In Vitro FertilizationPhase 4NCT01816789
Age Versus Ovarian Reserve Markers Based Therapy in IVF (IVF)/Intracytoplasmic Sperm Injection (ICSI) Cycles
A Phase 4 study testing rFSH and buserelin in people with In Vitro Fertilization and Ovarian Stimulation, run by Andros Day Surgery Clinic at 1 site in Italy.
Trial summary
This randomized controlled trial has been designed for carrying out a comparison of new AMH (Anti-Müllerian Hormone)-based individualized treatment (using a nomogram) with the wide accepted age-based strategy. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- In Vitro Fertilization, Ovarian Stimulation
- What is being tested?
- rFSH and buserelin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2013to Jul 2016
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- first or second IVF/ICSI attempt (the second one after 6 months from the first one);regular menstrual cycles (25-33 days);female age ≤ 40; day 3 FSH ≤ 15IU/L;treatment with a long GnRH agonist protocol (buserelin)+rFSH;BMI: >18 and ≤ 25 kg/m2;presence of both ovaries.
Who cannot join
- irregular cycles, anovulatory infertility, endometriosis III-IV stage AFS, use of adjunctive therapies for stimulation, evidence of PCO status, previous ovarian surgery, presence of ovarian cysts, history of PID, use of hormonal contraception in the previous 3 months, any known metabolic or endocrinological disease, AMH levels < 1 and > 4.0 ng/ml
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Age Versus Ovarian Reserve Markers Based Therapy in IN Vitro Fertilization
This randomized controlled trial has been designed for carrying out a comparison of new AMH (Anti-Müllerian Hormone)-based individualized treatment (using a nomogram) with the wide accepted age-based strategy. The main objective of the trial is to assess whether an individualized FSH starting dose can increase the rate of women with an adequate ovarian response in terms of retrieved oocytes (optimal number of retrieved oocytes: 8-14).
Read the detailed description
Before clinicians can adopt any model into routine clinical practice, the accuracy of the model should be independently evaluated in a population different from the one on which the model was elaborated. External validation of the model is therefore crucial to assess the generalizability to other populations.
In the present RCT the new AMH-based individualized treatment will be compared to the wide accepted age-based strategy.
Primary endpoint:
The percentage of women with an appropriate number (n=8-14) of retrieved oocytes in IVF/ICSI cycle.
Secondary endpoints:
- Serum E2 levels on r-hCG day
- Serum P levels on r-hCG day
- Number of growing follicles (≥11mm) on r-hCG day
- Number of large (≥ 17 mm) ovarian follicles on r-hCG day
- Total r-FSH dose employed
- Treatment duration
- Rate of women with dose adjustment
- Number of cancelled cycles because of poor and hyper-response
- Fertilization rate
- Embryos obtained
- Implantation rates
- Biochemical pregnancy rates
- Clinical pregnancy rates
- OHSS rates
- Conditions
- In Vitro Fertilization, Ovarian Stimulation
- Being tested
- rFSH, buserelin
- Keywords
- Starting dose, rFSH, controlled, ovarian, stimulation, IVF/ICSI, cycles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rFSHDrug
buserelinDrug
| Study group | Role | What they receive |
|---|---|---|
| Group A: "age" | Active comparator | Group A: long standard protocol (buserelin 0.1 ml s.c. twice per day from the 21st day of the cycle, until the end of gonadotropin administration) + 150 IU of rFSH (starting dose) if female age was ≤35 years or 225 IU of rFSH if female age was ≥ 36 years. Receives: Drug: rFSH; Drug: buserelin |
| Group B: "nomogram" | Experimental | Group B: long standard protocol (buserelin 0.1 ml s.c. twice per day from the 21st day of the cycle until the end of gonadotropin administration) + individualized starting dose of rFSH on the basis of the nomogram. Receives: Drug: rFSH; Drug: buserelin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of women with an appropriate number (N=8-14) of retrieved oocytes in IVF/ICSI cycles
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionJul 2016
- Study completionJul 2016
Why it stopped: Optimal response: 63% nomogram, 42% controls, overcoming the stopping rule for interim analysis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for In Vitro FertilizationStudies 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, Investigator
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andros Day Surgery Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01816789
- Sponsor's protocol ID
- ANDROS-01-13
- Status last verified
- Oct 2016
- First submitted
- 20 Mar 2013
- Last updated
- 23 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Age Versus Ovarian Reserve Markers Based Therapy in IN Vitro Fertilization
- ClinicalTrials.gov ID
- NCT01816789
- Acronym / sponsor ID
- ANDROS-01-13
- Conditions
- In Vitro Fertilization, Ovarian Stimulation
- Keywords
- Starting dose, rFSH, controlled, ovarian, stimulation, IVF/ICSI, cycles
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Optimal response: 63% nomogram, 42% controls, overcoming the stopping rule for interim analysis
- Enrolment
- 194 participants (actual)
- Lead sponsor
- Andros Day Surgery ClinicUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 22 Mar 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.
