RecruitingPhase 2NCT07043322

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


Sponsor

Tanta University

Enrollment

150 participants

Start Date

Jun 30, 2025

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 20 YearsMax Age: 35 Years

Inclusion Criteria5

  • 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 Criteria2

  • 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.

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Interventions

PROCEDURECoasting

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.

DRUGCabergoline

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


Locations(1)

Mostafa Bahaa

Damietta, New Damietta, Egypt

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NCT07043322


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