Other Complications Associated With Artificial FertilizationPhase 3NCT02333253
Delayed Start Versus Conventional Antagonist Protocol in Poor Responders Pretreated by Estradiol in Luteal Phase
A Phase 3 study testing cetrotide in people with Other Complications Associated With Artificial Fertilization, run by Cairo University at 1 site in Egypt.
Trial summary
40 patients attending IVF center during 2013 \&2014 were fulfilling criteria of poor response and they failed to go through OPU as they gave <3 mature follicles on a dose of 300U GN or more. Read more about this study
- Who is it for?
- Ages 35 to 44 years, women only
- Conditions the study is for
- Other Complications Associated With Artificial Fertilization
- What is being tested?
- cetrotide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2015to Jan 2016
- 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 35 to 44 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 1 Poor responders 2. Age >35 years
Who cannot join
- patient >44ys ,
- AMH <0.3ng/ml,
- FSH >13, also
- patients of DM ,endometriosis ,general disease were excluded,
- any local uterine anomalies were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Delayed Start vs Conventional Antagonist Protocol in Poor Responders Pretreated by Estradiol in Luteal Phase.
40 patients attending IVF center during 2013 \&2014 were fulfilling criteria of poor response and they failed to go through OPU as they gave <3 mature follicles on a dose of 300U GN or more. All patients were revised for history, examinations and investigations, including age, type and duration of infertility, day 3 FSH, Day 3 E2, AMH, AFC.
Read the detailed description
40 patients attending IVF center during 2013 \&2014 were fulfilling criteria of poor response and they failed to go through OPU as they gave <3 mature follicles on a dose of 300U GN or more. All patients were revised for history, examinations and investigations, including age, type and duration of infertility, day 3 FSH, Day 3 E2, AMH, AFC All patients were 35 years old ore more We exclude patient >44ys ,AMH <0.3ng/ml,FSH >13, also patients of DM, endometriosis, general disease were excluded, any local uterine anomalies were excluded.
All patients received OCP for one cycle Then all had taken estradiol tablet 2 mg for one week prior to menses of the test cycle from Day 21 to day 28 Then we divide them into 2 groups US were done to exclude any cyst or follicle >10mm First group received 300 U r FSH +150 U urinary GN from day 2 till day of HCG,dose adjusted according to the response then 0.25 cetrotide S.c was added on when leading follicle reach >12 mm, HCG was given only if we have at least 3 mature follicles >14 mm and the leading one >17mm then OPU done after 36 hrs of HCG, oocytes were denuded and fertilized by ICSI to avoid low fertilization rate by conventional IVF,embryo transfer were done on day 3 when we have at least one embryo GI other wise cancelled ET, then cyclogest 800mg were given intravaginal for 14 days then quantitative BHCG done and considered positive if > 5miu/ML 28 day after ET, TVS was done to confirm ongoing pregnancy by visualization of IU sac.
Second group were received cetrotide 0.25 mg s.c alone from day 2 to day 8then we initiate GN therapy by same initial GN dose (300FSH+150U urinary GN).same adjustment of dose were done and antagonist restarted when DF >12mm, till day of HCG, HCG,OPU, ET were done by same method and under same criteria, luteal support and follow were the same.
- Being tested
- cetrotide
- Keywords
- poor responders, GnRH antagonist, Conventional protocol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cetrotideDrug
Also called cetrorelix acetate
0.25 cetrotide S.c was added on when leading follicle reach >12 mm
| Study group | Role | What they receive |
|---|---|---|
| Delayed start protocol | Active comparator | First group received 300 U r FSH +150 U urinary GN from day 2 till day of HCG ,dose adjusted according to the response then 0.25 cetrotide S.c was added on when leading follicle reach >12 mm, HCG was given only if we have at least 3 mature follicles >14 mm and the leading one >17mm then OPU done after 36 hrs of HCG, oocytes were denuded and fertilized by ICSI to avoid low fertilization rate by conventional IVF,embryo transfer were done on day 3 when we have at least one embryo GI other wise cancelled ET, then cyclogest 800mg were given intravaginal for 14 days then quantitative BHCG done and considered positive if > 5miu/ML Receives: Drug: cetrotide |
| conventional antagonist protocol | Active comparator | Second group were received cetrotide 0.25 mg s.c alone from day 2 to day 8then we initiate GN therapy by same initial GN dose (300FSH+150U urinary GN).same adjustment of dose were done and antagonist restarted when DF >12mm, till day of HCG, OPU done after 36 hrs of HCG, oocytes were denuded and fertilized by ICSI to avoid low fertilization rate by conventional IVF,embryo transfer were done on day 3 when we have at least one embryo GI other wise cancelled ET, then cyclogest 800mg were given intravaginal for 14 days then quantitative BHCG done and considered positive if > 5miu/ML Receives: Drug: cetrotide |
What is being measured
The primary outcome is the main question the study is designed to answer.
oocyte retrieved number
Measured: Induction cycle an expected average of 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Other Complications Associated With Artificial FertilizationStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Maged, Cairo University
- Investigators
- Ahmed M Maged, MD, Principal investigator, Kasr Alainy medical school
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02333253
- Sponsor's protocol ID
- 11
- Status last verified
- Jan 2016
- First submitted
- 2 Jan 2015
- Last updated
- 27 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delayed Start vs Conventional Antagonist Protocol in Poor Responders Pretreated by Estradiol in Luteal Phase.
