An interventional study of sclerotherapy in Benign Ovarian Cyst, sponsored by Al-Azhar University. Completed at 1 site in Egypt. Open to female participants aged 15 Years to 48 Years. Per ClinicalTrials.gov, last updated 2024-05-06.
Sponsored by Al-Azhar University · Not applicable, Interventional, and Treatment
Among 10 studies in Ovarian Cysts with a site in Egypt — 2 open to participants now, 2 under way, none of them phase 3. Ovarian Cysts · Egypt.
Among the 10 studies in Ovarian Cysts with a site in Egypt, this one is one of 2 that started in 2022, is one of 8 with no phase, and was the 6th registered.
80 studies on the registry are indexed under Ovarian Cysts; 16 are open to participants now.
Browse Ovarian Cysts studies →2 of the 10 studies in Ovarian Cysts with a site in Egypt are open now. Recruiting first, the newest first:
Benha University · Sites in Egypt
Ages 18–45 · Women only
Kafrelsheikh University · Sites in Egypt
Ages 18–50 · Women only
A study can be open while its sites in Egypt have not opened yet or have stopped. Only those recruiting at a site in Egypt →
Of the 12 Ovarian Cysts studies recruiting now, 4 (33%) set no upper age limit and 7 (58%) stop at 75 or younger; 3 take children under 18; 3 take healthy volunteers.
This study: 15 Years to 48 Years · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
10 studies; the count open now beside each. This study's row is marked.
First in 2017; this study’s year is marked. 2 started in 2022.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 52 is below the median of 74 across 51 interventional studies indexed under Ovarian Cysts.
Median enrollment 79 across the 9 interventional studies, 1,000 across the 1 observational. Of the 4 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
None of the 10 has an industry lead sponsor. The 8 most frequent:
Al-Azhar University is the lead sponsor of 531 studies on the registry; 172 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Al-Azhar University has 2 studies filed under Ovarian Cysts — fewer than ten, so there is no comparison to draw.
1 of the studies in Ovarian Cysts with a site in Egypt that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07686783Benha UniversityOvarian Reserve After Laparoscopic Cystectomy for Endometriotic and Non-Endometriotic Cysts | 2027-06 |
Among the 10 studies in Ovarian Cysts with a site in Egypt, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The aim of this study was to evaluate the role of sclerotherapy (injection of tetracycline or injection of Polidocanol - 95% hydroxypolyethoxydodecane and 5% ethanol -) in treatment of non-neoplastic ovarian cysts by, percutaneous trans-abdominal approach or trans-vaginal approach.
Ovarian cysts are fluid-filled sacs that form in or on an ovary. Such cysts are relatively common. Most are non-cancerous (benign) and disappear on their own. Ovarian cancer is more likely to occur in women over 50.
Most of the patients with ovarian cyst are symptomless and resolves spontaneously. If untreated, complications such as rupture, torsion, malignant transformation may occur.
Cyst rupture can lead to peritoneal signs, abdominal distension and bleeding, irregularity of the menstrual cycle and abnormal vaginal bleeding, dull bilateral pelvic pain may result from the lutein cysts.
Until recent times, surgery in the form of laparotomy or laparoscopy has been the first choice. However, ultrasonography guided aspiration of the cysts as an alternative treatment is the fast catching up and may even be procedure of choice in the management of ovarian cysts in a selected group of women as it has low recurrence rate, low risk, less cost and in most cases no hospital stay.
There are various types of ovarian cysts, such as functional cysts, follicular cysts, corpus luteum cysts, hemorrhagic cysts, theca-lutein cysts, peritoneal inclusion cysts or pseudo-cysts, polycystic ovaries and endometriomas.
Functional cysts do not regress when treated with combined oral contraceptives that they do with expectant management.
Ovarian cysts are common, affecting 20% of women at some point in their lives . Unlike unilocular cysts including septations, solid irregular wall, or internal plaques, the simple ovarian cyst is defined as an anechoic round or oval lesion. The maximum diameter of simple ovarian cysts in premenopausal women is less than 5 cm, they often disappear during the menstrual cycle and do not require further intervention. Larger cysts (5-7 cm) should be followed using ultrasonography. Cysts larger than 7 cm may require advanced imaging or surgery.
Differential diagnosis in the management of an adnexal mass is complex because of the scope of the disorders that may have caused it and the numerous therapies that may be appropriate. It is the risk of malignancy that propels protocols and procedures, as well as the fundamental concept that early diagnosis and treatment in cancer are related to lesser mortality and morbidity. Non neoplastic ovarian cysts in women with menstrual cycles are the most frequently detected masses involving the adnexa. Many of these cysts are functional and resolve spontaneously within a few days to 2 weeks, but they can persist longer.
The management of women with benign ovarian cysts remains controversial. Various treatment protocols use medical treatment (mainly oral contraceptives), ultrasound-guided aspiration, laparoscopy (cystectomy or drainage and ablation of the cystic wall) and laparotomy (cystectomy) Sclerotherapy of ovarian cysts has been attempted to decrease the probability of recurrence. Although ultrasound-guided aspiration is simple and safe, the recurrence rate is high, ranging from 28.5% to 100%. In order to reduce this rate, ultrasound-guided ethanol sclerotherapy for ovarian cysts was first introduced in 1988, and it has been reported by several authors to be simple and safe.
Tetracycline, methotrexate, and ethanol are the most common agents used for sclerotherapy. When compared to women without cysts, sclerotherapy applied to infertile women with ovarian cysts has been shown to reduce pelvic pain without affecting the number of follicles, term pregnancy and abortion rates, the number of obtained oocytes, embryo quality, or hormonal levels.
We chose either tetracycline or Polidocanol as sclerosing agents. Tetracycline because of its antibacterial effect, which may help to control infections. Tetracyclines (tetracycline, doxycycline, minocycline) have been used as sclerosing agent in various clinical settings such as pleural effusions, pneumothoraxes, hydroceles, benign lymphoepithelial cysts of the parotid gland and lymphoceles after renal transplantation.
Polidocanol is a nonionic surfactant sclerosing agent, which consists of 95% hydroxypolyethoxydodecane and 5% ethanol. Polidocanol was invented as an anesthetic agent. Polidocanol is a liquid surfactant having endothelial cell lytic properties.
The mechanism underlying the sclerosing effect was generally attributed to the results of local chemical irritation or inflammatory response. Ethanol induces a combination of cytotoxic damage, dehydration of cells, and production of mediators for inflammation and fibrosis.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure: sclerotherapy
Procedure: sclerotherapy
injection of sclerosing agent (tetracycline or polidocanol) into ovarian cyst after aspiration of its contents
role of sclerotherapy in treatment of non-neoplastic ovarian cysts
The main outcome measure was the disappearance of the cyst and the avoidance of surgery. The cyst was considered resolved if follow-up revealed either no cystic lesion or only a follicle-like cyst no more than 30 mm in diameter.
Time frame: followed up from 1 month to 6 months
Ran from Sep 2022 to primary completion in Jan 2024, 16 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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