Comparison of the effect of two methods of cabergoline administration to prevent ovarian hyperstimulation syndrome in women with polycystic ovary syndrome

Comparison of the effect of two cabergoline administration methods to prevent ovarian hyperstimulation syndrome (OHSS) in patients with polycystic ovary syndrome (PCO) under IVF

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20090526001952N16

Enrollment

200

Registered

2023-05-30

Start date

2023-03-01

Completion date

Unknown

Last updated

2023-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycystic ovarian syndrome. Polycystic ovarian syndrome

Interventions

Intervention 1: Intervention group1: At the same time as starting the GNRH antagonist, cabergoline 0.5 mg tablets (Aborihan Pharmaceuticals, Iran) are administered orally once a day for 15 days. Inter

Eligibility

Sex/Gender

Female

Age

18 Years to 45 Years

Inclusion criteria

Inclusion criteria: Age range of 18 to 45 years old Patients with polycystic ovary syndrome high level of anti-müllerian hormone (AMH) level (> 3 ng/ml) and/or high antral follicle count (AFC)>20

Exclusion criteria

Exclusion criteria: Allergy to cabergoline Not taking the drug completely Stopping the drug due to side effects or drug sensitivity

Design outcomes

Primary

Measure	Time frame
Ovarian hyperstimulation syndrome. Timepoint: Three days after pancture. Method of measurement: Ultrasound and clinical findings.	—

Secondary

Measure	Time frame
Checking the hematocrit level. Timepoint: Three days after ovum-pick up day. Method of measurement: 5 cc of blood is drawn in fasting state and the hematocrit level will be measured in Arash Hospital's laboratory with the (Counter SYSMEX KS-500i) device, and the device is calibrated every morning by the responsible expert.;Abdominal circumference. Timepoint: Three days after ovum-pick up day. Method of measurement: The abdominal circumference is measured at the midpoint of the line between the rib or costal margin and the iliac crest in the midaxillary line by using tape measure.;Patient’s satisfaction. Timepoint: 2 weeks after ovum-pick up day. Method of measurement: Patient satisfaction is assessed with a verbal scale of poor, satisfactory, good via telephone call.;Serum creatinine level. Timepoint: Three days after ovum-pick up day. Method of measurement: 5 cc of blood is drawn in the fasting state and and the level of serum creatinine will be measured in the laboratory of Arash hospital using the Hitachi 717 device and the Jaffe’s method.;Serum sodium and potassium levels. Timepoint: Three days after ovum-pick up day. Method of measurement: 5 cc of blood is drawn in fasting state and the serum levels of sodium and potassium will be measured in the laboratory of Arash Hospital using the Automatic Electrolyte analyzer of AUDICOM company and the ion selective electrode (ISE) method.	—

Measure

Time frame

Checking the hematocrit level. Timepoint: Three days after ovum-pick up day. Method of measurement: 5 cc of blood is drawn in fasting state and the hematocrit level will be measured in Arash Hospital's laboratory with the (Counter SYSMEX KS-500i) device, and the device is calibrated every morning by the responsible expert.;Abdominal circumference. Timepoint: Three days after ovum-pick up day. Method of measurement: The abdominal circumference is measured at the midpoint of the line between the rib or costal margin and the iliac crest in the midaxillary line by using tape measure.;Patient’s satisfaction. Timepoint: 2 weeks after ovum-pick up day. Method of measurement: Patient satisfaction is assessed with a verbal scale of poor, satisfactory, good via telephone call.;Serum creatinine level. Timepoint: Three days after ovum-pick up day. Method of measurement: 5 cc of blood is drawn in the fasting state and and the level of serum creatinine will be measured in the laboratory of Arash hospital using the Hitachi 717 device and the Jaffe’s method.;Serum sodium and potassium levels. Timepoint: Three days after ovum-pick up day. Method of measurement: 5 cc of blood is drawn in fasting state and the serum levels of sodium and potassium will be measured in the laboratory of Arash Hospital using the Automatic Electrolyte analyzer of AUDICOM company and the ion selective electrode (ISE) method.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAshraf Moini

Tehran University of Medical Sciences

hosp_arash@tums.ac.ir+98 21 7788 3283

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 5, 2026