Female InfertilityPhase 4NCT02070198
Long Acting FSH Plus Antagonist Versus Daily FSH Plus Antagonist Versus Short Agonist Protocol in Poor Responders Undergoing IVF
A Phase 4 study testing Long acting FSH and GnRH antagonist, Daily FSH and GnRH antagonist and Triptorelin and recombinant FSH in people with Female Infertility and Poor Responder, run by Bioroma at 1 site in Italy.
Trial summary
Despite the progression in assisted reproductive technology (ART), poor ovarian response to controlled ovarian stimulation remains a challenge for clinicians and a source of distress for patients. Multiple strategies have been tried to overcome these obstacles. Read more about this study
- Who is it for?
- Ages 25 to 44 years, women only
- Conditions the study is for
- Female Infertility, Poor Responder
- What is being tested?
- Long acting FSH and GnRH antagonist, Daily FSH and GnRH antagonist and Triptorelin and recombinant FSH
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteItaly
- Study dates
- Dec 2013to Dec 2014
- Phase
- Phase 4
- 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 25 to 44 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- women with at least two of the following criteria: I) age > 40 years old; II) basal follicular stimulation hormone (FSH) > 12 mIU/ml; III) three or fewer oocytes retrieved in the previous IVF cycle; IV) low estradiol levels on the day of human chorionic gonadotropin (hCG) administration (< 1500 pmol/ml).
Who cannot join
- body mass index > 30
- biochemical and ultrasound evidence of polycystic ovary syndrome
- stage III-IV endometriosis
- inflammatory or autoimmune disorders
- metabolic disease
- infertility medications (gonadotropins, clomiphene citrate) within the past two months
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Bioroma
Rome, Italy, 00197
Mauro Schimberni, +39063334266, bioroma@bioroma.net
Mauro Schimberni
About this study
Official title: Long Acting FSH Plus GnRH Antagonist Versus Daily FSH Plus GnRH Antagonist Versus Short Agonist Regimens in Poor Responder Patients Undergoing IVF: a Randomized Study.
Despite the progression in assisted reproductive technology (ART), poor ovarian response to controlled ovarian stimulation remains a challenge for clinicians and a source of distress for patients. Multiple strategies have been tried to overcome these obstacles. The increase of the gonadotropin administration have been associated with a very low pregnancy rate. The introduction of GnRH agonist protocol, which takes advantage of the initial rise in endogenous gonadotropins that follows the agonist administration in the early follicular phase and subsequently prevents a premature LH surge, with fewer cycle cancellations, have improved cycle parameters and increased pregnancy rate. Recently, GnRH antagonists were introduced in ART treatment. They are effective in preventing a premature LH surge and allow for a more natural recruitment of follicles in the follicular phase in a non suppressed ovary. However, the randomized studies comparing the efficacy of these two regimens reported conflicting and nonsignificant results. Moreover, more recently adjuvant therapies for COH such as growth hormone therapy or pyridostigmine, oral L-arginine, and transdermal testosterone failed to improve IVF outcomes. Recently, the new treatment option with corifollitropin alfa, able to keep the circulating FSH level above the threshold necessary to support multi-follicular growth for an entire week, in a GnRH antagonist protocol seems to have a potential beneficial effect in poor responders.
The aim of this study is to compare long-acting FSH/GnRH antagonist with daily FSH/GnRH antagonist with short GnRH agonist protocol on IVF outcome in poor responder patients .
- Conditions
- Female Infertility, Poor Responder
- Being tested
- Long acting FSH and GnRH antagonist, Daily FSH and GnRH antagonist, Triptorelin and recombinant FSH
- Keywords
- Poor responders, IVF, GnRH agonist, GnRH antagonist, recombinant FSH
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Long acting FSH and GnRH antagonistDrug
Woman in long acting FSH and GnRH antagonist arm receive an initial dose of 150 mcg Corifollitropin alfa on second day of the menstrual cycle followed by a fixed daily dose of 0.25 mg of GnRH antagonist on day 7 of the cycle onwards. On the ninth day of the cycle, a daily fixed dose of 300 IU of recombinant FSH will be administered until the day of ovulation triggering.
