infertility: Diosmin Versus Cabergoline for Prevention of Ovarian Hyperstimulation Syndrome

Sponsor

Benha University (Other)

Overall Status

Completed

CT.gov ID

NCT02134249

Collaborator

(none)

200

Enrollment

Locations

Arms

Duration (Months)

100

Patients Per Site

5.6

Patients Per Site Per Month

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

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 :

Apr 1, 2014

Actual Primary Completion Date :

Sep 1, 2015

Actual Study Completion Date :

Oct 1, 2015

Arms and Interventions

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 Names: 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 Names: Dostinex

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 Names:

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 Names:

Dostinex

Outcome Measures

Primary Outcome Measures

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

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:

23 Years to 48 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria: infertile women undergoing intracytoplasmic sperm injection or polycystic ovarin syndrome (PCO) with one of the following:

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

Exclusion Criteria:

none

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Banha Universty	Banha	El Qalubia	Egypt	13518
2	Benha univesity hospital	Benha	El Qualyobia	Egypt	13518

Sponsors and Collaborators

Benha University

Investigators

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