InfertilityNCT01887652
Individualization of Ovarian Stimulation Using AMH Maximizes the Benefits and Minimizes Complications and Risks
A study testing conventional ovarian stimulation and individualized ovarian stimulation in people with Infertility, run by ANDROFERT - Clinica de Andrologia e Reproducao Humana at 1 site in Brazil.
Trial summary
The purpose oh the study is to determine the usefulness of anti-Mullerian hormone (AMH) to identify women at risk of excessive and poor response in controlled ovarian stimulation (COS) for in vitro fertilization (IVF), and the clinical impact of applying individualized COS strategies in these subsets of patients. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Infertility
- What is being tested?
- conventional ovarian stimulation and individualized ovarian stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2012to Jul 2013
- Phase
- Interventional
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- women with in vitro fertilization treatment indication
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Individualization of Controlled Ovarian Stimulation Using Anti-mullerian Hormone as a Biomarker of Ovarian Response Maximizes the Beneficial Effects of Treatment and Minimizes Complications and Risks.
The purpose oh the study is to determine the usefulness of anti-Mullerian hormone (AMH) to identify women at risk of excessive and poor response in controlled ovarian stimulation (COS) for in vitro fertilization (IVF), and the clinical impact of applying individualized COS strategies in these subsets of patients.
Read the detailed description
A group of 130 women undergoing conventional COS after pituitary down-regulation for IVF will be studied to determine the best cut-off points of AMH, using receiver operating characteristic (ROC) analysis, to discriminate excessive (≥20 oocytes retrieved) and poor response (≤4 oocytes retrieved). The inclusion criteria is any patient with indication of IVF treatment. Subsequently, a different group of 120 women (with the same criteria) will be assessed using AMH before starting COS, and treatment strategy will be individualized according to AMH results (iCOS). Mild stimulation using daily doses (112.5 to 150 IU) of recombinant follicle stimulation hormone (rec-hFSH) or rec-hFSH combined with recombinant luteinizing hormone (LH) supplementation (375 IU total daily dose) will be given to patients identified as at risk of excessive and poor response, respectively. It will evaluated: number of oocytes, clinical pregnancy rates (defined as fetal heartbeat on ultrasound performed 4 weeks after the transfer of embryos) and occurrence of Ovarian hyperstimulation syndrome). Outcomes will be compared between the groups who received conventional and iCOS using chi-square and Fisher exact tests.
- Conditions
- Infertility
- Being tested
- conventional ovarian stimulation, individualized ovarian stimulation
- Keywords
- In Vitro Fertilization, ovulation induction, anti-mullerian hormone
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional ovarian stimulationOther
a protocol of ovarian stimulation with recombinant FSH with dose according to age, ovarian size and previous treatment. In patients alder than 35, recombinant LH was added to ovarian stimulation.
individualized ovarian stimulationOther
After defining cut-off points of anti-mullerian hormone, using a ROC analysis, to discriminate excessive (≥20 oocytes retrieved) and poor response (≤4 oocytes retrieved), a individualized protocol was defined.Mild stimulation using daily doses (112.5 to 150 IU) of recombinant FSH or recombinant FSH combined with recombinant LH supplementation (375 IU total daily dose) were given to patients identified as at risk of excessive and poor response.
| Study group | Role | What they receive |
|---|---|---|
| conventional ovarian stimulation | Active comparator | women whose protocol of ovarian stimulation was based on age, ovarian size and previous treatment Receives: Other: conventional ovarian stimulation |
| individualized ovarian stimulation | Active comparator | women whose protocol of ovarian stimulation was based on anti-mullerian hormone Receives: Other: individualized ovarian stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of oocytes retrieved
number of oocyte retrieved classified as: poor response: ≤4 oocytes normal response: 5 - 19 oocytes excessive response: ≥20 oocytes
Measured: 1 day (on the day of oocyte retrieval)
Secondary outcomes (3)
clinical pregnancy rate
presence of fetal heartbeat on transvaginal ultrasound
Measured: 4 weeks after embryo transfer
occurrence of ovarian hyperstimulation syndrome
presence of hyperstimulation syndrome during follow up after oocyte retrieval
Measured: 4 weeks after embryo transfer
cancellation
cancellation of the cycle because of no ovarian response (no follicles >14 mm during ovarian stimulation)
Measured: on the 8th day of ovarian stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2013 (estimated)
- Study startMar 2012
- Primary completionJun 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- ANDROFERT - Clinica de Andrologia e Reproducao Humana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rogerio BF Leao, MD, Principal investigator, ANDROFERT - Clinica de Andrologia e Reproducao HumanaSandro C Esteves, PhD, Study director, ANDROFERT - Clinica de Andrologia e Reproducao HumanaFabiana Y Nakano, Study chair, ANDROFERT - Clinica de Andrologia e Reproducao Humana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01887652
- Sponsor's protocol ID
- ANDRO-03-12
- Status last verified
- Jun 2014
- First submitted
- 24 Jun 2013
- Last updated
- 26 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualization of Controlled Ovarian Stimulation Using Anti-mullerian Hormone as a Biomarker of Ovarian Response Maximizes the Beneficial Effects of Treatment and Minimizes Complications and Risks.
