Infertility
Conditions
Keywords
infertility, ICSI, OHSS, Diosmin, Cabergoline
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.
Interventions
DRUGDiosmin
2 tab / 8 hs Diosmin ( 500mg) will be given at day of HCG injection and for14 days
DRUGCabergoline
1 tab/day Cabergoline( 0.5 mg) will be given at day of HCG injection and for 8 days
Sponsors
Benha University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
23 Years to 48 Years
Healthy volunteers
No
Inclusion criteria
infertile women undergoing intracytoplasmic sperm injection or polycystic ovarin syndrome (PCO) 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
Exclusion criteria
* none
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with ovarian hyperstimulation syndrome (OHSS) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| pregnancy rate | 14 days after embryos transfer | β-hCG (serum hCG test) will be checked 14 days after embryos transfer |
Countries
Egypt
Outcome results
None listed