This randomized controlled trial has been designed for carrying out a comparison of new AMH (Anti-Müllerian Hormone)-based individualized treatment (using a nomogram) with the wide accepted age-based strategy. The main objective of the trial is to assess whether an individualized FSH starting dose can increase the rate of women with an adequate ovarian response in terms of retrieved oocytes (optimal number of retrieved oocytes: 8-14).
Detailed description
Before clinicians can adopt any model into routine clinical practice, the accuracy of the model should be independently evaluated in a population different from the one on which the model was elaborated. External validation of the model is therefore crucial to assess the generalizability to other populations.
In the present RCT the new AMH-based individualized treatment will be compared to the wide accepted age-based strategy.
Primary endpoint:
The percentage of women with an appropriate number (n=8-14) of retrieved oocytes in IVF/ICSI cycle.
Secondary endpoints:
- Serum E2 levels on r-hCG day
- Serum P levels on r-hCG day
- Number of growing follicles (≥11mm) on r-hCG day
- Number of large (≥ 17 mm) ovarian follicles on r-hCG day
- Total r-FSH dose employed
- Treatment duration
- Rate of women with dose adjustment
- Number of cancelled cycles because of poor and hyper-response
- Fertilization rate
- Embryos obtained
- Implantation rates
- Biochemical pregnancy rates
- Clinical pregnancy rates
- OHSS rates
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: "age" | Active comparator | Drug: rFSH, Drug: buserelinGroup A: long standard protocol (buserelin 0.1 ml s.c. twice per day from the 21st day of the cycle, until the end of gonadotropin administration) + 150 IU of rFSH (starting dose) if female age was ≤35 years or 225 IU of rFSH if female age was ≥ 36 years. |
| Group B: "nomogram" | Experimental | Drug: rFSH, Drug: buserelinGroup B: long standard protocol (buserelin 0.1 ml s.c. twice per day from the 21st day of the cycle until the end of gonadotropin administration) + individualized starting dose of rFSH on the basis of the nomogram. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- first or second IVF/ICSI attempt (the second one after 6 months from the first one);regular menstrual cycles (25-33 days);female age ≤ 40; day 3 FSH ≤ 15IU/L;treatment with a long GnRH agonist protocol (buserelin)+rFSH;BMI: >18 and ≤ 25 kg/m2;presence of both ovaries.
Key exclusion criteria (1 listed)
- irregular cycles, anovulatory infertility, endometriosis III-IV stage AFS, use of adjunctive therapies for stimulation, evidence of PCO status, previous ovarian surgery, presence of ovarian cysts, history of PID, use of hormonal contraception in the previous 3 months, any known metabolic or endocrinological disease, AMH levels < 1 and > 4.0 ng/ml
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 |
|---|---|---|
| rFSH | Drug | Group A: "age", Group B: "nomogram" |
| buserelin | Drug | Group A: "age", Group B: "nomogram" |
Primary outcome
The percentage of women with an appropriate number (N=8-14) of retrieved oocytes in IVF/ICSI cycles
Time frame: 24 months
Results and safety
The study was stopped early (reason given: Optimal response: 63% nomogram, 42% controls, overcoming the stopping rule for interim analysis). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 rFSH and buserelin in people with In Vitro Fertilization and Ovarian Stimulation, run by Andros Day Surgery Clinic 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 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: stopped early, as of the sponsor's last update on 23 Dec 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 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?
The study was stopped early (reason given: Optimal response: 63% nomogram, 42% controls, overcoming the stopping rule for interim analysis). 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?
The percentage of women with an appropriate number (N=8-14) of retrieved oocytes in IVF/ICSI cycles (time frame: 24 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 23 Dec 2016.