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Diosmin Versus Cabergoline for Prevention of Ovarian Hyperstimulation Syndrome (infertility)

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ClinicalTrials.gov Identifier: NCT02134249
Recruitment Status : Completed
First Posted : May 9, 2014
Last Update Posted : February 2, 2016
Sponsor:
Information provided by (Responsible Party):
khalid abd aziz mohamed, Benha University

Brief 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).

Condition or disease Intervention/treatment Phase
Infertility Drug: Diosmin Drug: Cabergoline Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Diosmin Versus Cabergoline for Prevention of Ovarian Hyperstimulation Syndrome
Study Start Date : April 2014
Actual Primary Completion Date : September 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility

Arm Intervention/treatment
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.
Drug: Diosmin
2 tab / 8 hs Diosmin ( 500mg) will be given at day of HCG injection and for14 days
Other Name: Daflon

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 .
Drug: Cabergoline
1 tab/day Cabergoline( 0.5 mg) will be given at day of HCG injection and for 8 days
Other Name: Dostinex




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. pregnancy rate [ Time Frame: 14 days after embryos transfer ]
    β-hCG (serum hCG test) will be checked 14 days after embryos transfer



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Ages Eligible for Study:   23 Years to 48 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02134249


Locations
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Egypt
Banha Universty
Banha, El Qalubia, Egypt, 13518
Benha univesity hospital
Benha, El Qualyobia, Egypt, 13518
Sponsors and Collaborators
Benha University
Investigators
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Principal Investigator: khalid mohamed, MD Department of Obstetrics and Gynecology, Benha University Hospital
Principal Investigator: ahmed samy, MD Department of Obstetrics and Gynecology, Benha University Hospital

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Responsible Party: khalid abd aziz mohamed, lecturer of ob/gyn, Benha University
ClinicalTrials.gov Identifier: NCT02134249     History of Changes
Other Study ID Numbers: khalid-ahmed
First Posted: May 9, 2014    Key Record Dates
Last Update Posted: February 2, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: with other researcher on research gate
Keywords provided by khalid abd aziz mohamed, Benha University:
infertility
ICSI
OHSS
Diosmin
Cabergoline
Additional relevant MeSH terms:
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Ovarian Hyperstimulation Syndrome
Ovarian Diseases
Infertility
Genital Diseases, Male
Genital Diseases, Female
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases
Cabergoline
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs