Luteal Antagonist Versus Conventional Treatment in Women With Severe Early Ovarian Hyperstimulation Syndrome (OHSS)

Ovarian Hyperstimulation Syndrome Clinical Trial

Official title:

GnRH Antagonist in the Luteal Phase Compared to Conventional Treatment in Women With Severe Early Ovarian Hyperstimulation Syndrome (OHSS) in Whom All Embryos Are Cryopreserved

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02392520
• Other study ID #: luteal antag OHSS RCT
• Status: Not yet recruiting
• Phase: N/A
• First received: March 13, 2015
• Last updated: March 18, 2015
• Start date: May 2015
• Est. completion date: December 2016

Study information

• Verified date: March 2015
• Source: Eugonia
• Contact: George T Lainas, PhD
• Phone: 00447969111871
• Email: ggslns[@]gmail.com
• Is FDA regulated: No
• Health authority: Greece: National Organization of Medicines
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

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:

• enlarged ovaries (>100 mm maximal diameter),

• haematocrit (Ht) >45%,

• white blood cell count (WBC) >15,000/mm3.

Exclusion Criteria:

• Women not fulfilling the above criteria

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ovarian Hyperstimulation Syndrome
• Syndrome

Intervention

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
• Placebo
intravenous albumin administration, paracentesis of ascitic fluid, correction of electrolyte imbalance and intravascular volume

Locations

Country	Name	City	State
Greece	Eugonia Unit of Assisted Reproduction	Athens

Sponsors (1)

Lead Sponsor	Collaborator
Eugonia

Country where clinical trial is conducted

Greece, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to severe OHSS regression		2- 21 days after severe OHSS diagnosis	No
Secondary	Need for patient hospitalization		2- 21 days after severe OHSS diagnosis	Yes
Secondary	Hematocrit levels		8 days after severe early OHSS diagnosis	No
Secondary	White blood cells		8 days after severe early OHSS diagnosis	No
Secondary	Diameter of ovaries		8 days after severe early OHSS diagnosis	No
Secondary	Quantity of ascites		8 days after severe early OHSS diagnosis	No
Secondary	Estradiol levels		8 days after severe early OHSS diagnosis	No
Secondary	Progesterone levels		8 days after severe early OHSS diagnosis	No
Secondary	Serum levels of vascular endothelial growth factor (VEGF)		8 days after severe early OHSS diagnosis	No