Compare the Efficacy of Human Albumin With Cabergoline to Prevent Ovarian Hyper Stimulation in Assisted Reproductive Technology (ART) Program
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ClinicalTrials.gov Identifier: NCT01009567 |
Recruitment Status :
Completed
First Posted : November 6, 2009
Last Update Posted : May 6, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Ovarian Hyperstimulation Syndrome | Drug: Cabergoline Drug: Control | Phase 1 Phase 2 |
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 10 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Compare the Efficacy of Human Albumin With Cabergoline to Prevent of Ovarian Hyper Stimulation in ART Program |
Study Start Date : | June 2009 |
Actual Primary Completion Date : | June 2013 |
Actual Study Completion Date : | July 2013 |

Arm | Intervention/treatment |
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Sham Comparator: Control
Receive human albumin 20% infusion
|
Drug: Control
Receive human albumin 20% infusion
Other Name: A |
Experimental: Cabergoline
Receive cabergoline tablet (0/5 mg) daily until 6 days after oocytes retrieval
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Drug: Cabergoline
Receive cabergoline tablet (0/5 mg) daily until 6 days after oocytes retrieval
Other Name: B |
- Percentage and severity of OHSS in two groups [ Time Frame: 6 days after embryos transfer (ET) ]
- Efficacy and safety of cabergoline and albumin [ Time Frame: 6 days after embryos transfer (ET) ]

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Ages Eligible for Study: | 25 Years to 45 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01009567
Iran, Islamic Republic of | |
Endocrinology and Female Infertility Department, Reproductive Medicine Research Center, Royan institute, ACECR | |
Tehran, Iran, Islamic Republic of, 14114 |
Study Director: | Eniseh Tehraninejad, MD | Royan Institute | |
Study Director: | Ashraf Moini, MD | Board scientific | |
Principal Investigator: | Marzieh Shiva, MD | scientist |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Royan Institute |
ClinicalTrials.gov Identifier: | NCT01009567 |
Other Study ID Numbers: |
Royan-Emb-004 |
First Posted: | November 6, 2009 Key Record Dates |
Last Update Posted: | May 6, 2015 |
Last Verified: | November 2009 |
OHSS |
Ovarian Hyperstimulation Syndrome Ovarian Diseases Adnexal Diseases Gonadal Disorders Endocrine System Diseases Cabergoline Antiparkinson Agents |
Anti-Dyskinesia Agents Dopamine Agonists Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |