Actively Recruiting

Phase 2
Age: 20Years - 35Years
FEMALE
ID07043322

Clinical Study to Evaluate Efficacy of Cabergoline Compared to Coasting in Reducing Ovarian Hyperstimulation Syndrome in Women Undergoing Fertility Treatment

Led by Tanta University · Updated on 2026-03-13

150

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Ovarian hyperstimulation syndrome (OHSS) is a serious complication that can occur during controlled ovarian stimulation in stimulated ovarian cycles. It is believed to result from the release of factors like vascular endothelial growth factor, which increase capillary permeability and cause fluid to leak from blood vessels. This leads to blood thickening and complications such as increased risk of blood clots and reduced blood flow to organs. This clinical trial evaluates the effectiveness of cabergoline compared to coasting in reducing the incidence of OHSS in women undergoing ovarian stimulation. The study involves two groups: one group will receive cabergoline at a dose of 0.25 mg daily for 8 days starting from the day of HCG trigger, while the other group will undergo coasting, which means temporarily stopping human menopausal gonadotropin injections for 1 to 3 days while continuing agonist treatment until estradiol levels drop to a safer level. The coasting group may also receive cabergoline daily for 8 days in some cases. OHSS will be monitored early on the day of embryo transfer and 7 days after, with late OHSS assessed 14 days after embryo transfer. Participants will be closely monitored for OHSS occurrence and severity over one month. Assessments include hormone level measurements and follicle monitoring. The study uses a randomized, double-blind design to compare the treatments. Women aged 18 to 38 with a high risk of OHSS and specific hormone levels are eligible. Safety is monitored throughout, and the study is sponsored by Tanta University with a planned end date in November 2026.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 20Years - 35Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 38 years
  • Body mass index (BMI) less than 30 kg/m2
  • Using a long luteal protocol for ovarian stimulation
  • Day 2 FSH less than 10 mIU/L and estradiol less than 50 pg/ml
  • High risk of OHSS, defined as more than 20 follicles over 12 mm or estradiol levels over 3000 pg/ml when leading follicle is over 15 mm
Not Eligible

You will not qualify if you...

  • Presence of chronic medical diseases such as liver failure, kidney failure, uncontrolled hypertension, uncontrolled diabetes, or severe heart disease (class 3 or 4)
  • Allergy to cabergoline

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - Approximately 2 weeks covering ovarian stimulation, HCG triggering, and treatment period

Participants undergo ovarian stimulation with interventions to reduce risk of ovarian hyperstimulation syndrome (OHSS). Depending on their group, they receive either cabergoline daily for 8 days starting on HCG triggering day, or coasting for 1 to 3 days plus cabergoline for 8 days from HCG triggering day.

Multiple visits during ovarian stimulation and treatment including HCG triggering day and embryo transfer

Follow-up

Duration - 14 days after embryo transfer

Participants are monitored for occurrence and severity of early and late OHSS after embryo transfer.

3 visits: day of embryo transfer, 7 days after embryo transfer, and 14 days after embryo transfer

Trial Site Locations

Total: 1 location

1

Mostafa Bahaa

Damietta, New Damietta, Egypt, 34518

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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