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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Antagonist | Experimental | 0.25 mg GnRH antagonist cetrorelix will be administered once daily for 4 days, starting on the day of severe early OHSS diagnosis |
|
| Conventional | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cetrorelix (cetrotide) | Drug | 0.25 mg GnRH antagonist cetrorelix will be administered once daily for 4 days, starting on the day of severe early OHSS diagnosis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to severe OHSS regression | 2- 21 days after severe OHSS diagnosis |
| Measure | Description | Time Frame |
|---|---|---|
| Need for patient hospitalization | 2- 21 days after severe OHSS diagnosis | |
| Hematocrit levels | 8 days after severe early OHSS diagnosis | |
| White blood cells |
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Inclusion Criteria:
Women with established severe early OHSS.
Criteria for the diagnosis of severe OHSS require:
the presence of moderate (or higher) ascites and at least two of the following:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| George T Lainas, PhD | Contact | 00447969111871 | ggslns@gmail.com | |
| Trifon G Lainas, PhD | Contact | 00302107236333 | tlainas@otenet.gr |
| Name | Affiliation | Role |
|---|---|---|
| George T Lainas, MD | Barts and The London NHS Trust (ART Unit) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eugonia Unit of Assisted Reproduction | Athens | 11528 | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17908403 | Background | 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. doi: 10.1016/s1472-6483(10)60366-5. | |
| 19146764 | Background | 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. doi: 10.1016/s1472-6483(10)60419-1. |
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| ID | Term |
|---|---|
| D016471 | Ovarian Hyperstimulation Syndrome |
| ID | Term |
|---|---|
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| C062876 | cetrorelix |
| C092464 | LHRH, Ac-Nal(1)-Cpa(2)-Trp(3)-Arg(6)-Ala(10)- |
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|
| Placebo | Drug | intravenous albumin administration, paracentesis of ascitic fluid, correction of electrolyte imbalance and intravascular volume |
|
|
| 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 |
| 20031018 | Background | 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. doi: 10.1016/j.rbmo.2009.09.021. |
| 22938051 | Background | 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. |
| 23624582 | Background | 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. |
| 24621101 | Background | 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. |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |