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Hysteroscopic Surgery; Retrospective Cross-sectional Study of Reproductive Outcome

Sponsor
University of Jordan (Other)
Overall Status
Completed
CT.gov ID
NCT05560295
Collaborator
(none)
165
Enrollment
61
Actual Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Naser Al-Husban

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.

Study Design

Study Type:
Observational
Actual Enrollment :
165 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Fertility-enhancing Hysteroscopic Surgery; Multi-center Retrospective Cross-sectional Study of Reproductive Outcome
Actual Study Start Date :
Sep 1, 2016
Actual Primary Completion Date :
Apr 1, 2021
Actual Study Completion Date :
Oct 1, 2021

Outcome Measures

Primary Outcome Measures

  1. pregnancy rate [6 months]

    spontaneous

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 49 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Jordan

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Naser Al-Husban, Associate Professor, University of Jordan
ClinicalTrials.gov Identifier:
NCT05560295
Other Study ID Numbers:
  • Hysteroscopic surgery
First Posted:
Sep 29, 2022
Last Update Posted:
Sep 29, 2022
Last Verified:
Sep 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Sep 29, 2022