Polycystic Ovarian SyndromeNCT02084940
Long Acting GnRH Antagonist in PCOS Women Undergoing IVF
An observational study of Polycystic Ovarian Syndrome and Ovarian Hyperstimulation Syndrome, run by Bioroma at 1 site in Italy.
Trial summary
PCOS is a common endocrinopathy affecting 5-10% of women in their reproductive age characterized by hyperandrogenism, chronic anovulation and polycystic ovaries. This syndrome is a serious problem in IVF since there is a high risk of developing ovarian hyperstimulation syndrome (OHSS) during ovarian stimulation with… Read more about this study
- Who is it for?
- Ages 23 to 37 years, women only
- Conditions the study is for
- Polycystic Ovarian Syndrome, Ovarian Hyperstimulation Syndrome, Invitro Fertilization
- What is being tested?
- GnRH antagonist depot Degarelix
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2014to Feb 2015
- Phase
- Observational
- 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 23 to 37 years
- Women only
- No healthy volunteers
- Adult
Study population: Women with PCOS with a previous IVF attempt cancelled due to the risk of OHSS
Who may be able to join
- regular menstrual cycle (26-39 days)
- primary infertility
- BMI < 30
Who cannot join
- women with diabetes and other metabolic disease
- women with heart disease
- women with inflammatory or autoimmune disease
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Bioroma
Rome, Italy, 00197
Mauro Schimberni, MD, +39063334266, bioroma@bioroma.net
Mauro Schimberni, MD
About this study
Official title: The Use of a Long Acting GnRH Antagonist (Degarelix) in Controlled Ovarian Hyperstimulation in PCOS Women at a Risk to Developing OHSS Undergoing IVF : a Pilot Study
PCOS is a common endocrinopathy affecting 5-10% of women in their reproductive age characterized by hyperandrogenism, chronic anovulation and polycystic ovaries. This syndrome is a serious problem in IVF since there is a high risk of developing ovarian hyperstimulation syndrome (OHSS) during ovarian stimulation with gonadotropins. The introduction of GnRH antagonist in IVF has reduced the incidence of severe OHSS, still maintaining a good ovarian response and pregnancy rate. Recently, a long acting GnRH antagonist, Degarelix, was introduced for prostatic cancer treatment. Furthermore a recent paper reported its use also for the induction of multiple follicular growth in a program of oocyte donation. The aim of this study is to evaluate the feasibility of GnRH antagonist depot use in a protocol of controlled ovarian hyperstimulation in PCOS women at risk of developing OHSS in IVF cycles.
- Being tested
- GnRH antagonist depot Degarelix
- Keywords
- PCOS, OHSS, GnRH antagonist, IVF, COH
- Medical subject headings
- Polycystic Ovary Syndrome, Ovarian Hyperstimulation Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GnRH antagonist depot DegarelixDrug
Women receive 20 mg of Degarelix on the first day of menstrual cycle followed by a fixed dose of 225 IU of recombinant FSH on the second day until the day of ovulation triggering
| Study group | Role | What they receive |
|---|---|---|
| GnRH antagonist depot, Degarelix | Women receive 20 mg of Degarelix on the first day of menstrual cycle followed by a fixed dose of 225 IU of recombinant FSH on the second day until the day of ovulation triggering Receives: Drug: GnRH antagonist depot Degarelix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy rate
Measured: Time Frame: until 12th gestational week
Incidence of OHSS
Measured: Time frame: until 7th gestational week
Secondary outcomes (5)
Number of collected oocytes
Measured: Time Frame: until 12th gestational week
Estradiol level at HCG day
Measured: time frame: until 12th gestational week
Total dose of FSH administered
Measured: Time frame: until 12th gestational week
Total days of stimulation
Measured: Time frame: until 12th gestational week
implantation rate
Measured: time frame: until 12th gestational week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionDec 2014 (estimated)
- Study completionFeb 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovarian 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bioroma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02084940
- Sponsor's protocol ID
- BRM002
- Status last verified
- Mar 2014
- First submitted
- 10 Mar 2014
- Last updated
- 12 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of a Long Acting GnRH Antagonist (Degarelix) in Controlled Ovarian Hyperstimulation in PCOS Women at a Risk to Developing OHSS Undergoing IVF : a Pilot Study
- ClinicalTrials.gov ID
- NCT02084940
- Acronym / sponsor ID
- BRM002
- Keywords
- PCOS, OHSS, GnRH antagonist, IVF, COH
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- BioromaUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Feb 2015 (estimated)
- First posted
- 12 Mar 2014 (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.
PCOS is a common endocrinopathy affecting 5-10% of women in their reproductive age characterized by hyperandrogenism, chronic anovulation and polycystic ovaries. This syndrome is a serious problem in IVF since there is a high risk of developing ovarian hyperstimulation syndrome (OHSS) during ovarian stimulation with gonadotropins. The introduction of GnRH antagonist in IVF has reduced the incidence of severe OHSS, still maintaining a good ovarian response and pregnancy rate. Recently, a long acting GnRH antagonist, Degarelix, was introduced for prostatic cancer treatment. Furthermore a recent paper reported its use also for the induction of multiple follicular growth in a program of oocyte donation. The aim of this study is to evaluate the feasibility of GnRH antagonist depot use in a protocol of controlled ovarian hyperstimulation in PCOS women at risk of developing OHSS in IVF cycles.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GnRH antagonist depot, Degarelix | – | Drug: GnRH antagonist depot DegarelixWomen receive 20 mg of Degarelix on the first day of menstrual cycle followed by a fixed dose of 225 IU of recombinant FSH on the second day until the day of ovulation triggering |
Who may qualify
- Ages
- 23 to 37 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women with PCOS with a previous IVF attempt cancelled due to the risk of OHSS
Key inclusion criteria (3 listed)
- regular menstrual cycle (26-39 days)
- primary infertility
- BMI < 30
Key exclusion criteria (3 listed)
- women with diabetes and other metabolic disease
- women with heart disease
- women with inflammatory or autoimmune disease
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 |
|---|---|---|
| GnRH antagonist depot DegarelixWomen receive 20 mg of Degarelix on the first day of menstrual cycle followed by a fixed dose of 225 IU of recombinant FSH on the second day until the day of ovulation triggering | Drug | GnRH antagonist depot, Degarelix |
Primary outcome
Pregnancy rate
Time frame: Time Frame: until 12th gestational week
Incidence of OHSS
Time frame: Time frame: until 7th gestational week
5 secondary outcomes
Number of collected oocytes
Time frame: Time Frame: until 12th gestational week
Estradiol level at HCG day
Time frame: time frame: until 12th gestational week
Total dose of FSH administered
Time frame: Time frame: until 12th gestational week
Total days of stimulation
Time frame: Time frame: until 12th gestational week
implantation rate
Time frame: time frame: until 12th gestational week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2014.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Polycystic Ovarian Syndrome and Ovarian Hyperstimulation Syndrome, run by Bioroma 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: status not confirmed, as of the sponsor's last update on 12 Mar 2014. 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.
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 Mauro Schimberni, MD (+39063334266, bioroma@bioroma.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pregnancy rate (time frame: Time Frame: until 12th gestational week). 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?
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 12 Mar 2014.