Diosmin Versus Cabergoline for Prevention of Ovarian Hyperstimulation Syndrome

Overview

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).

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Prevention
    • Masking: Single (Participant)
  • Study Primary Completion Date: September 2015

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 eight days.

Interventions

  • Drug: Diosmin
    • 2 tab / 8 hs Diosmin ( 500mg) will be given at day of HCG injection and for14 days
  • Drug: Cabergoline
    • 1 tab/day Cabergoline( 0.5 mg) will be given at day of HCG injection and for 8 days

Arms, Groups and Cohorts

  • Active Comparator: Group A (Diosmin group)
    • In group A, (Diosmin group), 2 tab / 8 hs Diosmin ( 500mg) will be given from at day of HCG injection and for 14 days.
  • Active Comparator: Group B(Cabergoline group)
    • while in group B (Cabergoline group), 1 tab/day Cabergoline(Dostinex)( 0.5 mg) will be given at day of HCG injection and for 8 days .

Clinical Trial Outcome Measures

Primary Measures

  • Number of participants with ovarian hyperstimulation syndrome (OHSS)
    • Time Frame: every week for eight weeks
    • 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).

Secondary Measures

  • pregnancy rate
    • Time Frame: 14 days after embryos transfer
    • β-hCG (serum hCG test) will be checked 14 days after embryos transfer

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 23 Years

Maximum Age: 48 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Benha University
  • Provider of Information About this Clinical Study
    • Principal Investigator: khalid abd aziz mohamed, lecturer of ob/gyn – Benha University
  • Overall Official(s)
    • khalid mohamed, MD, Principal Investigator, Department of Obstetrics and Gynecology, Benha University Hospital
    • ahmed samy, MD, Principal Investigator, Department of Obstetrics and Gynecology, Benha University Hospital

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