Diosmin Versus Cabergoline for Prevention of Ovarian Hyperstimulation Syndrome

Phase 2

Completed

• Conditions: Infertility
• Interventions: Drug: Diosmin; Drug: Cabergoline

• Registration Number: NCT02134249
• Lead Sponsor: 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).

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.

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-05-04
• Study First Submitted QC: 2014-05-08
• Study First Posted: 2014-05-09
• Primary Completion: 2015-09
• Study Completion: 2015-10
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-29
• Last Update Posted: 2016-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group A (Diosmin group)	Diosmin	In group A, (Diosmin group), 2 tab / 8 hs Diosmin ( 500mg) will be given from at day of HCG injection and for 14 days.
Group B(Cabergoline group)	Cabergoline	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 .

Primary Outcome Measures

Name	Time	Method
Number of participants with ovarian hyperstimulation syndrome (OHSS)	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

Name	Time	Method
pregnancy rate	14 days after embryos transfer	β-hCG (serum hCG test) will be checked 14 days after embryos transfer

Trial Locations

Locations (2)

Banha Universty; 🇪🇬 Banha, El Qalubia, Egypt

Benha univesity hospital; 🇪🇬 Benha, El Qualyobia, Egypt