Diosmin Versus Cabergoline for Prevention of Ovarian Hyperstimulation Syndrome

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the effect of oral Diosmin to oral Cabergoline in the prevention of ovarian hyperstimulation syndrome (OHSS) in high-risk women underwent intracytoplasmic sperm injection (ICSI).

Detailed Description
-----------------
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 / 8 hs Diosmin ( 500mg) will be given at day of HCG injection and for 2 weeks ; while in group B (Cabergoline group), 1 tab/day Cabergoline( 0.5 mg) will be given at day of HCG injection and for eight days.

Official Title
-----------------
Diosmin Versus Cabergoline for Prevention of Ovarian Hyperstimulation Syndrome

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Drug: Diosmin
* Drug: Cabergoline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: infertile women undergoing intracytoplasmic sperm injection or polycystic ovarin syndrome (PCO) with one of the following: Presence of more than 20 follicles by ultrasound E2 more than 3000 pg/ml Retrieval of more than 15 follicles Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 23 Years
Maximum Age: 48 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A (Diosmin group)<br>In group A, (Diosmin group), 2 tab / 8 hs Diosmin ( 500mg) will be given from at day of HCG injection and for 14 days. | Drug: Diosmin<br>* 2 tab / 8 hs Diosmin ( 500mg) will be given at day of HCG injection and for14 days<br>* Other names: Daflon;|
| Active Comparator: Group B(Cabergoline group)<br>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 . | Drug: Cabergoline<br>* 1 tab/day Cabergoline( 0.5 mg) will be given at day of HCG injection and for 8 days<br>* Other names: Dostinex;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with ovarian hyperstimulation syndrome (OHSS) | 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). | every week for eight weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pregnancy rate | β-hCG (serum hCG test) will be checked 14 days after embryos transfer | 14 days after embryos transfer | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diosmin, infertility, ICSI, OHSS, Cabergoline