Calcium Dobesilate Versus Cabergoline for Prevention of Ovarian Hyperstimulation Syndrome

Benha University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Infertility

Treatments: Drug: Calcium Dobesilate; Drug: Cabergoline

Study type: Interventional

Funder types: Other

Identifiers

NCT02271360

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Details and patient eligibility

About

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).

Full 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.

Enrollment: 200 patients

Sex: Female

Ages: 22 to 44 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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).

Exclusion Criteria:

• None

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

group A

Active Comparator group

Description:

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.

Treatment:

Drug: Calcium Dobesilate

group B

Active Comparator group

Description:

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 .

Treatment:

Drug: Cabergoline