Mullerian Duct AnomaliesNCT06110052
Clinical Presentations and Surgical Outcome of Obstructive Müllerian Anomalies
An observational study of Mullerian Duct Anomalies, run by Assiut University at 1 site in Egypt.
Trial summary
The present study aims at: A. The main outcome is to compare preoperative and postoperative visual analog scale VAS from 0 to 10 of maximum perceived pain in ladies with OMAs. 1. description of clinical presentation and percentage of OMAs in relation to other Mullerian anomalies 2. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Mullerian Duct Anomalies
- What is being tested?
- prospective follow up
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2022to 1 Dec 2023
- How long will I take part?
- 3 Months
- 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 Any age
- Women only
- Child, Adult, Older adult
Study population: demographic data will be collected about age, marital status, menarche, parity, consanguinity and family history. detailed history: about complaint and presenting symptoms will be obtained as delayed menarche, cyclic pain, abdominal distention, dull aching abdominal pain, dyspareunia and infertility physical examination: * general examination for secondary sexual characters, other anomalies * abdominal examination for abdominal mass, tenderness * genital examination by inspection for bulging hymen, per-vaginal examination * per- rectal examination investigation : CBC,, transvaginal, per-rectal, 3D abdominal ultrasonography Diagnosis: Anomalies will be categorized according to ESHRE classification 2016 Surgical procedure: follow up for the patient for three months for symptoms improvement and any complications.
Who may be able to join
- All cases with OMAs or H-OMAs
Who cannot join
- Cases who refuse to participate in the study. 2.Cases who underwent previous surgical repair for their OMA or H-OMA.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Assiut Medical School
Asyut, 71511
dina A mohamed, MBBCH, 01090054328, dinaelsaman@yahoo.com
About this study
Official title: Clinical Presentations and Surgical Outcome of Obstructive Müllerian Anomalies: A Prospective Cohort Study
The present study aims at:
- The main outcome is to compare preoperative and postoperative visual analog scale VAS from 0 to 10 of maximum perceived pain in ladies with OMAs.
- description of clinical presentation and percentage of OMAs in relation to other Mullerian anomalies
- description of different subtypes and its percentage.
- description of the corrective procedures and their short-term outcomes.
Read the detailed description
Obstructive Mullerian anomalies (OMAs) represent a real challenge in diagnosis and treatment, its incidence is not yet recognized. Care givers and gynecologist should be aware with its clinical presentation to avoid its delayed diagnosis and misdiagnosis. In addition, delayed diagnoses may result in retrograde menstruation, recurrent cyclic pains, chronic pelvic pains, poor quality of life and threats to future fertility.
Cases with complete obstructive Müllerian anomalies (C-OMAs) classically present with recurrent cyclic pains at puberty and their diagnosis is usually established easily. However, cases with Hemi obstructive anomalies (H-OMA) usually present with progressive dysmenorrhea and delayed diagnosis may result in pelvic adhesions, progressive hematosalpinx and endometriosis which directly threats natural future fertility. H-OMAs may results from obstructing uterine septa or unilateral cervical obstruction in a double uterus. Also, it may result from obstructing longitudinal vaginal septa in cases with double uterus, septate uterus or hybrid septate uterus .
A hybrid uterine anomaly is relatively a recent term that described the coexistence of septate and bicornuate uterus together. Pure septate uterus has a convex or flat fundus, when there is any fundal depression, it is termed hybrid septate uterus.
Pain with or without amenorrhoea is the main presentation of OMAs. Surgical correction should improve these symptoms. To the best of our knowledge there is no published prospective trials compared visual analog scale VAS in ladies with OMAs before and after surgical correction.
- Conditions
- Mullerian Duct Anomalies
- Being tested
- prospective follow up
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prospective follow upOther
compare preoperative and postoperative visual analog scale VAS of maximum perceived pain in ladies with OMAs
What is being measured
The primary outcome is the main question the study is designed to answer.
mullerian duct anomalies
- The main outcome is to compare preoperative and postoperative visual analog scale VAS of maximum perceived pain in ladies with OMAs.
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study start1 Dec 2022
- Primary completion1 Aug 2023
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Mullerian Duct AnomaliesStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 36 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Ali Mahmoud Mohamed, Assiut University
- Investigators
- Ahmed F Amin, professor, Study chair, Assiut medical school
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06110052
- Sponsor's protocol ID
- OMAs
- Status last verified
- Oct 2023
- First submitted
- 3 Aug 2023
- Last updated
- 31 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
El Saman AM. Combined retropubic balloon vaginoplasty and laparoscopic canalization: a novel blend of techniques provides a minimally invasive treatment for cervicovaginal aplasia. Am J Obstet Gynecol. 2009 Sep;201(3):333.e1-5. doi: 10.1016/j.ajog.2009.07.001.
