sep 26, 2022

First Posted Date

Sep 29, 2022Actual

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

Sep 26, 2022

Last Update Posted Date

Sep 29, 2022Actual

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

study of the effect of hysteroscopic sptoplast and hysteroscopic myomectomy on reproductive performance of patients with infertility and /or miscarriages

Detailed Description

Retrospective study and analysis of the reproductive outcome in patients who underwent hysteroscopic surgery for infertility at Jordan university hospital and Al-Noor fertility centre in Amman, Jordan in the period September 2016-october 2021. Patients were followed up for a minimum of 6 months after surgery. Resection of uterine septum or submucosal fibroids were included. Data was obtained from the electronic and paper-based clinical files for patients who were operated upon at these hospitals. Patients who missed follow up after the operation will be contacted by phone or invite them for a clinic review to know of their fertility status and pregnancy outcome.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

165Actual

Name	Type	Description	Arm Group Labels	Other Names
Naser Al-Husban	Procedure	uterine surgery

Measure	Description	Time Frame
pregnancy rate	spontaneous	6 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

those with primary or secondary infertility of more than 1 year with normal seminal fluid analysis, normal female hormonal profile, patent fallopian tubes bilaterally (as confirmed by hysterosalpingography HSG), normal thyroid function, no previous uterine surgery and no medical diseases.
Cases with recurrent miscarriages were those with 2 or more first or second trimester miscarriages of an apparently normal singleton fetus with no hormonal, endocrine or maternal or paternal karyotype abnormalities and with no previous history of term pregnancy(s).

Exclusion Criteria:

All patients who were operated upon outside the context of infertility (heavy bleeding…etc), patients with combined (maternal and paternal) infertility factors,
Patients with history of any number of term pregnancy,
Previous uterine surgery,
Patients with medical diseases,
Those with abnormal female hormonal profile,
Those with other potential factors for infertility including endometriosis
Patients with incomplete or missing data and could not be contacted.
Patients who had myomectomy or septal resection done using bipolar hysteroscopy

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

infertility patients

Minimum Age

18 Years

Maximum Age

49 Years

Standard Ages

Adult

Study Population

female population with infertility or recurrent miscarriages who have uterine septum or fibroids

Sampling Method

Non-Probability Sample

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37644542	Derived	Al-Husban N, Odeh O, AlRamahi M, Qadri S, Al-Husban H. Fertility-enhancing hysteroscopic surgery; multi-center retrospective cohort study of reproductive outcome. BMC Womens Health. 2023 Aug 29;23(1):459. doi: 10.1186/s12905-023-02562-2.