- ClinicalTrials.gov ID
- NCT01887652
- Acronym / sponsor ID
- ANDRO-03-12
- Conditions
- Infertility
- Keywords
- In Vitro Fertilization, ovulation induction, anti-mullerian hormone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- ANDROFERT - Clinica de Andrologia e Reproducao HumanaUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 27 Jun 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 purpose oh the study is to determine the usefulness of anti-Mullerian hormone (AMH) to identify women at risk of excessive and poor response in controlled ovarian stimulation (COS) for in vitro fertilization (IVF), and the clinical impact of applying individualized COS strategies in these subsets of patients.
Detailed description
A group of 130 women undergoing conventional COS after pituitary down-regulation for IVF will be studied to determine the best cut-off points of AMH, using receiver operating characteristic (ROC) analysis, to discriminate excessive (≥20 oocytes retrieved) and poor response (≤4 oocytes retrieved). The inclusion criteria is any patient with indication of IVF treatment. Subsequently, a different group of 120 women (with the same criteria) will be assessed using AMH before starting COS, and treatment strategy will be individualized according to AMH results (iCOS). Mild stimulation using daily doses (112.5 to 150 IU) of recombinant follicle stimulation hormone (rec-hFSH) or rec-hFSH combined with recombinant luteinizing hormone (LH) supplementation (375 IU total daily dose) will be given to patients identified as at risk of excessive and poor response, respectively. It will evaluated: number of oocytes, clinical pregnancy rates (defined as fetal heartbeat on ultrasound performed 4 weeks after the transfer of embryos) and occurrence of Ovarian hyperstimulation syndrome). Outcomes will be compared between the groups who received conventional and iCOS using chi-square and Fisher exact tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional ovarian stimulation | Active comparator | Other: conventional ovarian stimulationwomen whose protocol of ovarian stimulation was based on age, ovarian size and previous treatment |
| individualized ovarian stimulation | Active comparator | Other: individualized ovarian stimulationwomen whose protocol of ovarian stimulation was based on anti-mullerian hormone |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- women with in vitro fertilization treatment indication
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| conventional ovarian stimulationa protocol of ovarian stimulation with recombinant FSH with dose according to age, ovarian size and previous treatment. In patients alder than 35, recombinant LH was added to ovarian stimulation. | Other | conventional ovarian stimulation |
| individualized ovarian stimulationAfter defining cut-off points of anti-mullerian hormone, using a ROC analysis, to discriminate excessive (≥20 oocytes retrieved) and poor response (≤4 oocytes retrieved), a individualized protocol was defined.Mild stimulation using daily doses (112.5 to 150 IU) of recombinant FSH or recombinant FSH combined with recombinant LH supplementation (375 IU total daily dose) were given to patients identified as at risk of excessive and poor response. | Other | individualized ovarian stimulation |
Primary outcome
number of oocytes retrieved
Time frame: 1 day (on the day of oocyte retrieval)
number of oocyte retrieved classified as: poor response: ≤4 oocytes normal response: 5 - 19 oocytes excessive response: ≥20 oocytes
3 secondary outcomes
clinical pregnancy rate
Time frame: 4 weeks after embryo transfer
occurrence of ovarian hyperstimulation syndrome
Time frame: 4 weeks after embryo transfer
cancellation
Time frame: on the 8th day of ovarian stimulation
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 26 Jun 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.
Rogerio BF Leao, MD principal investigator
ANDROFERT - Clinica de Andrologia e Reproducao Humana
Sandro C Esteves, PhD study director
ANDROFERT - Clinica de Andrologia e Reproducao Humana
Fabiana Y Nakano study chair
ANDROFERT - Clinica de Andrologia e Reproducao Humana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing conventional ovarian stimulation and individualized ovarian stimulation in people with Infertility, run by ANDROFERT - Clinica de Andrologia e Reproducao Humana at 1 site in Brazil.
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: finished, as of the sponsor's last update on 26 Jun 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 Brazil. 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?
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?
number of oocytes retrieved (time frame: 1 day (on the day of oocyte retrieval)). 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 26 Jun 2014.