Diosmin Versus Cabergoline for Prevention of Ovarian Hyperstimulation Syndrome (infertility)

Benha University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Infertility

Treatments: Drug: Diosmin; Drug: Cabergoline

Study type: Interventional

Funder types: Other

Identifiers

NCT02134249

khalid-ahmed

Details and patient eligibility

About

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).

Full 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.

Enrollment: 200 patients

Sex: Female

Ages: 23 to 48 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

---

200 participants in 2 patient groups

Group A (Diosmin group)

Active Comparator group

Description:

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

Treatment:

Drug: Diosmin

Group B(Cabergoline group)

Active Comparator group

Description:

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 .

Treatment:

Drug: Cabergoline