- ClinicalTrials.gov ID
- NCT02333253
- Acronym / sponsor ID
- 11
- Keywords
- poor responders, GnRH antagonist, Conventional protocol
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 7 Jan 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.
40 patients attending IVF center during 2013 \&2014 were fulfilling criteria of poor response and they failed to go through OPU as they gave <3 mature follicles on a dose of 300U GN or more. All patients were revised for history, examinations and investigations, including age, type and duration of infertility, day 3 FSH, Day 3 E2, AMH, AFC.
Detailed description
40 patients attending IVF center during 2013 \&2014 were fulfilling criteria of poor response and they failed to go through OPU as they gave <3 mature follicles on a dose of 300U GN or more. All patients were revised for history, examinations and investigations, including age, type and duration of infertility, day 3 FSH, Day 3 E2, AMH, AFC All patients were 35 years old ore more We exclude patient >44ys ,AMH <0.3ng/ml,FSH >13, also patients of DM, endometriosis, general disease were excluded, any local uterine anomalies were excluded.
All patients received OCP for one cycle Then all had taken estradiol tablet 2 mg for one week prior to menses of the test cycle from Day 21 to day 28 Then we divide them into 2 groups US were done to exclude any cyst or follicle >10mm First group received 300 U r FSH +150 U urinary GN from day 2 till day of HCG,dose adjusted according to the response then 0.25 cetrotide S.c was added on when leading follicle reach >12 mm, HCG was given only if we have at least 3 mature follicles >14 mm and the leading one >17mm then OPU done after 36 hrs of HCG, oocytes were denuded and fertilized by ICSI to avoid low fertilization rate by conventional IVF,embryo transfer were done on day 3 when we have at least one embryo GI other wise cancelled ET, then cyclogest 800mg were given intravaginal for 14 days then quantitative BHCG done and considered positive if > 5miu/ML 28 day after ET, TVS was done to confirm ongoing pregnancy by visualization of IU sac.
Second group were received cetrotide 0.25 mg s.c alone from day 2 to day 8then we initiate GN therapy by same initial GN dose (300FSH+150U urinary GN).same adjustment of dose were done and antagonist restarted when DF >12mm, till day of HCG, HCG,OPU, ET were done by same method and under same criteria, luteal support and follow were the same.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Delayed start protocol | Active comparator | Drug: cetrotideFirst group received 300 U r FSH +150 U urinary GN from day 2 till day of HCG ,dose adjusted according to the response then 0.25 cetrotide S.c was added on when leading follicle reach >12 mm, HCG was given only if we have at least 3 mature follicles >14 mm and the leading one >17mm then OPU done after 36 hrs of HCG, oocytes were denuded and fertilized by ICSI to avoid low fertilization rate by conventional IVF,embryo transfer were done on day 3 when we have at least one embryo GI other wise cancelled ET, then cyclogest 800mg were given intravaginal for 14 days then quantitative BHCG done and considered positive if > 5miu/ML |
| conventional antagonist protocol | Active comparator | Drug: cetrotideSecond group were received cetrotide 0.25 mg s.c alone from day 2 to day 8then we initiate GN therapy by same initial GN dose (300FSH+150U urinary GN).same adjustment of dose were done and antagonist restarted when DF >12mm, till day of HCG, OPU done after 36 hrs of HCG, oocytes were denuded and fertilized by ICSI to avoid low fertilization rate by conventional IVF,embryo transfer were done on day 3 when we have at least one embryo GI other wise cancelled ET, then cyclogest 800mg were given intravaginal for 14 days then quantitative BHCG done and considered positive if > 5miu/ML |
Who may qualify
- Ages
- 35 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1 Poor responders 2. Age >35 years
Key exclusion criteria (5 listed)
- patient >44ys ,
- AMH <0.3ng/ml,
- FSH >13, also
- patients of DM ,endometriosis ,general disease were excluded,
- any local uterine anomalies were excluded.
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 |
|---|---|---|
| cetrotideAlso: cetrorelix acetate0.25 cetrotide S.c was added on when leading follicle reach >12 mm | Drug | Delayed start protocol, conventional antagonist protocol |
Primary outcome
oocyte retrieved number
Time frame: Induction cycle an expected average of 4 weeks
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 Jan 2016.
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.
Ahmed M Maged, MD principal investigator
Kasr Alainy medical school
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 cetrotide in people with Other Complications Associated With Artificial Fertilization, run by Cairo University at 1 site in Egypt.
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 5 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 Jan 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 Egypt. 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?
oocyte retrieved number (time frame: Induction cycle an expected average of 4 weeks). 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 27 Jan 2016.