Clinical trial NCT02392520: Luteal Antagonist Versus Conventional Treatment in Women With Severe Early Ovarian Hyperstimulation Syndrome (OHSS)
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ovarian Hyperstimulation Syndrome
Keywords: severe OHSS
antagonist administration
conventional treatment
Lead sponsor: Eugonia
Sponsor class: OTHER
First posted: 2015-03-19
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Time to severe OHSS regression
timeFrame: 2- 21 days after severe OHSS diagnosis
Secondary outcomes:
measure: Need for patient hospitalization
timeFrame: 2- 21 days after severe OHSS diagnosis
measure: Hematocrit levels
timeFrame: 8 days after severe early OHSS diagnosis
measure: White blood cells
timeFrame: 8 days after severe early OHSS diagnosis
measure: Diameter of ovaries
timeFrame: 8 days after severe early OHSS diagnosis
measure: Quantity of ascites
timeFrame: 8 days after severe early OHSS diagnosis
measure: Estradiol levels
timeFrame: 8 days after severe early OHSS diagnosis
measure: Progesterone levels
timeFrame: 8 days after severe early OHSS diagnosis
measure: Serum levels of vascular endothelial growth factor (VEGF)
timeFrame: 8 days after severe early OHSS diagnosis
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Eugonia Unit of Assisted Reproduction
Study officials:
affiliation: Barts and The London NHS Trust (ART Unit)
name: George T Lainas, MD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1016/s1472-6483(10)60366-5.
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. doi: 10.1016/s1472-6483(10)60419-1.
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. doi: 10.1016/j.rbmo.2009.09.021.
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.
citation: 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.
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.