Poor Responders Undergoing IVFPhase 4NCT01948804
The Comparison of Effect of Four Different Treatment Protocols on IVF Outcomes in Poor Responders Undergoing in Vitro Fertilization.
A Phase 4 study testing GnrH Antagonist/letrozole protocol (Cetrotide; serono + Femara; Novartis Pharma AG), microdose flare-up protocol (Lucrin; Abbott + Gonal F, Serono) and Antagonist/clomiphene protocol (Cetrotide; serono + Klomen, Kocak pharma) in people with Poor Responders Undergoing IVF, run by Pınar Özcan Cenksoy.
Trial summary
The comparison of effect of four different treatment protocols: Antagonist/letrozole protocol, microdose flare-up protocol, Antagonist/clomiphene protocol, Antagonist on IVF outcomes in poor responders undergoing in vitro fertilization; a prospective randomized-controlled study. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Poor Responders Undergoing IVF
- What is being tested?
- GnrH Antagonist/letrozole protocol (Cetrotide; serono + Femara; Novartis Pharma AG), microdose flare-up protocol (Lucrin; Abbott + Gonal F, Serono) and Antagonist/clomiphene protocol (Cetrotide; serono + Klomen, Kocak pharma)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Mar 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 18 to 44 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Criteria for definition of poor responders included at least one of the following
- Anti müllerian hormone <1.1 ng/ml and/or a previous poor ovarian response (≤3 oocytes with a conventional stimulation protocol).
- Primary infertile patients
- BMI≤30 kg/m2 were included this study.
Who cannot join
- -
About this study
Official title: The Comparison of Effect of Four Different Treatment Protocols: Antagonist/Letrozole Protocol, Microdose Flare-up Protocol, Antagonist/Clomiphene Protocol, Antagonist on IVF Outcomes in Poor Responders Undergoing in Vitro Fertilization; a Prospective Randomized-controlled Study.
The comparison of effect of four different treatment protocols: Antagonist/letrozole protocol, microdose flare-up protocol, Antagonist/clomiphene protocol, Antagonist on IVF outcomes in poor responders undergoing in vitro fertilization; a prospective randomized-controlled study.
- Conditions
- Poor Responders Undergoing IVF
- Being tested
- GnrH Antagonist/letrozole protocol (Cetrotide; serono + Femara; Novartis Pharma AG), microdose flare-up protocol (Lucrin; Abbott + Gonal F, Serono), Antagonist/clomiphene protocol (Cetrotide; serono + Klomen, Kocak pharma), GnRH antagonist protocol (Cetrotide, Serono)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GnrH Antagonist/letrozole protocol (Cetrotide; serono + Femara; Novartis Pharma AG)Drug
microdose flare-up protocol (Lucrin; Abbott + Gonal F, Serono)Drug
Antagonist/clomiphene protocol (Cetrotide; serono + Klomen, Kocak pharma)Drug
GnRH antagonist protocol (Cetrotide, Serono)Drug
| Study group | Role | What they receive |
|---|---|---|
| IVF patients | Experimental | patients that has applied to Yeditepe University Hospital assisted reproduction center Receives: Drug: GnrH Antagonist/letrozole protocol (Cetrotide; serono + Femara; Novartis Pharma AG); Drug: microdose flare-up protocol (Lucrin; Abbott + Gonal F, Serono); Drug: Antagonist/clomiphene protocol (Cetrotide; serono + Klomen, Kocak pharma); Drug: GnRH antagonist protocol (Cetrotide, Serono) |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical pregnancy rates
Measured: 6 months
Secondary outcomes (1)
total number of oocytes retrieved
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 posted24 Sep 2013 (estimated)
- Study startJan 2014
- Primary completionMar 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Poor Responders Undergoing IVFStudies 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pınar Özcan Cenksoy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Pınar Özcan Cenksoy, Yeditepe University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01948804
- Sponsor's protocol ID
- ytu-123
- Other IDs
- ytu-123
- Status last verified
- Jan 2014
- First submitted
- 6 Sep 2013
- Last updated
- 15 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of Effect of Four Different Treatment Protocols: Antagonist/Letrozole Protocol, Microdose Flare-up Protocol, Antagonist/Clomiphene Protocol, Antagonist on IVF Outcomes in Poor Responders Undergoing in Vitro Fertilization; a Prospective Randomized-controlled Study.
- ClinicalTrials.gov ID
- NCT01948804
- Acronym / sponsor ID
- ytu-123
- Conditions
- Poor Responders Undergoing IVF
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Pınar Özcan CenksoyUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Mar 2014 (estimated)
- First posted
- 24 Sep 2013 (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 comparison of effect of four different treatment protocols: Antagonist/letrozole protocol, microdose flare-up protocol, Antagonist/clomiphene protocol, Antagonist on IVF outcomes in poor responders undergoing in vitro fertilization; a prospective randomized-controlled study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IVF patients | Experimental | Drug: GnrH Antagonist/letrozole protocol (Cetrotide; serono + Femara; Novartis Pharma AG), Drug: microdose flare-up protocol (Lucrin; Abbott + Gonal F, Serono), Drug: Antagonist/clomiphene protocol (Cetrotide; serono + Klomen, Kocak pharma), Drug: GnRH antagonist protocol (Cetrotide, Serono)patients that has applied to Yeditepe University Hospital assisted reproduction center |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Criteria for definition of poor responders included at least one of the following
- Anti müllerian hormone <1.1 ng/ml and/or a previous poor ovarian response (≤3 oocytes with a conventional stimulation protocol).
- Primary infertile patients
- BMI≤30 kg/m2 were included this study.
Key exclusion criteria (1 listed)
- -
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/letrozole protocol (Cetrotide; serono + Femara; Novartis Pharma AG) | Drug | IVF patients |
| microdose flare-up protocol (Lucrin; Abbott + Gonal F, Serono) | Drug | IVF patients |
| Antagonist/clomiphene protocol (Cetrotide; serono + Klomen, Kocak pharma) | Drug | IVF patients |
| GnRH antagonist protocol (Cetrotide, Serono) | Drug | IVF patients |
Primary outcome
clinical pregnancy rates
Time frame: 6 months
1 secondary outcome
total number of oocytes retrieved
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2014.
Related trials for Poor Responders Undergoing IVF
Not yet recruitingPhase 1/2
Drospirenone-Primed Ovarian Stimulation Versus GnRH Antagonist Protocol in Poor Ovarian Responders Undergoing Freeze-All IVF/ICSI
Poor Ovarian Reserve, Infertility (IVF Patients)
RecruitingPhase 2
Dydrogesterone Versus GnRH Antagonist in Poor Responders Undergoing Double Ovarian Stimulation
Infertility
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing GnrH Antagonist/letrozole protocol (Cetrotide; serono + Femara; Novartis Pharma AG), microdose flare-up protocol (Lucrin; Abbott + Gonal F, Serono) and Antagonist/clomiphene protocol (Cetrotide; serono + Klomen, Kocak pharma) in people with Poor Responders Undergoing IVF, run by Pınar Özcan Cenksoy.
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 4 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 15 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
clinical pregnancy rates (time frame: 6 months). 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 15 Jan 2014.