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

NCT ID: NCT07043322

Last Updated: 2025-08-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-30
• Study Completion Date: 2025-11-20

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.

Conditions

Gynecologic Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Coasting

Intervention Type: PROCEDURE

In their ICSI cycle patients will continue their agonist treatment while stopping the human menopausal gonadotropin (hMG) injections for 1 to 3 days until drop of estradiol to a safe level 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 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.

Group Type: ACTIVE_COMPARATOR

Coasting

Intervention Type: PROCEDURE

In their ICSI cycle patients will continue their agonist treatment while stopping the human menopausal gonadotropin (hMG) injections for 1 to 3 days until drop of estradiol to a safe level 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

Intervention Type: DRUG

Cabergoline is used to treat different types of medical problems that occur when too much of the hormone prolactin is produced. It can be used to treat certain menstrual problems, fertility problems in men and women, and pituitary prolactinomas

Interventions

Coasting

In their ICSI cycle patients will continue their agonist treatment while stopping the human menopausal gonadotropin (hMG) injections for 1 to 3 days until drop of estradiol to a safe level 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.

Intervention Type: PROCEDURE

Cabergoline

Cabergoline is used to treat different types of medical problems that occur when too much of the hormone prolactin is produced. It can be used to treat certain menstrual problems, fertility problems in men and women, and pituitary prolactinomas

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Mostafa Bahaa

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Mostafa Bahaa

Damietta, New Damietta, Egypt

Site Status: RECRUITING

Countries

Egypt

Facility Contacts

Mostafa Bahaa, PhD

Role: primary

mbahaa@horus.edu.eg

0201025538337

Other Identifiers

874

Identifier Type: -

Identifier Source: org_study_id