Diosmin plus cabergoline for prevention of Ovarian Hyperstimulation Syndrome in high-risk women undergoing intracytoplasmic sperm injection (ICSI)

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614000535673

Enrollment

190

Registered

2014-05-20

Start date

2014-02-15

Completion date

2019-09-29

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

23 Years to 48 Years

Healthy volunteers

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

Exclusion criteria

none

Outcome results