Perimenopausal BleedingNCT07309692
Different Modalities for the Evaluation of Patients With Peri-menopausal Bleeding
A study testing three dimensional ultrasonography and Hysteroscopy in people with Perimenopausal Bleeding, run by Sohag University at 1 site in Egypt.
Trial summary
The study aims to compare between 3D ultrasonography and hysteroscopy for the evaluation of cases with Peri-menopausal bleeding Read more about this study
- Who is it for?
- Ages 40 to 55 years, women only
- Conditions the study is for
- Perimenopausal Bleeding
- What is being tested?
- three dimensional ultrasonography and Hysteroscopy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2025to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Any pattern of abnormal uterine bleeding as menorrhagia or metrorrhagia for more than 3 months at age between 40 and 55 years , and no ovarian lesion or local cause of bleeding as vaginal or cervical ulcer
Who cannot join
- • Women with postmenopausal bleeding.
- Systemic causes of perimenopausal bleeding DM Hypertension or chronic liver disease.
- Women on hormonal therapy or using any contraception as IUD.
- Women have contraindication for hysteroscopy as cervical stenosis or pregnancy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
ahmed abdelrahem fattouh, resident of Obstetrics and Gyn contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag University
Sohag
hatem aboelftooh awaga, assistant professor, 01550777310, hatemaboelftooh@yahoo.com
About this study
Official title: Three Dimensional Ultrasonography Versus Hysteroscopy for the Evaluation of Patients With Perimenopausal Bleeding
The study aims to compare between 3D ultrasonography and hysteroscopy for the evaluation of cases with Peri-menopausal bleeding
- Conditions
- Perimenopausal Bleeding
- Being tested
- three dimensional ultrasonography, Hysteroscopy
- Keywords
- ultrasonography, hysteroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
three dimensional ultrasonographyDiagnostic test
all recruited patients will be subjected to three dimensional ultrasonography to diagnose the cause of perimenopausal bleeding
HysteroscopyDiagnostic test
diagnostic hysteroscopy will be performed to diagnose the cause of perimenopausal bleeding
| Study group | Role | What they receive |
|---|---|---|
| Patients with perimenopausal bleeding | Experimental | Not described Receives: Diagnostic Test: three dimensional ultrasonography; Diagnostic Test: Hysteroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The sensitivity and specificity of the 3D ultrasonography for the diagnosis of the causes of peri-menopausal bleeding as compared to hysteroscopy
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start1 Dec 2025
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Perimenopausal BleedingStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abd Al Rahim Fattouh, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07309692
- Sponsor's protocol ID
- Soh-Med-25-9----11MS
- Status last verified
- Dec 2025
- First submitted
- 27 Nov 2025
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Dokara-Friedrich ML, Loeffler M, Shehaj I, Tahmasbi-Rad M, Gasimli B, Karn T, Sanhaji M, Becker S, Gasimli K. The Clinical Relevance of Fractional Curettage in the Diagnostic Management of Primary Endometrial Cancer. Gynecol Obstet Invest. 2024;89(4):311-322. doi: 10.1159/000538268. Epub 2024 Mar 12.
PubMed 38471484Saponara S, Angioni S, Parry JP, Pacheco LA, Carugno J, Moawad N, Haimovich S, Lasmar RB, Dealberti D, Aksakal E, Urman B, Nappi L, Vitale SG. The Pivotal role of hysteroscopy in diagnosing subtle uterine lesions in infertile patients: Seeing the unseen can make the difference. Eur J Obstet Gynecol Reprod Biol. 2025 Feb;305:132-141. doi: 10.1016/j.ejogrb.2024.12.013. Epub 2024 Dec 9.
PubMed 39701007Xydias EM, Liasidi PN, Papageorgouli D, Tsakos E, Gouliopoulos N, Thanasas I, Daponte A, Ziogas AC. Three-dimensional transvaginal ultrasound versus MRI in the diagnosis and classification of congenital uterine anomalies: A systematic review and meta-analysis. Eur J Obstet Gynecol Reprod Biol. 2025 Aug;312:114560. doi: 10.1016/j.ejogrb.2025.114560. Epub 2025 Jul 2.
PubMed 40628082Tetlow RL, Richmond I, Manton DJ, Greenman J, Turnbull LW, Killick SR. Histological analysis of the uterine junctional zone as seen by transvaginal ultrasound. Ultrasound Obstet Gynecol. 1999 Sep;14(3):188-93. doi: 10.1046/j.1469-0705.1999.14030188.x.
PubMed 10550879Okaro E, Condous G, Khalid A, Timmerman D, Ameye L, Huffel SV, Bourne T. The use of ultrasound-based 'soft markers' for the prediction of pelvic pathology in women with chronic pelvic pain--can we reduce the need for laparoscopy? BJOG. 2006 Mar;113(3):251-6. doi: 10.1111/j.1471-0528.2006.00849.x.
