Hysteroscopic Metroplasty and MyomectomyNCT05560295
Hysteroscopic Surgery; Retrospective Cross-sectional Study of Reproductive Outcome
An observational study of Hysteroscopic Metroplasty and Myomectomy, run by University of Jordan.
Trial summary
study of the effect of hysteroscopic sptoplast and hysteroscopic myomectomy on reproductive performance of patients with infertility and /or miscarriages Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Hysteroscopic Metroplasty and Myomectomy
- What is being tested?
- Naser Al-Husban
- Type of treatment
- Surgery or procedure
- How many people
- 165 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- No healthy volunteers
- Adult
Study population: female population with infertility or recurrent miscarriages who have uterine septum or fibroids
Who may be able to join
- 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).
Who cannot join
- 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
About this study
Official title: Fertility-enhancing Hysteroscopic Surgery; Multi-center Retrospective Cross-sectional Study of Reproductive Outcome
study of the effect of hysteroscopic sptoplast and hysteroscopic myomectomy on reproductive performance of patients with infertility and /or miscarriages
Read the 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.
- Conditions
- Hysteroscopic Metroplasty and Myomectomy
- Being tested
- Naser Al-Husban
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naser Al-HusbanProcedure or surgery
uterine surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
pregnancy rate
spontaneous
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2022
- Study startSep 2016
- Primary completionApr 2021
- Study completionOct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hysteroscopic Metroplasty and MyomectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jordan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naser Al-Husban, University of Jordan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05560295
- Sponsor's protocol ID
- Hysteroscopic surgery
- Status last verified
- Sep 2022
- First submitted
- 26 Sep 2022
- Last updated
- 29 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37644542
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fertility-enhancing Hysteroscopic Surgery; Multi-center Retrospective Cross-sectional Study of Reproductive Outcome
- ClinicalTrials.gov ID
- NCT05560295
- Acronym / sponsor ID
- Hysteroscopic surgery
- Conditions
- Hysteroscopic Metroplasty and Myomectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- University of JordanUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- Apr 2021 (actual)
- Study completion
- Oct 2021 (actual)
- First posted
- 29 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- female population with infertility or recurrent miscarriages who have uterine septum or fibroids
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Naser Al-Husbanuterine surgery | Procedure or surgery | – |
Primary outcome
pregnancy rate
Time frame: 6 months
spontaneous
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2022.
- Derived from this study: PubMed 37644542Al-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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Hysteroscopic Metroplasty and Myomectomy, run by University of Jordan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pregnancy rate (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05560295, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2022.