Calcium Dobesilate Versus Cabergoline for Prevention of Ovarian Hyperstimulation Syndrome

Sponsor

Benha University (Other)

Overall Status

Completed

CT.gov ID

NCT02271360

Collaborator

(none)

200

Enrollment

Location

Arms

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Infertility	Drug: Calcium Dobesilate Drug: Cabergoline	Phase 2/Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Prevention

Official Title:

Calcium Dobesilate Versus Cabergoline for Prevention of Ovarian Hyperstimulation Syndrome

Actual Study Start Date :

Apr 1, 2014

Actual Primary Completion Date :

Dec 1, 2015

Actual Study Completion Date :

Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: group A 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.	Drug: Calcium Dobesilate 1 cap / 8 hs Calcium Dobesilate ( 500mg) will be given at day of HCG injection and for 21 days Other Names: doxium
Active Comparator: group B 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 .	Drug: Cabergoline 1 tab/day Cabergoline( 0.5 mg) will be given at day of HCG injection and for 8 days Other Names: Dostinex

Arm

Intervention/Treatment

Active Comparator: group A

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.

Drug: Calcium Dobesilate

1 cap / 8 hs Calcium Dobesilate ( 500mg) will be given at day of HCG injection and for 21 days

Other Names:

doxium

Active Comparator: group B

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 .

Drug: Cabergoline

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

Other Names:

Dostinex

Outcome Measures

Primary Outcome Measures

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

pregnancy rate [14 days after embryos transfer]
β-hCG (serum hCG test) will be checked 14 days after embryos transfer

Eligibility Criteria

Criteria

Ages Eligible for Study:

22 Years to 44 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Patients enrolled in the study were infertile women undergoing ICSI with one of the following criteria: previous episodes of OHSS, polycystic ovaries (i.e., > 24 antral follicles present on baseline ultrasound examination), high AMH (> 3.0 ng/mL), large number of small follicles (8 to 12 mm) seen on ultrasound during ovarian stimulation, high s.E2 at hCG trigger (E2 >3000 pg/ml or rapidly rising s.E2), presence of > 20 follicles by ultrasound on day of retrieval or large number of oocytes retrieved (> 20).