PubMed 16487194Mukhopadhayay S, Bhattacharyya SK, Ganguly RP, Patra KK, Bhattacharya N, Barman SC. Comparative evaluation of perimenopausal abnormal uterine bleeding by transvaginal sonography, hysteroscopy and endometrial biopsy. J Indian Med Assoc. 2007 Nov;105(11):624, 626, 628 passim.
PubMed 18405088Babacan A, Gun I, Kizilaslan C, Ozden O, Muhcu M, Mungen E, Atay V. Comparison of transvaginal ultrasonography and hysteroscopy in the diagnosis of uterine pathologies. Int J Clin Exp Med. 2014 Mar 15;7(3):764-9. eCollection 2014.
PubMed 24753775Louis F, Lulla CP. Hysteroscopy is Superior to 3D Ultrasound in Gynecological Diagnosis. J Obstet Gynaecol India. 2020 Dec;70(6):447-461. doi: 10.1007/s13224-020-01384-8. Epub 2020 Dec 4. No abstract available.
PubMed 33417634Kolhe S. Management of abnormal uterine bleeding - focus on ambulatory hysteroscopy. Int J Womens Health. 2018 Mar 22;10:127-136. doi: 10.2147/IJWH.S98579. eCollection 2018.
PubMed 29606892Yasa C, Gungor Ugurlucan F. Approach to Abnormal Uterine Bleeding in Adolescents. J Clin Res Pediatr Endocrinol. 2020 Feb 6;12(Suppl 1):1-6. doi: 10.4274/jcrpe.galenos.2019.2019.S0200.
PubMed 32041387Pandey D, Kunamneni S, Inukollu PR, Su H. Establishing patterns on hysteroscopy in abnormal uterine bleeding (AUB). Gynecol Minim Invasive Ther. 2017 Oct-Dec;6(4):178-182. doi: 10.1016/j.gmit.2017.08.001. Epub 2017 Aug 26.
PubMed 30254909Ong CL. The current status of three-dimensional ultrasonography in gynaecology. Ultrasonography. 2016 Jan;35(1):13-24. doi: 10.14366/usg.15043. Epub 2015 Sep 25.
PubMed 26537304Turkgeldi E, Urman B, Ata B. Role of Three-Dimensional Ultrasound in Gynecology. J Obstet Gynaecol India. 2015 May;65(3):146-54. doi: 10.1007/s13224-014-0635-z. Epub 2014 Nov 8.
PubMed 26085733Wang L, Quan S, Bai E, Yang X. Analysis of clinical data of different endometrial pathological types in perimenopausal women with abnormal uterine bleeding. Front Oncol. 2024 Feb 29;14:1370681. doi: 10.3389/fonc.2024.1370681. eCollection 2024.
PubMed 38487719Dreisler E, Frandsen CS, Ulrich L. Perimenopausal abnormal uterine bleeding. Maturitas. 2024 Jun;184:107944. doi: 10.1016/j.maturitas.2024.107944. Epub 2024 Feb 22.
PubMed 38412750
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three Dimensional Ultrasonography Versus Hysteroscopy for the Evaluation of Patients With Perimenopausal Bleeding
- ClinicalTrials.gov ID
- NCT07309692
- Acronym / sponsor ID
- Soh-Med-25-9----11MS
- Conditions
- Perimenopausal Bleeding
- Keywords
- ultrasonography, hysteroscopy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 30 Dec 2025 (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.
The study aims to compare between 3D ultrasonography and hysteroscopy for the evaluation of cases with Peri-menopausal bleeding
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with perimenopausal bleeding | Experimental | Diagnostic Test: three dimensional ultrasonography, Diagnostic Test: Hysteroscopy |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Any pattern of abnormal uterine bleeding as menorrhagia or metrorrhagia for more than 3 months at age between 40 and 55 years , and no ovarian lesion or local cause of bleeding as vaginal or cervical ulcer
Key exclusion criteria (4 listed)
- • Women with postmenopausal bleeding.
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 |
|---|---|---|
| three dimensional ultrasonographyall recruited patients will be subjected to three dimensional ultrasonography to diagnose the cause of perimenopausal bleeding | Diagnostic test | Patients with perimenopausal bleeding |
| Hysteroscopydiagnostic hysteroscopy will be performed to diagnose the cause of perimenopausal bleeding | Diagnostic test | Patients with perimenopausal bleeding |
Primary outcome
The sensitivity and specificity of the 3D ultrasonography for the diagnosis of the causes of peri-menopausal bleeding as compared to hysteroscopy
Time frame: 9 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
- Results publication: PubMed 38471484Dokara-Friedrich ML, Loeffler M, Shehaj I, Tahmasbi-Rad M, Gasimli B, Karn T, Sanhaji M, Becker S, Gasimli K. The Clinical Relevance of Fractional Curettage in the Diagnostic Management of Primary Endometrial Cancer. Gynecol Obstet Invest. 2024;89(4):311-322. doi: 10.1159/000538268. Epub 2024 Mar 12.
