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

Inclusion Criteria4

  • infertile women with or without polcystic ovarian syndrome and candidate forICSI with one of the following:
  • Presence of more than 20 follicles by ultrasound
  • E2 more than 3000 pg/ml
  • Retrieval of more than 15 follicles

Exclusion Criteria1

  • none

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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