Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000535673
Ethics application status
Approved
Date submitted
1/05/2014
Date registered
20/05/2014
Date last updated
16/09/2019
Date data sharing statement initially provided
16/09/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Diosmin plus cabergoline for prevention of Ovarian Hyperstimulation Syndrome in high-risk women undergoing intracytoplasmic sperm injection (ICSI)
Scientific title
Diosmin plus cabergoline for prevention of Ovarian Hyperstimulation Syndrome in high-risk women undergoing intracytoplasmic sperm injection (ICSI)
Secondary ID [1] 284517 0
none
Universal Trial Number (UTN)
U1111-1154-6638
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
infertile women 291775 0
Ovarian Hyperstimulation Syndrome 291828 0
PCO (polycystic ovarian syndrome) 291829 0
Condition category
Condition code
Reproductive Health and Childbirth 292140 292140 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
n group A, (Diosmin group), 2 tablets every 8 hours Diosmin ( 500mg) will be given from the day of ovum retrieval and for 14 days plus 1 tab/day Cabergoline ( 0.5 mg) will be given at day of HCG injection and for eight days.
all patient returned her empty medications boxes to ensure they are taking medications
Intervention code [1] 289278 0
Prevention
Intervention code [2] 289332 0
Treatment: Drugs
Comparator / control treatment
in group B, 1 tab/day Cabergoline ( 0.5 mg) will be given at day of HCG injection and for eight days.
Control group
Active

Outcomes
Primary outcome [1] 292016 0
Occurrence of ovarian hyperstimulation syndrome(OHSS)
will be assessed :
A. Clinically:
1. Abdominal bloating
2. Mild abdominal pain
3. Nausea +/- vomiting
4. Oliguria
5. Acute respiratory distress syndrome
B. By ultrasound
1. Ovarian size usually greater than 8 cm
2. Ultrasound evidence of ascites
C. Laboratory
1. haematocrit greater than 45%
2. Hypoproteinaemia
Timepoint [1] 292016 0
will be assessed every two weeks after retrieval and for 8 weeks
Secondary outcome [1] 308003 0
the pregnancy rate

will be assessed by :serum hCG test
Timepoint [1] 308003 0
Beta sub-unit of hCG (serum hCG test)
was checked 16 days after embryos transfer

Eligibility
Key inclusion criteria
infertile women with or without polcystic ovarian syndrome and candidate forICSI with one of the following:

1. Presence of more than 20 follicles by ultrasound
2. E2 more than 3000 pg/ml
3. Retrieval of more than 15 follicles
Minimum age
23 Years
Maximum age
48 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
none

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
two hundred women at risk of ovarian hyperstimulation syndrome during ICSI cycles will be randomly scheduled into two equal groups. In group A(100 patients), (Diosmin group), 2 tab every 8 hs Diosmin ( 500mg) will be given from the day of ovum retrieval and for 14 days plus 1 tab/day Cabergoline( 0.5 mg) will be given at day of HCG injection and for eight days. ; while in group B (100 patients) (control group) 1 tab/day Cabergoline( 0.5 mg) will be given at day of HCG injection and for eight days.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
odd-numbered patients (group A) will receive 2 tab every 8 hs Diosmin (500mg)(Daflon) will be given from the day of ovum retrieval and for 14 days plus 1 tab/day Cabergoline( 0.5 mg) will be given at day of HCG injection and for eight days.;
while even-numbered patients (group B) (control group) will recieve 1 tab/day Cabergoline( 0.5 mg) will be given at day of HCG injection and for eight days.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Data obtained will be statistically analyzed using The Statistical Package for Social Sciences (SPSS, Chicago, USA) software version 15.0 for Windows. Results will be expressed as mean +/- SD, numbers and percentages. Means will be compared using the paired student’s t test while categorical data will be compared using the chi-square test with Yates' continuity correction. A p value of less than 0.05 is considered statistically significant

sample size calculation is according to the following formula:

N = 2Standard deviation X K / E2


*Standard deviation: population of previous literature
*K : constant (7.8) from statistical table
*E2: minimal change in mean that would be clinical

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
13/02/2014
Actual
15/02/2014
Date of last participant enrolment
Anticipated
29/09/2019
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
250
Accrual to date
190
Final
Recruitment outside Australia
Country [1] 6026 0
Egypt
State/province [1] 6026 0
Benha city

Funding & Sponsors
Funding source category [1] 289157 0
Self funded/Unfunded
Name [1] 289157 0
Ahmed samy saad
Country [1] 289157 0
Egypt
Funding source category [2] 289188 0
Self funded/Unfunded
Name [2] 289188 0
khalid abd aziz mohamed
Country [2] 289188 0
Egypt
Primary sponsor type
Individual
Name
khalid abd aziz mohamed
Address
Benha University, Faculty of Medicine
el saha street
Benha city
Qalubiya Governorate
Egypt
13518
Country
Egypt
Secondary sponsor category [1] 287822 0
Individual
Name [1] 287822 0
Ahmed samy saad
Address [1] 287822 0
Benha University, Faculty of Medicine
el saha street
Benha city
Qalubiya Governorate
Egypt
13518
Country [1] 287822 0
Egypt

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290930 0
local ethical committe of Department of Obstetrics and Gynecology, Benha University Hospitals
Ethics committee address [1] 290930 0
Benha University, Faculty of Medicine el saha street Benha city Qalubiya Governorate Egypt 13518
Ethics committee country [1] 290930 0
Egypt
Date submitted for ethics approval [1] 290930 0
15/02/2014
Approval date [1] 290930 0
15/02/2014
Ethics approval number [1] 290930 0

Summary
Brief summary
Objectives: To assess the effecacy of oral Diosmin in the prevention of ovarian hyperstimulation syndrome (OHSS) in high-risk women underwent intracytoplasmic sperm injection (ICSI).
Study design: Prospective randomized controlled clinical trial.
Patients and Methods: two hundred women at risk of ovarian hyperstimulation syndrome during ICSI cycles will be randomly scheduled into two equal groups. In group A, (Diosmin group), 2 tab every 8 hs Diosmin ( 500mg) plus 1 tab/day Cabergoline( 0.5 mg) will be given at day of HCG injection .; while in group B (control group), 1 tab/day Cabergoline( 0.5 mg) will be given at day of HCG injection and for eight days. The main outcome measures were rates and grades of OHSS, and the pregnancy rate in both groups.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 48030 0
Dr khalid abd aziz mohamed
Address 48030 0
Benha University, Faculty of Medicine
el saha street
Benha city
Qalubiya Governorate
Egypt
13518
Country 48030 0
Egypt
Phone 48030 0
+201281469651
Fax 48030 0
Email 48030 0
[email protected]
Contact person for public queries
Name 48031 0
Dr ahmed samy saad
Address 48031 0
Benha University, Faculty of Medicine
el saha street
Benha city
Qalubiya Governorate
Egypt
13518
Country 48031 0
Egypt
Phone 48031 0
+201281469651
Fax 48031 0
Email 48031 0
[email protected]
Contact person for scientific queries
Name 48032 0
Dr khalid abd aziz mohamed
Address 48032 0
Benha University, Faculty of Medicine
el saha street
Benha city
Qalubiya Governorate
Egypt
13518
Country 48032 0
Egypt
Phone 48032 0
+201281469651
Fax 48032 0
Email 48032 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.