- Results publication: PubMed 39701007Saponara S, Angioni S, Parry JP, Pacheco LA, Carugno J, Moawad N, Haimovich S, Lasmar RB, Dealberti D, Aksakal E, Urman B, Nappi L, Vitale SG. The Pivotal role of hysteroscopy in diagnosing subtle uterine lesions in infertile patients: Seeing the unseen can make the difference. Eur J Obstet Gynecol Reprod Biol. 2025 Feb;305:132-141. doi: 10.1016/j.ejogrb.2024.12.013. Epub 2024 Dec 9.
- Results publication: PubMed 40628082Xydias EM, Liasidi PN, Papageorgouli D, Tsakos E, Gouliopoulos N, Thanasas I, Daponte A, Ziogas AC. Three-dimensional transvaginal ultrasound versus MRI in the diagnosis and classification of congenital uterine anomalies: A systematic review and meta-analysis. Eur J Obstet Gynecol Reprod Biol. 2025 Aug;312:114560. doi: 10.1016/j.ejogrb.2025.114560. Epub 2025 Jul 2.
- Results publication: PubMed 10550879Tetlow RL, Richmond I, Manton DJ, Greenman J, Turnbull LW, Killick SR. Histological analysis of the uterine junctional zone as seen by transvaginal ultrasound. Ultrasound Obstet Gynecol. 1999 Sep;14(3):188-93. doi: 10.1046/j.1469-0705.1999.14030188.x.
- Results publication: PubMed 16487194Okaro E, Condous G, Khalid A, Timmerman D, Ameye L, Huffel SV, Bourne T. The use of ultrasound-based 'soft markers' for the prediction of pelvic pathology in women with chronic pelvic pain--can we reduce the need for laparoscopy? BJOG. 2006 Mar;113(3):251-6. doi: 10.1111/j.1471-0528.2006.00849.x.
- Results publication: PubMed 18405088Mukhopadhayay S, Bhattacharyya SK, Ganguly RP, Patra KK, Bhattacharya N, Barman SC. Comparative evaluation of perimenopausal abnormal uterine bleeding by transvaginal sonography, hysteroscopy and endometrial biopsy. J Indian Med Assoc. 2007 Nov;105(11):624, 626, 628 passim.
- Results publication: PubMed 24753775Babacan A, Gun I, Kizilaslan C, Ozden O, Muhcu M, Mungen E, Atay V. Comparison of transvaginal ultrasonography and hysteroscopy in the diagnosis of uterine pathologies. Int J Clin Exp Med. 2014 Mar 15;7(3):764-9. eCollection 2014.
- Results publication: PubMed 33417634Louis F, Lulla CP. Hysteroscopy is Superior to 3D Ultrasound in Gynecological Diagnosis. J Obstet Gynaecol India. 2020 Dec;70(6):447-461. doi: 10.1007/s13224-020-01384-8. Epub 2020 Dec 4. No abstract available.
- Results publication: PubMed 29606892Kolhe S. Management of abnormal uterine bleeding - focus on ambulatory hysteroscopy. Int J Womens Health. 2018 Mar 22;10:127-136. doi: 10.2147/IJWH.S98579. eCollection 2018.
- Results publication: PubMed 32041387Yasa C, Gungor Ugurlucan F. Approach to Abnormal Uterine Bleeding in Adolescents. J Clin Res Pediatr Endocrinol. 2020 Feb 6;12(Suppl 1):1-6. doi: 10.4274/jcrpe.galenos.2019.2019.S0200.
- Results publication: PubMed 30254909Pandey D, Kunamneni S, Inukollu PR, Su H. Establishing patterns on hysteroscopy in abnormal uterine bleeding (AUB). Gynecol Minim Invasive Ther. 2017 Oct-Dec;6(4):178-182. doi: 10.1016/j.gmit.2017.08.001. Epub 2017 Aug 26.
- Results publication: PubMed 26537304Ong CL. The current status of three-dimensional ultrasonography in gynaecology. Ultrasonography. 2016 Jan;35(1):13-24. doi: 10.14366/usg.15043. Epub 2015 Sep 25.
- Individual participant dataSharing planned: Undecided
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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.
ahmed abdelrahem fattouh, resident of Obstetrics and Gyn contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing three dimensional ultrasonography and Hysteroscopy in people with Perimenopausal Bleeding, run by Sohag University at 1 site in Egypt.
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 1 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ahmed abdelrahem fattouh, resident of Obstetrics and Gyn (00201146329946, ahmedalatoon04@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The sensitivity and specificity of the 3D ultrasonography for the diagnosis of the causes of peri-menopausal bleeding as compared to hysteroscopy (time frame: 9 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 NCT07309692, which also lists 15 linked publications.
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 30 Dec 2025.