Diosmin Versus Cabergoline for Prevention of Ovarian Hyperstimulation Syndrome (infertility)
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|ClinicalTrials.gov Identifier: NCT02134249|
Recruitment Status : Completed
First Posted : May 9, 2014
Last Update Posted : February 2, 2016
|Condition or disease||Intervention/treatment||Phase|
|Infertility||Drug: Diosmin Drug: Cabergoline||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||Diosmin Versus Cabergoline for Prevention of Ovarian Hyperstimulation Syndrome|
|Study Start Date :||April 2014|
|Actual Primary Completion Date :||September 2015|
|Actual Study Completion Date :||October 2015|
Active Comparator: Group A (Diosmin group)
In group A, (Diosmin group), 2 tab / 8 hs Diosmin ( 500mg) will be given from at day of HCG injection and for 14 days.
2 tab / 8 hs Diosmin ( 500mg) will be given at day of HCG injection and for14 days
Other Name: Daflon
Active Comparator: Group B(Cabergoline group)
while in group B (Cabergoline group), 1 tab/day Cabergoline(Dostinex)( 0.5 mg) will be given at day of HCG injection and for 8 days .
1 tab/day Cabergoline( 0.5 mg) will be given at day of HCG injection and for 8 days
Other Name: Dostinex
- Number of participants with ovarian hyperstimulation syndrome (OHSS) [ Time Frame: every week for eight weeks ]Diagnosis of OHSS was made according to the criteria of Golan et al.. Mild OHSS was classified as: Grade 1 (abdominal distension and discomfort) and Grade 2 (features of grade 1 plus nausea, vomiting and/or diarrhea; ovaries are enlarged from 5 to 12 cm), moderate OHSS as Grade 3 (features of mild OHSS plus ultrasonic evidence of ascites), severe OHSS as Grade 4 (features of moderate OHSS plus evidence of ascites and/or hydrothorax and breathing difficulties) and Grade 5 (all of the above, plus change in the blood volume, increased blood viscosity due to hemoconcentration, coagulation abnormality, and diminished renal perfusion and function).
- pregnancy rate [ Time Frame: 14 days after embryos transfer ]β-hCG (serum hCG test) will be checked 14 days after embryos transfer
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02134249
|Banha, El Qalubia, Egypt, 13518|
|Benha univesity hospital|
|Benha, El Qualyobia, Egypt, 13518|
|Principal Investigator:||khalid mohamed, MD||Department of Obstetrics and Gynecology, Benha University Hospital|
|Principal Investigator:||ahmed samy, MD||Department of Obstetrics and Gynecology, Benha University Hospital|