Clinical Study to Evaluate Efficacy of Cabergoline to Coasting in Reducing the Incidence of Ovarian Hyperstimulation Syndrome

Tanta University

Status and phase: Enrolling; Phase 2

Conditions: Gynecologic Disease

Treatments: Procedure: Coasting; Drug: Cabergoline

Study type: Interventional

Funder types: Other

Identifiers

NCT07043322

874

Details and patient eligibility

About

Ovarian hyperstimulation syndrome (OHSS) is a serious iatrogenic complication of controlled ovarian stimulation of gonadotrophin-Stimulated ovarian cycles. It is theorized to manifest systemically as a result of vasoactive mediators like vascular endothelium growth factor (VEGF) being released from hyperstimulated ovaries. As a result, capillary permeability is increased which causes the extravasation of fluid from the intravascular compartment into the third space. The haemoconcentration which ensues results in complications such as hypercoagulability and reduced end organ perfusion.

Enrollment: 150 estimated patients

Sex: Female

Ages: 20 to 35 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age between 18-38 years
• Body mass index (calculated as weight in kilograms divided by the square of height in meters) < 30 kg/m2.
• A long luteal protocol is used for ovarian stimulation.
• Day 2 FSH <10 mIU/L and E2< 50 pg/ml
• High risk of OHSS, defined as having more than 20 follicles >12 mm in diameter and/or E2 levels > 3000 pg/ml when the size of the leading follicle is > 15 mm

Exclusion criteria

The presence of chronic medical diseases, including liver cell failure, renal failure, uncontrolled hypertension, uncontrolled diabetes mellitus, or class 3 or 4 function heart disease in the New York heart association classification.

Allergy to Cabergoline.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 2 patient groups

Control group

Active Comparator group

Description:

Group 1 (coasting only): In their ICSI cycle patients will take 0.25 mg of cabergoline daily for 8 days from HCG triggering day to prevent OHSS. Early OHSS is assessed at day of embryo transfer and 7 days after this date. Late OHSS is assessed 14 days after embryo transfer.

Treatment:

Procedure: Coasting

Cabergoline group

Active Comparator group

Description:

Coasting plus cabergoline: In their ICSI cycle patients will continue their agonist treatment while stopping the human menopausal gonadotropin (hMG) injections for 1 day plus receiving 0.25 mg of cabergoline daily for 8 days from HCG triggering day to prevent OHSS. Early OHSS is assessed at day of embryo transfer and 7 days after this date. Late OHSS is assessed 14 days after embryo transfer.

Treatment:

Drug: Cabergoline

Procedure: Coasting