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

Not Applicable

Not yet recruiting

• Conditions: Gynecologic Disease
• Interventions: Procedure: Coasting; Drug: Cabergoline

• Registration Number: NCT07043322
• Lead Sponsor: Tanta University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-21
• Study First Submitted QC: 2025-06-21
• Last Update Submitted: 2025-06-21
• Study First Posted: 2025-06-29
• Last Update Posted: 2025-06-29
• Study Start: 2025-06-30
• Primary Completion: 2025-10-20
• Study Completion: 2025-11-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Coasting	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.
Cabergoline group	Coasting	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.
Cabergoline group	Cabergoline	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.

Primary Outcome Measures

Name	Time	Method
Occurrence and severity of OHSS	1 month	The primary outcome of this study is the occurrence and severity of OHSS. OHSS was defined as abdominal pain and distention associated with nausea and vomiting and ovarian enlargement \> 8 cm. The severity of OHSS will be assessed (mild, moderate, severe, and clinical) according to the American Society for Reproductive Medicine guidelines