NCT02392520

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 13, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 19, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

March 19, 2015

Status Verified

March 1, 2015

Enrollment Period

10 months

First QC Date

March 13, 2015

Last Update Submit

March 18, 2015

Conditions

Ovarian Hyperstimulation Syndrome

Keywords

severe OHSSantagonist administrationconventional treatment

Outcome Measures

Primary Outcomes (1)

  • Time to severe OHSS regression

    2- 21 days after severe OHSS diagnosis

Secondary Outcomes (8)

  • 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

  • +3 more secondary outcomes

Study Arms (2)

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

Drug: cetrorelix (cetrotide)

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.

Drug: Placebo

Interventions

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

Also known as: GnRH antagonist
Antagonist
PlaceboDRUG

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

Also known as: conventional treatment
Conventional

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Women not fulfilling the above criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eugonia Unit of Assisted Reproduction

Athens, 11528, Greece

Location

Related Publications (6)

  • 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.

    PMID: 17908403BACKGROUND

  • 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.

    PMID: 19146764BACKGROUND

  • 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.

    PMID: 20031018BACKGROUND

  • 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.

    PMID: 22938051BACKGROUND

  • 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.

    PMID: 23624582BACKGROUND

  • 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.

    PMID: 24621101BACKGROUND

MeSH Terms

Conditions

Ovarian Hyperstimulation Syndrome

Interventions

cetrorelixLHRH, Ac-Nal(1)-Cpa(2)-Trp(3)-Arg(6)-Ala(10)-

Condition Hierarchy (Ancestors)

Ovarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Study Officials

  • George T Lainas, MD

    Barts and The London NHS Trust (ART Unit)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

George T Lainas, PhD

CONTACT

00447969111871ggslns@gmail.com

Trifon G Lainas, PhD

CONTACT

00302107236333tlainas@otenet.gr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2015

First Posted

March 19, 2015

Study Start

May 1, 2015

Primary Completion

March 1, 2016

Study Completion

December 1, 2016

Last Updated

March 19, 2015

Record last verified: 2015-03

Locations

GR(1)