Infertility Clinical Trial
— infertilityOfficial title:
Diosmin Versus Cabergoline for Prevention of Ovarian Hyperstimulation Syndrome
Verified date | January 2016 |
Source | Benha University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Egypt: Ministry of Higher Education |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 200 |
Est. completion date | October 2015 |
Est. primary completion date | September 2015 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 23 Years to 48 Years |
Eligibility |
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: |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Egypt | Banha Universty | Banha | El Qalubia |
Egypt | Benha univesity hospital | Benha | El Qualyobia |
Lead Sponsor | Collaborator |
---|---|
Benha University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Yes |
Secondary | pregnancy rate | ß-hCG (serum hCG test) will be checked 14 days after embryos transfer | 14 days after embryos transfer | Yes |
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