PubMed 19733291El Saman AM. Endoscopically monitored canalization for treatment of congenital cervical atresia: the least invasive approach. Fertil Steril. 2010 Jun;94(1):313-6. doi: 10.1016/j.fertnstert.2009.02.079. Epub 2009 May 21.
PubMed 19463998Fedele L, Bianchi S, Frontino G, Berlanda N, Montefusco S, Borruto F. Laparoscopically assisted uterovestibular anastomosis in patients with uterine cervix atresia and vaginal aplasia. Fertil Steril. 2008 Jan;89(1):212-6. doi: 10.1016/j.fertnstert.2007.01.168. Epub 2007 May 4.
PubMed 17482183Li M, Zhang Z. Laparoscopically assisted biomaterial graft for reconstruction in congenital atresia of vagina and cervix. Fertil Steril. 2013 Dec;100(6):1784-7. doi: 10.1016/j.fertnstert.2013.08.046. Epub 2013 Sep 29.
PubMed 24083872El Saman AM, Shahin AY, Nasr A, Tawfik RM, Saadeldeen HS, Othman ER, Habib DM, Abdel-Aleem MA. Hybrid septate uterus, coexistence of bicornuate and septate varieties: a genuine report. J Obstet Gynaecol Res. 2012 Nov;38(11):1308-14. doi: 10.1111/j.1447-0756.2012.01866.x. Epub 2012 May 21.
PubMed 22612567El Saman AM, Nasr A, Tawfik RM, Saadeldeen HS. Mullerian duct anomalies: successful endoscopic management of a hybrid bicornuate/septate variety. J Pediatr Adolesc Gynecol. 2011 Aug;24(4):e89-92. doi: 10.1016/j.jpag.2011.02.013. Epub 2011 Apr 21.
PubMed 21514191Ozbey H, Morozov D, Morozov DA. Abdominal pain as the presentation of imperforate hymen in a teenage girl. Pediatr Int. 2022 Jan;64(1):e15168. doi: 10.1111/ped.15168. No abstract available.
PubMed 35438216Rozalska B, Sakata N, Wadstrom T. Staphylococcus aureus fibronectin-binding proteins (FnBPs). Identification of antigenic epitopes using polyclonal antibodies. APMIS. 1994 Feb;102(2):112-8.
PubMed 8167006
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Presentations and Surgical Outcome of Obstructive Müllerian Anomalies: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06110052
- Acronym / sponsor ID
- OMAs
- Conditions
- Mullerian Duct Anomalies
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 31 Oct 2023 (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 present study aims at:
- The main outcome is to compare preoperative and postoperative visual analog scale VAS from 0 to 10 of maximum perceived pain in ladies with OMAs.
- description of clinical presentation and percentage of OMAs in relation to other Mullerian anomalies
- description of different subtypes and its percentage.
- description of the corrective procedures and their short-term outcomes.
Detailed description
Obstructive Mullerian anomalies (OMAs) represent a real challenge in diagnosis and treatment, its incidence is not yet recognized. Care givers and gynecologist should be aware with its clinical presentation to avoid its delayed diagnosis and misdiagnosis. In addition, delayed diagnoses may result in retrograde menstruation, recurrent cyclic pains, chronic pelvic pains, poor quality of life and threats to future fertility.
Cases with complete obstructive Müllerian anomalies (C-OMAs) classically present with recurrent cyclic pains at puberty and their diagnosis is usually established easily. However, cases with Hemi obstructive anomalies (H-OMA) usually present with progressive dysmenorrhea and delayed diagnosis may result in pelvic adhesions, progressive hematosalpinx and endometriosis which directly threats natural future fertility. H-OMAs may results from obstructing uterine septa or unilateral cervical obstruction in a double uterus. Also, it may result from obstructing longitudinal vaginal septa in cases with double uterus, septate uterus or hybrid septate uterus .
A hybrid uterine anomaly is relatively a recent term that described the coexistence of septate and bicornuate uterus together. Pure septate uterus has a convex or flat fundus, when there is any fundal depression, it is termed hybrid septate uterus.
