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

Phase 2RecruitingNCT07043322

Tanta University150 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

150

Conditions

Gynecologic Disease

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.

CabergolineDRUG

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

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 35 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Time frame: 1 month