Daily FSH and GnRH antagonistDrug
Woman in daily FSH and GnRH antagonist arm receive a fixed dose of 300 IU of recombinantFSH starting 3 day of the menstrual cycle followed by a fixed daily dose of 0.25 mg of GnRH antagonist on day 7 of the cycle onwards until the day of ovulation triggering.
Triptorelin and recombinant FSHDrug
Women in Triptorelin and recombinant FSH arm receive a fixed dose of 0.05 mg of Triprorelin from the 1 day of the menstrual cycle followed by a fixed dose of 300 IU of recombinant FSH starting 3 day untill the day of HCG administration.
| Study group | Role | What they receive |
|---|---|---|
| Long acting FSH and GnrH antagonist | Experimental | Woman in long acting FSH and GnRH antagonist arm receive an initial dose of 150 mcg Corifollitropin alfa on second day of the menstrual cycle followed by a fixed daily dose of 0.25 mg of GnRH antagonist on day 7 of the cycle onwards. On the ninth day of the cycle, a daily fixed dose of 300 IU of recombinant FSH will be administered until the day of ovulation triggering. Receives: Drug: Long acting FSH and GnRH antagonist |
| daily FSH and GnRH antagonist | Experimental | Woman in daily FSH and GnRH antagonist arm receive a fixed dose of 300 IU of recombinantFSH starting 3 day of the menstrual cycle followed by a fixed daily dose of 0.25 mg of GnRH antagonist on day 7 of the cycle onwards until the day of ovulation triggering. Receives: Drug: Daily FSH and GnRH antagonist |
| Triptorelin and recombinant FSH | Experimental | Women in triptorelin and recombinant FSH arm receive a fixed dose of 0.05 mg of triprorelin from the 1 day of the menstrual cycle followed by a fixed dose of 300 IU of recombinant FSH starting 3 day until the day of HCG administration. Receives: Drug: Triptorelin and recombinant FSH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy rate
Measured: Time Frame: until 12th gestational week
Secondary outcomes (1)
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 posted25 Feb 2014 (estimated)
- Study startDec 2013
- Primary completionNov 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female InfertilityStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bioroma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mauro Schimberni, MD, Principal investigator, Bioroma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02070198
- Sponsor's protocol ID
- BRM001
- Status last verified
- Feb 2014
- First submitted
- 20 Feb 2014
- Last updated
- 25 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Acting FSH Plus GnRH Antagonist Versus Daily FSH Plus GnRH Antagonist Versus Short Agonist Regimens in Poor Responder Patients Undergoing IVF: a Randomized Study.
- ClinicalTrials.gov ID
- NCT02070198
- Acronym / sponsor ID
- BRM001
- Conditions
- Female Infertility, Poor Responder
- Keywords
- Poor responders, IVF, GnRH agonist, GnRH antagonist, recombinant FSH
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- BioromaUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Nov 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 25 Feb 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.
Despite the progression in assisted reproductive technology (ART), poor ovarian response to controlled ovarian stimulation remains a challenge for clinicians and a source of distress for patients. Multiple strategies have been tried to overcome these obstacles. The increase of the gonadotropin administration have been associated with a very low pregnancy rate. The introduction of GnRH agonist protocol, which takes advantage of the initial rise in endogenous gonadotropins that follows the agonist administration in the early follicular phase and subsequently prevents a premature LH surge, with fewer cycle cancellations, have improved cycle parameters and increased pregnancy rate. Recently, GnRH antagonists were introduced in ART treatment. They are effective in preventing a premature LH surge and allow for a more natural recruitment of follicles in the follicular phase in a non suppressed ovary. However, the randomized studies comparing the efficacy of these two regimens reported conflicting and nonsignificant results. Moreover, more recently adjuvant therapies for COH such as growth hormone therapy or pyridostigmine, oral L-arginine, and transdermal testosterone failed to improve IVF outcomes. Recently, the new treatment option with corifollitropin alfa, able to keep the circulating FSH level above the threshold necessary to support multi-follicular growth for an entire week, in a GnRH antagonist protocol seems to have a potential beneficial effect in poor responders.
