Diosmin Versus Cabergoline for Prevention of Ovarian Hyperstimulation Syndrome

NCT02134249 | Completed Phase 2 DMC

• 1 other identifier: khalid-ahmed
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

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).

Conditions

Infertility

Keywords

infertility; ICSI; OHSS; Diosmin; Cabergoline

Outcome Measures

Primary Outcomes (1)

• Number of participants with ovarian hyperstimulation syndrome (OHSS)

  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).

  every week for eight weeks

Secondary Outcomes (1)

• pregnancy rate

  14 days after embryos transfer

Study Arms (2)

Group A (Diosmin group)

ACTIVE COMPARATOR

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

Group B(Cabergoline group)

ACTIVE COMPARATOR

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

Interventions

Diosmin DRUG

2 tab / 8 hs Diosmin ( 500mg) will be given at day of HCG injection and for14 days

Also known as: Daflon

Group A (Diosmin group)

Cabergoline DRUG

1 tab/day Cabergoline( 0.5 mg) will be given at day of HCG injection and for 8 days

Also known as: Dostinex

Group B(Cabergoline group)

Eligibility Criteria

• Age: 23 Years - 48 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Presence of more than 20 follicles by ultrasound
• E2 more than 3000 pg/ml
• Retrieval of more than 15 follicles

You may not qualify if:

• none

Sponsors & Collaborators

• Benha University: lead

Study Sites (2)

Banha Universty

Banhā, El Qalubia, 13518, Egypt

Location

Benha univesity hospital

Banhā, El Qualyobia, 13518, Egypt

Location

Related Publications (1)

• Tang H, Mourad SM, Wang A, Zhai SD, Hart RJ. Dopamine agonists for preventing ovarian hyperstimulation syndrome. Cochrane Database Syst Rev. 2021 Apr 14;4(4):CD008605. doi: 10.1002/14651858.CD008605.pub4.

  PMID: 33851429 DERIVED

MeSH Terms

Conditions

Infertility

Interventions

Diosmin; Cabergoline

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Flavones; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Ergolines; Ergot Alkaloids; Alkaloids; Heterocyclic Compounds, 4 or More Rings

Study Officials

• khalid mohamed, MD

  Department of Obstetrics and Gynecology, Benha University Hospital

  PRINCIPAL INVESTIGATOR

• ahmed samy, MD

  Department of Obstetrics and Gynecology, Benha University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of ob/gyn

Study Record Dates

• First Submitted: May 4, 2014
• First Posted: May 9, 2014
• Study Start: April 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: October 1, 2015
• Last Updated: February 2, 2016

Record last verified: 2016-01

Data Sharing

• IPD Sharing: Will share

Locations

EG (2)