PCOSPhase 3NCT01709942
Use of Degarelix in Controlled Ovarian Hyperstimulation (COH) Protocol for Women With PoliCystic Ovarian Syndrome (PCOS)
A Phase 3 study testing degarelix (long acting GnRH antagonist) and cetrorelix 0.25mg in people with PCOS and OHSS, run by Centre for Endocrinology and Reproductive Medicine, Italy at 1 site in Italy.
Trial summary
In this study the effectiveness of degarelix, a long acting GnRH antagonist administered in a unique administration of 20 mg the first day of menstrual cycle, to prevent ovarian hyperstimulation syndrome (OHSS) in PCOS women at risk to develop OHSS. Read more about this study
- Who is it for?
- Ages 20 to 38 years, women only
- Conditions the study is for
- PCOS, OHSS, INFERTILITY
- What is being tested?
- degarelix (long acting GnRH antagonist) and cetrorelix 0.25mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2012to Dec 2015
- Phase
- Phase 3
- 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 20 to 38 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- women with PCOS
- previous OHSS
- Infertility
Who cannot join
- more than 38 years old
- Body mass index pore than 30
- other systemic diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Long Acting GnRH Antagonist to Prevent Ovarian HyperStimulation Syndrome (OHSS) in PCOS Women Undergoing COH for IVF
In this study the effectiveness of degarelix, a long acting GnRH antagonist administered in a unique administration of 20 mg the first day of menstrual cycle, to prevent ovarian hyperstimulation syndrome (OHSS) in PCOS women at risk to develop OHSS.
Read the detailed description
Women with PCOS are at risk to develop OHSS when stimulated with gonadotrophins for IVF. For this reason in this study the degarelix was tested in order to minimize the risk of OHSS as well as to improve the pregnancy rate in these patients. The use of long acting GnRH antagonist promotes a deep suppression of LH and consequently the activity of theca cells, which secrete androgens (the precursors of estradiol), and consequently the levels of estradiol remains low. Comparing the long acting GnRH antagonist at the first day of cycle with a flexible GnRH antagonist protocol in a group of patients with PCOS will be useful in order to establish the best way to perform controlled hyperstimulation in IVF cycles and minimize the risk of OHSS.
- Conditions
- PCOS, OHSS, INFERTILITY
- Being tested
- degarelix (long acting GnRH antagonist), cetrorelix 0.25mg
- Keywords
- GnRH antagonist, PCOS, OHSS, COH, IVF
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
degarelix (long acting GnRH antagonist)Drug
Also called Firmagon
20 mg of degarelix the first day of menstrual cycle before starting with gonadotrophins administration
cetrorelix 0.25mgDrug
Also called cetrotide
0.25mg of cetrorelix during treatment with gonadotrophins when estradiol levels were >300pg/ml
| Study group | Role | What they receive |
|---|---|---|
| degarelix group | Experimental | group of patients treated with long acting GnRH antagonist Receives: Drug: degarelix (long acting GnRH antagonist) |
| Cetrorelix 0.25mg | Active comparator | patients treated with gonadotropin and Cetrorelix ina flexible GnRH antagonist protocol Receives: Drug: cetrorelix 0.25mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
PREGNANCY RATE
number of ongoing pregnancy obtained in the group
Measured: 6 MONTHS
ovarian hyperstimulation syndrome rate
incidence of ovarian hyperstimulation syndrome in the groups
Measured: 6 MONTHS
Secondary outcomes (1)
implantation rate
number of implanted embryos divided for the number of transferred embryos
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2012 (estimated)
- Study startNov 2012
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PCOSStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Endocrinology and Reproductive Medicine, Italy
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Fabio Scarpellini, Centre for Endocrinology and Reproductive Medicine, Italy
- Investigators
- Marco Sbracia, MD, Study chair, Centre for Endocrinology and Reproductive Medicine, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01709942
- Sponsor's protocol ID
- C05
- Status last verified
- Apr 2016
- First submitted
- 17 Oct 2012
- Last updated
- 27 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Garcia-Velasco JA, Kupesic S, Pellicer A, Bourgain C, Simon C, Mrazek M, Devroey P, Arce JC. Follicular and endocrine profiles associated with different GnRH-antagonist regimens: a randomized controlled trial. Reprod Biomed Online. 2012 Feb;24(2):153-62. doi: 10.1016/j.rbmo.2011.10.016. Epub 2011 Nov 4.