Pain with or without amenorrhoea is the main presentation of OMAs. Surgical correction should improve these symptoms. To the best of our knowledge there is no published prospective trials compared visual analog scale VAS in ladies with OMAs before and after surgical correction.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Sex
- Female only
- Age groups
- Child, Adult, Older adult
- Study population
- demographic data will be collected about age, marital status, menarche, parity, consanguinity and family history. detailed history: about complaint and presenting symptoms will be obtained as delayed menarche, cyclic pain, abdominal distention, dull aching abdominal pain, dyspareunia and infertility physical examination: * general examination for secondary sexual characters, other anomalies * abdominal examination for abdominal mass, tenderness * genital examination by inspection for bulging hymen, per-vaginal examination * per- rectal examination investigation : CBC,, transvaginal, per-rectal, 3D abdominal ultrasonography Diagnosis: Anomalies will be categorized according to ESHRE classification 2016 Surgical procedure: follow up for the patient for three months for symptoms improvement and any complications.
Key inclusion criteria (1 listed)
- All cases with OMAs or H-OMAs
Key exclusion criteria (1 listed)
- Cases who refuse to participate in the study. 2.Cases who underwent previous surgical repair for their OMA or H-OMA.
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 |
|---|---|---|
| prospective follow upcompare preoperative and postoperative visual analog scale VAS of maximum perceived pain in ladies with OMAs | Other | – |
Primary outcome
mullerian duct anomalies
Time frame: 48 months
A. The main outcome is to compare preoperative and postoperative visual analog scale VAS of maximum perceived pain in ladies with OMAs.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
- Results publication: PubMed 19733291El Saman AM. Combined retropubic balloon vaginoplasty and laparoscopic canalization: a novel blend of techniques provides a minimally invasive treatment for cervicovaginal aplasia. Am J Obstet Gynecol. 2009 Sep;201(3):333.e1-5. doi: 10.1016/j.ajog.2009.07.001.
- Results publication: PubMed 19463998El Saman AM. Endoscopically monitored canalization for treatment of congenital cervical atresia: the least invasive approach. Fertil Steril. 2010 Jun;94(1):313-6. doi: 10.1016/j.fertnstert.2009.02.079. Epub 2009 May 21.
- Results publication: PubMed 17482183Fedele L, Bianchi S, Frontino G, Berlanda N, Montefusco S, Borruto F. Laparoscopically assisted uterovestibular anastomosis in patients with uterine cervix atresia and vaginal aplasia. Fertil Steril. 2008 Jan;89(1):212-6. doi: 10.1016/j.fertnstert.2007.01.168. Epub 2007 May 4.
- Results publication: PubMed 24083872Li M, Zhang Z. Laparoscopically assisted biomaterial graft for reconstruction in congenital atresia of vagina and cervix. Fertil Steril. 2013 Dec;100(6):1784-7. doi: 10.1016/j.fertnstert.2013.08.046. Epub 2013 Sep 29.
- Results publication: PubMed 22612567El Saman AM, Shahin AY, Nasr A, Tawfik RM, Saadeldeen HS, Othman ER, Habib DM, Abdel-Aleem MA. Hybrid septate uterus, coexistence of bicornuate and septate varieties: a genuine report. J Obstet Gynaecol Res. 2012 Nov;38(11):1308-14. doi: 10.1111/j.1447-0756.2012.01866.x. Epub 2012 May 21.
- Results publication: PubMed 21514191El Saman AM, Nasr A, Tawfik RM, Saadeldeen HS. Mullerian duct anomalies: successful endoscopic management of a hybrid bicornuate/septate variety. J Pediatr Adolesc Gynecol. 2011 Aug;24(4):e89-92. doi: 10.1016/j.jpag.2011.02.013. Epub 2011 Apr 21.
- Results publication: PubMed 35438216Ozbey H, Morozov D, Morozov DA. Abdominal pain as the presentation of imperforate hymen in a teenage girl. Pediatr Int. 2022 Jan;64(1):e15168. doi: 10.1111/ped.15168. No abstract available.
- Results publication: PubMed 8167006Rozalska B, Sakata N, Wadstrom T. Staphylococcus aureus fibronectin-binding proteins (FnBPs). Identification of antigenic epitopes using polyclonal antibodies. APMIS. 1994 Feb;102(2):112-8.
- 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.
Ahmed F Amin, professor study chair
Assiut medical school
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mullerian Duct Anomalies, run by Assiut 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 1 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: status not confirmed, as of the sponsor's last update on 31 Oct 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dina A Mahmoud, MBBCH (01090054328, dinaelsaman@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mullerian duct anomalies (time frame: 48 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 NCT06110052, which also lists 8 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 31 Oct 2023.