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

NCT07043322 | Recruiting Phase 2

• 1 other identifier: 874
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Occurrence and severity of OHSS

  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

  1 month

Study Arms (2)

Control group

ACTIVE COMPARATOR

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.

Procedure: Coasting

Cabergoline group

ACTIVE COMPARATOR

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.

Procedure: Coasting; Drug: Cabergoline

Interventions

Coasting 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; Control group

Cabergoline 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

Cabergoline group

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Mostafa Bahaa

Damietta, New Damietta, 34518, Egypt

RECRUITING

MeSH Terms

Conditions

Genital Diseases, Female

Interventions

Cabergoline

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Ergolines; Ergot Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: June 21, 2025
• First Posted: June 29, 2025
• Study Start: June 30, 2025
• Primary Completion (Estimated): October 20, 2026
• Study Completion (Estimated): November 20, 2026
• Last Updated: March 13, 2026

Record last verified: 2026-03

Locations

EG (1)