Luteal Antagonist Versus Conventional Treatment in Women With Severe Early Ovarian Hyperstimulation Syndrome (OHSS)
Study Details
Study Description
Brief Summary
The study aims to compare the novel method of GnRH antagonist administration in the luteal phase versus conventional treatment in IVF patients who develop severe early ovarian hyperstimulation syndrome and have all their embryos cryopreserved.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
GnRH antagonist administration in the luteal phase has been proposed as a strategy for the treatment of established severe early OHSS, causing rapid regression of the syndrome on an outpatient basis. The approach has been described as tertiary OHSS prevention, thereby complementing the primary prevention (GnRH antagonist protocol) and secondary prevention (GnRH agonist trigger) that constitute the OHSS-free clinic concept. No randomized controlled trials (RCT) exist to date comparing luteal GnRH antagonist administration versus conventional treatment.
The aim of the present study is to compare the novel method of GnRH antagonist administration in the luteal phase versus conventional treatment with primary outcome time to severe OHSS regression, in IVF patients who develop severe early OHSS and have all their embryos cryopreserved.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Antagonist 0.25 mg GnRH antagonist cetrorelix will be administered once daily for 4 days, starting on the day of severe early OHSS diagnosis |
Drug: cetrorelix (cetrotide)
0.25 mg GnRH antagonist cetrorelix will be administered once daily for 4 days, starting on the day of severe early OHSS diagnosis
Other Names:
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| Placebo Comparator: Conventional Women with severe early OHSS will be treated with conventional treatment, such as intravenous albumin administration, paracentesis of ascitic fluid, either on an outpatient or inpatient basis. |
Drug: Placebo
intravenous albumin administration, paracentesis of ascitic fluid, correction of electrolyte imbalance and intravascular volume
Other Names:
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Outcome Measures
Primary Outcome Measures
- Time to severe OHSS regression [2- 21 days after severe OHSS diagnosis]
Secondary Outcome Measures
- Need for patient hospitalization [2- 21 days after severe OHSS diagnosis]
- Hematocrit levels [8 days after severe early OHSS diagnosis]
- White blood cells [8 days after severe early OHSS diagnosis]
- Diameter of ovaries [8 days after severe early OHSS diagnosis]
- Quantity of ascites [8 days after severe early OHSS diagnosis]
- Estradiol levels [8 days after severe early OHSS diagnosis]
- Progesterone levels [8 days after severe early OHSS diagnosis]
- Serum levels of vascular endothelial growth factor (VEGF) [8 days after severe early OHSS diagnosis]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Women with established severe early OHSS.
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Criteria for the diagnosis of severe OHSS require:
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the presence of moderate (or higher) ascites and at least two of the following:
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enlarged ovaries (>100 mm maximal diameter),
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haematocrit (Ht) >45%,
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white blood cell count (WBC) >15,000/mm3.
Exclusion Criteria:
- Women not fulfilling the above criteria
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Eugonia Unit of Assisted Reproduction | Athens | Greece | 11528 |
Sponsors and Collaborators
- Eugonia
Investigators
- Principal Investigator: George T Lainas, MD, Barts and The London NHS Trust (ART Unit)
Study Documents (Full-Text)
None provided.More Information
Publications
- Lainas GT, Kolibianakis EM, Sfontouris IA, Zorzovilis IZ, Petsas GK, Lainas TG, Tarlatzis BC. Pregnancy and neonatal outcomes following luteal GnRH antagonist administration in patients with severe early OHSS. Hum Reprod. 2013 Jul;28(7):1929-42. doi: 10.1093/humrep/det114. Epub 2013 Apr 26.
- Lainas GT, Kolibianakis EM, Sfontouris IA, Zorzovilis IZ, Petsas GK, Lainas TG, Tarlatzis BC. Serum vascular endothelial growth factor levels following luteal gonadotrophin-releasing hormone antagonist administration in women with severe early ovarian hyperstimulation syndrome. BJOG. 2014 Jun;121(7):848-55. doi: 10.1111/1471-0528.12572. Epub 2014 Feb 12.
- Lainas GT, Kolibianakis EM, Sfontouris IA, Zorzovilis IZ, Petsas GK, Tarlatzi TB, Tarlatzis BC, Lainas TG. Outpatient management of severe early OHSS by administration of GnRH antagonist in the luteal phase: an observational cohort study. Reprod Biol Endocrinol. 2012 Aug 31;10:69. doi: 10.1186/1477-7827-10-69.
- Lainas TG, Sfontouris IA, Zorzovilis IZ, Petsas GK, Lainas GT, Alexopoulou E, Kolibianakis EM. Live births after management of severe OHSS by GnRH antagonist administration in the luteal phase. Reprod Biomed Online. 2009 Dec;19(6):789-95.
- Lainas TG, Sfontouris IA, Zorzovilis IZ, Petsas GK, Lainas GT, Iliadis GS, Kolibianakis EM. Management of severe OHSS using GnRH antagonist and blastocyst cryopreservation in PCOS patients treated with long protocol. Reprod Biomed Online. 2009 Jan;18(1):15-20.
- Lainas TG, Sfontouris IA, Zorzovilis IZ, Petsas GK, Lainas GT, Kolibianakis EM. Management of severe early ovarian hyperstimulation syndrome by re-initiation of GnRH antagonist. Reprod Biomed Online. 2007 Oct;15(4):408-12.
- luteal antag OHSS RCT