RecruitingPhase 3ACTRN12614000535673

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


Sponsor

khalid abd aziz mohamed

Enrollment

250 participants

Start Date

Feb 15, 2014

Study Type

Interventional

Conditions

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.


Eligibility

Sex: FemalesMin Age: 23 YearssMax Age: 48 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding a medication called Diosmin — usually used to treat vein problems — to standard treatment can help prevent ovarian hyperstimulation syndrome (OHSS) in women undergoing fertility treatment (ICSI). OHSS is a potentially serious complication of fertility treatment where the ovaries become swollen and painful. Women at high risk of OHSS will be randomly assigned to receive either Diosmin plus cabergoline, or cabergoline alone. You may be eligible if: - You are a woman between 23 and 48 years old - You are undergoing intracytoplasmic sperm injection (ICSI) fertility treatment - You have signs of being at high risk for OHSS (more than 20 follicles on ultrasound, high estrogen level, or more than 15 eggs retrieved) - You have infertility, with or without polycystic ovary syndrome (PCOS) You may NOT be eligible if: - There are no listed exclusion criteria for this study Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 inje

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


Locations(1)

Benha city, Egypt

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ACTRN12614000535673