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

Status: Recruiting
Location: See location...
Intervention Type: Drug, Procedure
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 20
Maximum Age: 35
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Egypt
Mostafa Bahaa
RECRUITING
Damietta
Time Frame
Start Date: 2025-06-30
Estimated Completion Date: 2025-11-20
Participants
Target number of participants: 150
Treatments
Active_comparator: Control group
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.
Active_comparator: Cabergoline group
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.
Sponsors
Leads: Tanta University

This content was sourced from clinicaltrials.gov