PubMed 22197127
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Long Acting GnRH Antagonist to Prevent Ovarian HyperStimulation Syndrome (OHSS) in PCOS Women Undergoing COH for IVF
- ClinicalTrials.gov ID
- NCT01709942
- Acronym / sponsor ID
- C05
- Conditions
- PCOS, OHSS, INFERTILITY
- Keywords
- GnRH antagonist, PCOS, OHSS, COH, IVF
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Centre for Endocrinology and Reproductive Medicine, ItalyResearch network
- Study start
- Nov 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 18 Oct 2012 (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.
In this study the effectiveness of degarelix, a long acting GnRH antagonist administered in a unique administration of 20 mg the first day of menstrual cycle, to prevent ovarian hyperstimulation syndrome (OHSS) in PCOS women at risk to develop OHSS.
Detailed description
Women with PCOS are at risk to develop OHSS when stimulated with gonadotrophins for IVF. For this reason in this study the degarelix was tested in order to minimize the risk of OHSS as well as to improve the pregnancy rate in these patients. The use of long acting GnRH antagonist promotes a deep suppression of LH and consequently the activity of theca cells, which secrete androgens (the precursors of estradiol), and consequently the levels of estradiol remains low. Comparing the long acting GnRH antagonist at the first day of cycle with a flexible GnRH antagonist protocol in a group of patients with PCOS will be useful in order to establish the best way to perform controlled hyperstimulation in IVF cycles and minimize the risk of OHSS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| degarelix group | Experimental | Drug: degarelix (long acting GnRH antagonist)group of patients treated with long acting GnRH antagonist |
| Cetrorelix 0.25mg | Active comparator | Drug: cetrorelix 0.25mgpatients treated with gonadotropin and Cetrorelix ina flexible GnRH antagonist protocol |
Who may qualify
- Ages
- 20 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- women with PCOS
- previous OHSS
- Infertility
Key exclusion criteria (3 listed)
- more than 38 years old
- Body mass index pore than 30
- other systemic diseases
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 |
|---|---|---|
| degarelix (long acting GnRH antagonist)Also: Firmagon20 mg of degarelix the first day of menstrual cycle before starting with gonadotrophins administration | Drug | degarelix group |
| cetrorelix 0.25mgAlso: cetrotide0.25mg of cetrorelix during treatment with gonadotrophins when estradiol levels were >300pg/ml | Drug | Cetrorelix 0.25mg |
Primary outcome
PREGNANCY RATE
Time frame: 6 MONTHS
number of ongoing pregnancy obtained in the group
ovarian hyperstimulation syndrome rate
Time frame: 6 MONTHS
incidence of ovarian hyperstimulation syndrome in the groups
1 secondary outcome
implantation rate
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2016.
- Results publication: PubMed 22197127Garcia-Velasco JA, Kupesic S, Pellicer A, Bourgain C, Simon C, Mrazek M, Devroey P, Arce JC. Follicular and endocrine profiles associated with different GnRH-antagonist regimens: a randomized controlled trial. Reprod Biomed Online. 2012 Feb;24(2):153-62. doi: 10.1016/j.rbmo.2011.10.016. Epub 2011 Nov 4.
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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.
Marco Sbracia, MD study chair
Centre for Endocrinology and Reproductive Medicine, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing degarelix (long acting GnRH antagonist) and cetrorelix 0.25mg in people with PCOS and OHSS, run by Centre for Endocrinology and Reproductive Medicine, Italy at 1 site in Italy.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 27 Apr 2016. 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 Italy. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PREGNANCY RATE (time frame: 6 MONTHS). The study lists 2 primary outcomes in all. 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 NCT01709942, which also lists 1 linked publication.
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 27 Apr 2016.