Compare the Efficacy of Human Albumin With Cabergoline to Prevent Ovarian Hyper Stimulation in Assisted Reproductive Technology (ART) Program

Study Overview
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Brief Summary
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The purpose of this study is to investigate the efficacy and safety of cabergoline in prevention of ovarian hyperstimulation syndrome versus albumin in ART program.

Detailed Description
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Ovarian hyperstimulation syndrome (OHSS) is a iatrogenic potentially life threatening complication of assisted reproduction technologies due to gonadotropin and human chorionic gonadotropin administration. Its severe form has been reported in 1-10% of in vitro fertilization cycles. Different strategies have been proposed for the prevention of OHSS in high-risk patients, but these approaches do not offer complete protection against the development of ovarian hyperstimulation syndrome (OHSS). Among the selected preventive methods, discontinuing (coasting) gonadotropin therapy and i.v. albumin were by far the most popular choices. Several previous studies have shown that cabergoline is a safe drug, both for mother and conceptus, for the treatment of macroadenoma hyperprolactinemia. We think that this kind of therapy may be safe both for mother and conceptus (as previously shown by several studies on dopamine agonists treatment of hyperprolactinemia during pregnancy), easier, cheaper and probably, more effective than previous OHSS treatments (albumin, steroids, dopamine). There is an urgent need to test cabergoline efficacy in OHSS prevention in high risk patients with a large multicenter study. The proposal of This study approved by our institutional review boards and institution's ethical committee, and all Participants will sign a written consent before enter to study. Patients entering the intracytoplasmic sperm injection (ICSI) / IVF program in Royan institute and infertility research center in Valieasr hospital in Iran. We use a downregulation protocol with a GnRH agonist (buserelin acetate) as a long protocol for ICSI/ IVF-ET. We evaluate patients for high risk factors of severe OHSS. The inclusion criterion was the collection of >20 oocytes during oocyte retrieval. They allocate by a series of computer-generated random into two groups after the oocytes retrieval. 30 minutes after oocytes retrieval patients in A Group , receive human albumin 20% infusion and in B group receive cabergoline tablet (0/5 mg) daily until 6 days after oocytes retrieval then women in all groups will informed about the signs and symptoms of OHSS and counsel to contact with our institute if OHSS develops. Patients will monitor routinely 6days after ET by ultrasonographic examination for ovarian size and for detection of ascites. Moderate to severe OHSS patients hospitalize and evaluate routinely by haematological and biochemical tests. OHSS patients diagnose and classify according to Golan et al 1989.we compare incidence of OHSS and severity of OHSS patients in two groups. Pregnant patients follow until the 12th gestational week.

Official Title
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Compare the Efficacy of Human Albumin With Cabergoline to Prevent of Ovarian Hyper Stimulation in ART Program

Conditions
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Ovarian Hyperstimulation Syndrome

Intervention / Treatment
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* Drug: Cabergoline
* Drug: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients at risk of developing OHSS, defined by the development of 20-30 follicles larger than 12 mm in diameter and retrieval of more than 20 oocytes ovarian stimulation with long protocol Exclusion Criteria: coasting cases

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Control<br>Receive human albumin 20% infusion | Drug: Control<br>* Receive human albumin 20% infusion<br>* Other names: A;|
| Experimental: Cabergoline<br>Receive cabergoline tablet (0/5 mg) daily until 6 days after oocytes retrieval | Drug: Cabergoline<br>* Receive cabergoline tablet (0/5 mg) daily until 6 days after oocytes retrieval<br>* Other names: B;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage and severity of OHSS in two groups |  | 6 days after embryos transfer (ET) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy and safety of cabergoline and albumin |  | 6 days after embryos transfer (ET) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OHSS