Diosmin Versus Cabergoline for Prevention of Ovarian Hyperstimulation Syndrome
Information source: Benha University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Infertility
Intervention: Diosmin (Drug); Cabergoline (Drug)
Phase: Phase 2/Phase 3
Status: Completed
Sponsored by: Benha University Official(s) and/or principal investigator(s):
khalid mohamed, MD, Principal Investigator, Affiliation: Department of Obstetrics and Gynecology, Benha University Hospital
ahmed samy, MD, Principal Investigator, Affiliation: Department of Obstetrics and Gynecology, Benha University Hospital
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).
Clinical Details
Official title: Diosmin Versus Cabergoline for Prevention of Ovarian Hyperstimulation Syndrome
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
Primary outcome: Number of participants with ovarian hyperstimulation syndrome (OHSS)
Secondary outcome: pregnancy rate
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 2 weeks.
Eligibility
Minimum age: 23 Years.
Maximum age: 48 Years.
Gender(s): Female.
Criteria:
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
Locations and Contacts
Benha univesity hospital, Benha, El Qualyobia 13518, Egypt
Additional Information
Starting date: April 2014
Last updated: May 10, 2015
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