InfertilityPhase 4NCT00334243
Protocols for Improved in Vitro Fertilization (IVF) Outcomes
A Phase 4 study testing Microflare protocol for IVF, Antagonist protocol for IVF and Demi-halt protocol for IVF in people with Infertility, run by University of California, San Francisco at 1 site in United States.
Trial summary
Many infertile patients have a decreased chance of becoming pregnant when using in vitro fertilization (IVF). For these patients, many different treatments are available, but none of them have been shown to be better than the others. We are testing which of three different treatments are better than the others. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Microflare protocol for IVF, Antagonist protocol for IVF and Demi-halt protocol for IVF
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Nov 2007
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Infertile patients
- Undergoing IVF
- Antral Follicle Count Less than 10
- Prior history of less than 5 oocytes generated during an IVF cycle
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94115
About this study
Official title: Protocol Evaluation for Improved In Vitro Fertilization Outcomes
Many infertile patients have a decreased chance of becoming pregnant when using in vitro fertilization (IVF). For these patients, many different treatments are available, but none of them have been shown to be better than the others. We are testing which of three different treatments are better than the others. Patients who are expected to have a decreased response to ovarian stimulation will be randomized to either a microflare protocol, an antagonist protocol, or a demi-halt protocol.
Read the detailed description
Infertile patients with an anticipated poor response to ovarian stimulation will be randomized to one of three different protocols in their upcoming IVF cycle. Each of the protocols will be performed as is the standard of care with the addition of serum evaluation during the course of the stimulation as well as follicular fluid analysis which is obtained as a byproduct of the oocyte retrieval. Chart review will be performed to collect background characteristics (including age, ethnicity, previous fertility treatment), treatment response (such as oocyte number, embryo grade, embryo quality), and pregnancy outcome (such as miscarriage, singleton pregnancy, or higher-order multiple pregnancy). Statistical analysis will be performed to determine if one protocol leads to higher pregnancy rates and multivariate analysis will be performed to determine potential etiologic variables.
- Conditions
- Infertility
- Being tested
- Microflare protocol for IVF, Antagonist protocol for IVF, Demi-halt protocol for IVF
- Keywords
- in vitro fertilization, infertile, infertility, pregnancy, pregnancy rates, microflare protocol, antagonist protocol, demi-halt protocol, poor responders, low antral follicle count, Infertile Patients undergoing in vitro fertilization (IVF), Patients with a previous poor response to ovarian stimulation, Patients with an antral follicle count of less than 10
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microflare protocol for IVFDrug
Antagonist protocol for IVFDrug
Demi-halt protocol for IVFDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy Rate
Secondary outcomes (5)
Cycle Cancellation Rates
Number of Oocytes Generated
Number of Embryos Generated
Serum hormonal evaluation
Follicular fluid evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2006 (estimated)
- Study startJun 2006
- Primary completionAug 2007
- Study completionNov 2007
Why it stopped: stopped due to limited enrollment. 2 subjects were enrolled. There was NO enrollment after November 2007.
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.
- More trials run by University of California, San FranciscoThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marcelle I Cedars, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00334243
- Sponsor's protocol ID
- Purcell-01
- Status last verified
- Oct 2011
- First submitted
- 6 Jun 2006
- Last updated
- 6 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol Evaluation for Improved In Vitro Fertilization Outcomes
- ClinicalTrials.gov ID
- NCT00334243
- Acronym / sponsor ID
- Purcell-01
- Conditions
- Infertility
- Keywords
- in vitro fertilization, infertile, infertility, pregnancy, pregnancy rates, microflare protocol, antagonist protocol, demi-halt protocol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: stopped due to limited enrollment. 2 subjects were enrolled. There was NO enrollment after November 2007.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Jun 2006
- Primary completion
- Aug 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 7 Jun 2006 (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.
Many infertile patients have a decreased chance of becoming pregnant when using in vitro fertilization (IVF). For these patients, many different treatments are available, but none of them have been shown to be better than the others. We are testing which of three different treatments are better than the others. Patients who are expected to have a decreased response to ovarian stimulation will be randomized to either a microflare protocol, an antagonist protocol, or a demi-halt protocol.
Detailed description
Infertile patients with an anticipated poor response to ovarian stimulation will be randomized to one of three different protocols in their upcoming IVF cycle. Each of the protocols will be performed as is the standard of care with the addition of serum evaluation during the course of the stimulation as well as follicular fluid analysis which is obtained as a byproduct of the oocyte retrieval. Chart review will be performed to collect background characteristics (including age, ethnicity, previous fertility treatment), treatment response (such as oocyte number, embryo grade, embryo quality), and pregnancy outcome (such as miscarriage, singleton pregnancy, or higher-order multiple pregnancy). Statistical analysis will be performed to determine if one protocol leads to higher pregnancy rates and multivariate analysis will be performed to determine potential etiologic variables.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Infertile patients
- Undergoing IVF
- Antral Follicle Count Less than 10
- Prior history of less than 5 oocytes generated during an IVF cycle
Key exclusion criteria (0 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 |
|---|---|---|
| Microflare protocol for IVF | Drug | – |
| Antagonist protocol for IVF | Drug | – |
| Demi-halt protocol for IVF | Drug | – |
Primary outcome
Pregnancy Rate
5 secondary outcomes
Cycle Cancellation Rates
Number of Oocytes Generated
Number of Embryos Generated
Serum hormonal evaluation
Follicular fluid evaluation
Results and safety
The study was stopped early (reason given: stopped due to limited enrollment. 2 subjects were enrolled. There was NO enrollment after November 2007.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2011.
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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.
Marcelle I Cedars, MD principal investigator
University of California, San Francisco
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 Microflare protocol for IVF, Antagonist protocol for IVF and Demi-halt protocol for IVF in people with Infertility, run by University of California, San Francisco at 1 site in United States.
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 0 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 6 Oct 2011. 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 United States. 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: stopped due to limited enrollment. 2 subjects were enrolled. There was NO enrollment after November 2007.). 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?
Pregnancy Rate. 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 6 Oct 2011; AzTrials last refreshed its copy on 29 Oct 2026.