NCT05560295

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
165

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2016

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 26, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 29, 2022

Completed
Last Updated

September 29, 2022

Status Verified

September 1, 2022

Enrollment Period

4.6 years

First QC Date

September 26, 2022

Last Update Submit

September 26, 2022

Conditions

Hysteroscopic Metroplasty and Myomectomy

Outcome Measures

Primary Outcomes (1)

  • pregnancy rate

    spontaneous

    6 months

Interventions

Naser Al-HusbanPROCEDURE

uterine surgery

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsinfertility patients
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 37644542DERIVED

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 26, 2022

First Posted

September 29, 2022

Study Start

September 1, 2016

Primary Completion

April 1, 2021

Study Completion

October 1, 2021

Last Updated

September 29, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share