Ovarian Hyperstimulation SyndromeNCT02392520
Luteal Antagonist Versus Conventional Treatment in Women With Severe Early Ovarian Hyperstimulation Syndrome (OHSS)
A study testing cetrorelix (cetrotide) in people with Ovarian Hyperstimulation Syndrome, run by Eugonia at 1 site in Greece.
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. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ovarian Hyperstimulation Syndrome
- What is being tested?
- cetrorelix (cetrotide)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteGreece
- Study dates
- May 2015to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Women not fulfilling the above criteria
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Ovarian Hyperstimulation Syndrome
- Being tested
- cetrorelix (cetrotide), Placebo
- Keywords
- severe OHSS, antagonist administration, conventional treatment
- Medical subject headings
- Ovarian Hyperstimulation Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cetrorelix (cetrotide)Drug
Also called GnRH antagonist
0.25 mg GnRH antagonist cetrorelix will be administered once daily for 4 days, starting on the day of severe early OHSS diagnosis
PlaceboDrug
Also called conventional treatment
intravenous albumin administration, paracentesis of ascitic fluid, correction of electrolyte imbalance and intravascular volume
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to severe OHSS regression
Measured: 2- 21 days after severe OHSS diagnosis
Secondary outcomes (8)
Need for patient hospitalization
Measured: 2- 21 days after severe OHSS diagnosis
Hematocrit levels
Measured: 8 days after severe early OHSS diagnosis
White blood cells
Measured: 8 days after severe early OHSS diagnosis
Diameter of ovaries
Measured: 8 days after severe early OHSS diagnosis
Quantity of ascites
Measured: 8 days after severe early OHSS diagnosis
Estradiol levels
Measured: 8 days after severe early OHSS diagnosis
Progesterone levels
Measured: 8 days after severe early OHSS diagnosis
Serum levels of vascular endothelial growth factor (VEGF)
Measured: 8 days after severe early OHSS diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2015 (estimated)
- Study startMay 2015
- Primary completionMar 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Ovarian Hyperstimulation SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eugonia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- George T Lainas, MD, Principal investigator, Barts and The London NHS Trust (ART Unit)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02392520
- Sponsor's protocol ID
- luteal antag OHSS RCT
- Status last verified
- Mar 2015
- First submitted
- 13 Mar 2015
- Last updated
- 19 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 17908403Lainas 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.
PubMed 19146764Lainas 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.
PubMed 20031018Lainas 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.
PubMed 22938051Lainas 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.
PubMed 23624582Lainas 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.
PubMed 24621101
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02392520
- Acronym / sponsor ID
- luteal antag OHSS RCT
- Conditions
- Ovarian Hyperstimulation Syndrome
- Keywords
- severe OHSS, antagonist administration, conventional treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- EugoniaUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 19 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antagonist | Experimental | 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 |
| Conventional | Placebo comparator | Drug: PlaceboWomen 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. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Women with established severe early OHSS.
- Criteria for the diagnosis of severe OHSS require:
Key exclusion criteria (1 listed)
- Women not fulfilling the above criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cetrorelix (cetrotide)Also: GnRH antagonist0.25 mg GnRH antagonist cetrorelix will be administered once daily for 4 days, starting on the day of severe early OHSS diagnosis | Drug | Antagonist |
| PlaceboAlso: conventional treatmentintravenous albumin administration, paracentesis of ascitic fluid, correction of electrolyte imbalance and intravascular volume | Drug | Conventional |
Primary outcome
Time to severe OHSS regression
Time frame: 2- 21 days after severe OHSS diagnosis
8 secondary outcomes
Need for patient hospitalization
Time frame: 2- 21 days after severe OHSS diagnosis
Hematocrit levels
Time frame: 8 days after severe early OHSS diagnosis
White blood cells
Time frame: 8 days after severe early OHSS diagnosis
Diameter of ovaries
Time frame: 8 days after severe early OHSS diagnosis
Quantity of ascites
Time frame: 8 days after severe early OHSS diagnosis
Estradiol levels
Time frame: 8 days after severe early OHSS diagnosis
Progesterone levels
Time frame: 8 days after severe early OHSS diagnosis
Serum levels of vascular endothelial growth factor (VEGF)
Time frame: 8 days after severe early OHSS diagnosis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2015.
- Background: PubMed 17908403Lainas 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.
- Background: PubMed 19146764Lainas 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.
- Background: PubMed 20031018Lainas 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.
- Background: PubMed 22938051Lainas 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.
- Background: PubMed 23624582Lainas 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.
- Background: PubMed 24621101Lainas 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
George T Lainas, MD principal investigator
Barts and The London NHS Trust (ART Unit)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cetrorelix (cetrotide) in people with Ovarian Hyperstimulation Syndrome, run by Eugonia at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact George T Lainas, PhD (00447969111871, ggslns@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to severe OHSS regression (time frame: 2- 21 days after severe OHSS diagnosis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02392520, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2015.