Calcium Dobesilate Versus Cabergoline for Prevention of Ovarian Hyperstimulation Syndrome

Phase 2

Completed

• Conditions: Infertility
• Interventions: Drug: Calcium Dobesilate; Drug: Cabergoline

• Registration Number: NCT02271360
• Lead Sponsor: Benha University

Brief Summary

The purpose of this study is to compare the effect of oral Calcium Dobesilate to oral Cabergoline in the prevention of ovarian hyperstimulation syndrome (OHSS) in high-risk women underwent intracytoplasmic sperm injection (ICSI).

Detailed Description

Two hundred and twenty women at risk of ovarian hyperstimulation syndrome during ICSI cycles will be randomly scheduled into two equal groups. In group A, (Calcium Dobesilate group), 1 cap / 8 hs Doxium ( 500mg) will be given at day of HCG injection and for 21 days; while in group B (Cabergoline group), 1 tab/day Cabergoline( 0.5 mg) will be given at day of HCG injection and for 8 days.

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-10-19
• Study First Submitted QC: 2014-10-21
• Study First Posted: 2014-10-22
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-14
• Last Update Posted: 2017-02-16

Recruitment & Eligibility

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

Inclusion Criteria

Not provided

Exclusion Criteria

• None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group A	Calcium Dobesilate	In group A, (Calcium Dobesilate group), 1 cap / 8 hs Calcium Dobesilate ( 500mg) will be given from at day of HCG injection and for 21 days.
group B	Cabergoline	while in group B (Cabergoline group), 1 tab/day Cabergoline(Dostinex)( 0.5 mg) will be givenat day of HCG injection and for 8 days .

Primary Outcome Measures

Name	Time	Method
Number of participants with ovarian hyperstimulation syndrome (OHSS)	weekly for eight weeks	this will be assessed by: Clinically: Abdominal bloating Mild abdominal pain Nausea ± vomiting Oliguria Acute respiratory distress syndrome; By ultrasound Ovarian size usually ˃8 cm Ultrasound evidence of ascites; Laboratory Haemoconcentration haematocrit ˃45% Hypoproteinaemia

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 (1)

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