The aim of this study is to compare long-acting FSH/GnRH antagonist with daily FSH/GnRH antagonist with short GnRH agonist protocol on IVF outcome in poor responder patients .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Long acting FSH and GnrH antagonist | Experimental | Drug: Long acting FSH and GnRH antagonistWoman in long acting FSH and GnRH antagonist arm receive an initial dose of 150 mcg Corifollitropin alfa on second day of the menstrual cycle followed by a fixed daily dose of 0.25 mg of GnRH antagonist on day 7 of the cycle onwards. On the ninth day of the cycle, a daily fixed dose of 300 IU of recombinant FSH will be administered until the day of ovulation triggering. |
| daily FSH and GnRH antagonist | Experimental | Drug: Daily FSH and GnRH antagonistWoman in daily FSH and GnRH antagonist arm receive a fixed dose of 300 IU of recombinantFSH starting 3 day of the menstrual cycle followed by a fixed daily dose of 0.25 mg of GnRH antagonist on day 7 of the cycle onwards until the day of ovulation triggering. |
| Triptorelin and recombinant FSH | Experimental | Drug: Triptorelin and recombinant FSHWomen in triptorelin and recombinant FSH arm receive a fixed dose of 0.05 mg of triprorelin from the 1 day of the menstrual cycle followed by a fixed dose of 300 IU of recombinant FSH starting 3 day until the day of HCG administration. |
Who may qualify
- Ages
- 25 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- women with at least two of the following criteria: I) age > 40 years old; II) basal follicular stimulation hormone (FSH) > 12 mIU/ml; III) three or fewer oocytes retrieved in the previous IVF cycle; IV) low estradiol levels on the day of human chorionic gonadotropin (hCG) administration (< 1500 pmol/ml).
Key exclusion criteria (6 listed)
- body mass index > 30
- biochemical and ultrasound evidence of polycystic ovary syndrome
- stage III-IV endometriosis
- inflammatory or autoimmune disorders
- metabolic 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 |
|---|---|---|
| Long acting FSH and GnRH antagonistWoman in long acting FSH and GnRH antagonist arm receive an initial dose of 150 mcg Corifollitropin alfa on second day of the menstrual cycle followed by a fixed daily dose of 0.25 mg of GnRH antagonist on day 7 of the cycle onwards. On the ninth day of the cycle, a daily fixed dose of 300 IU of recombinant FSH will be administered until the day of ovulation triggering. | Drug | Long acting FSH and GnrH antagonist |
| Daily FSH and GnRH antagonistWoman in daily FSH and GnRH antagonist arm receive a fixed dose of 300 IU of recombinantFSH starting 3 day of the menstrual cycle followed by a fixed daily dose of 0.25 mg of GnRH antagonist on day 7 of the cycle onwards until the day of ovulation triggering. | Drug | daily FSH and GnRH antagonist |
| Triptorelin and recombinant FSHWomen in Triptorelin and recombinant FSH arm receive a fixed dose of 0.05 mg of Triprorelin from the 1 day of the menstrual cycle followed by a fixed dose of 300 IU of recombinant FSH starting 3 day untill the day of HCG administration. | Drug | Triptorelin and recombinant FSH |
Primary outcome
Clinical pregnancy rate
Time frame: Time Frame: until 12th gestational week
1 secondary outcome
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 25 Feb 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.
Mauro Schimberni, MD principal investigator
Bioroma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Long acting FSH and GnRH antagonist, Daily FSH and GnRH antagonist and Triptorelin and recombinant FSH in people with Female Infertility and Poor Responder, 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 1 inclusion and 6 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 25 Feb 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Clinical pregnancy rate (time frame: Time Frame: until 12th gestational week). 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 25 Feb 2014.