FertilizationNCT01558141
Follicular Flushing
A study testing Aspiration without flushing follicles with culture media and Follicular Flushing in people with Fertilization, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
Patients with infertility often undergo in vitro fertilization (IVF) to achieve a pregnancy, which involves ovarian stimulation, monitoring of follicular growth, oocyte retrieval, sperm insemination, embryo culture and embryo transfer. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Fertilization
- What is being tested?
- Aspiration without flushing follicles with culture media and Follicular Flushing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to May 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 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pts ages 18-45 undergoing IVF
- Pts with ≤ 4 follicles that are ≥ 12mm on day of HCG
Who cannot join
- Pts undergoing natural cycles (i.e. those with intentionally low # of follicles)
Trial locations and contacts
1 site in 1 country.
United States1 site
New York Presbyterian Hospital
New York, New York, 10065
About this study
Official title: Follicular Flushing on Cycle Outcomes in Poor Responders
Patients with infertility often undergo in vitro fertilization (IVF) to achieve a pregnancy, which involves ovarian stimulation, monitoring of follicular growth, oocyte retrieval, sperm insemination, embryo culture and embryo transfer.
The oocytes are removed during surgery by aspirating the follicles using a single lumen needle with an ultrasound to guide the procedure. There is some data that flushing the follicles with embryo culture media before aspiration using a double lumen needle increases the number of oocytes retrieved, particularly among poor responding patients for whom each additional oocyte recovered may substantially alter the outcome of that IVF cycle.
The objective of the research is to evaluate the effect of follicular flushing in poor responders on IVF cycle outcomes.
Read the detailed description
Patients with infertility often undergo in vitro fertilization (IVF) to achieve a pregnancy, which involves ovarian stimulation, monitoring of follicular growth, oocyte retrieval, sperm insemination, embryo culture and embryo transfer. The number of embryos obtained is dependent on the number of oocytes retrieved.
The objective of the research is to evaluate the effect of follicular flushing in poor responders on IVF cycle outcomes, including the number of oocytes retrieved, number of mature oocytes, fertilization rate, number of embryos transferred, implantation rate, miscarriage rate, live birth rate, operating room time, and luteal estradiol and progesterone levels.
The research entails a prospective, randomized, controlled trial of poor-responder patients who are undergoing IVF treatment at The Ronald O. Perelman and Claudia Cohen Center for Reproductive Medicine, defined as patients who have ≤ 4 follicles that are ≥ 12mm on the day of hCG trigger.
Patients identified as poor responders will be consented and randomized to follicular flushing versus aspiration without flushing. A 2-5mL flush using embryo culture media followed by aspiration of the follicle will be performed in the patients randomized to the flushing group, with subsequent flushes until an oocyte is identified or up to 4 flushes maximum.
Patients being enrolled in this research study will undergo IVF regardless of participation in this research study.
Randomization:
A series of randomized blocks of 2 will be generated for the study. This will provide assurance that after two patients are enrolled, there will be one patient assigned to each group- follicular flushing versus aspiration without flushing. This process of blocked randomization ensures an equal distribution between the two study arms of patients.
- Conditions
- Fertilization
- Being tested
- Aspiration without flushing follicles with culture media, Follicular Flushing
- Keywords
- IVF stimulation., Poor responders., IVF patients with poor response to stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aspiration without flushing follicles with culture mediaOther
Aspiration without flushing follicles with culture media.
Follicular FlushingOther
Flushing follicles with embryo culture media prior to aspiration.
| Study group | Role | What they receive |
|---|---|---|
| Follicular flushing | Active comparator | Flushing follicles with embryo culture media prior to aspiration. Receives: Other: Aspiration without flushing follicles with culture media; Other: Follicular Flushing |
What is being measured
The primary outcome is the main question the study is designed to answer.
FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS
To evaluate the number of oocytes retrieved with follicular flushing in poor responders
Measured: 2 weeks
Secondary outcomes (8)
FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS
To evaluate:
- # of embryos transferred
Measured: 2 weeks
FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS
Fertilization rates.
Measured: 2 weeks
FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS
Implantation rates
Measured: 2 weeks
FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS
Pregnancy rates
Measured: 2 weeks
FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS
Live birth rates
Measured: 2 weeks
FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS
Operating room anesthesia time.
Measured: 2 weeks
FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS
Luteal E2 level.
Measured: 2 weeks
FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS
Luteal P4 level.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2012 (estimated)
- Study startSep 2011
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven D. Spandorfer, MD, Principal investigator, Weill Medical College of Cornell
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01558141
- Sponsor's protocol ID
- 1108011882
- Status last verified
- Jun 2015
- First submitted
- 16 Feb 2012
- Last updated
- 14 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Mok-Lin E, Brauer AA, Schattman G, Zaninovic N, Rosenwaks Z, Spandorfer S. Follicular flushing and in vitro fertilization outcomes in the poorest responders: a randomized controlled trial. Hum Reprod. 2013 Nov;28(11):2990-5. doi: 10.1093/humrep/det350. Epub 2013 Sep 5.
PubMed 24014603
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follicular Flushing on Cycle Outcomes in Poor Responders
- ClinicalTrials.gov ID
- NCT01558141
- Acronym / sponsor ID
- 1108011882
- Conditions
- Fertilization
- Keywords
- IVF stimulation., Poor responders., IVF patients with poor response to stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 20 Mar 2012 (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.
Patients with infertility often undergo in vitro fertilization (IVF) to achieve a pregnancy, which involves ovarian stimulation, monitoring of follicular growth, oocyte retrieval, sperm insemination, embryo culture and embryo transfer.
The oocytes are removed during surgery by aspirating the follicles using a single lumen needle with an ultrasound to guide the procedure. There is some data that flushing the follicles with embryo culture media before aspiration using a double lumen needle increases the number of oocytes retrieved, particularly among poor responding patients for whom each additional oocyte recovered may substantially alter the outcome of that IVF cycle.
The objective of the research is to evaluate the effect of follicular flushing in poor responders on IVF cycle outcomes.
Detailed description
Patients with infertility often undergo in vitro fertilization (IVF) to achieve a pregnancy, which involves ovarian stimulation, monitoring of follicular growth, oocyte retrieval, sperm insemination, embryo culture and embryo transfer. The number of embryos obtained is dependent on the number of oocytes retrieved.
The objective of the research is to evaluate the effect of follicular flushing in poor responders on IVF cycle outcomes, including the number of oocytes retrieved, number of mature oocytes, fertilization rate, number of embryos transferred, implantation rate, miscarriage rate, live birth rate, operating room time, and luteal estradiol and progesterone levels.
The research entails a prospective, randomized, controlled trial of poor-responder patients who are undergoing IVF treatment at The Ronald O. Perelman and Claudia Cohen Center for Reproductive Medicine, defined as patients who have ≤ 4 follicles that are ≥ 12mm on the day of hCG trigger.
Patients identified as poor responders will be consented and randomized to follicular flushing versus aspiration without flushing. A 2-5mL flush using embryo culture media followed by aspiration of the follicle will be performed in the patients randomized to the flushing group, with subsequent flushes until an oocyte is identified or up to 4 flushes maximum.
Patients being enrolled in this research study will undergo IVF regardless of participation in this research study.
Randomization:
A series of randomized blocks of 2 will be generated for the study. This will provide assurance that after two patients are enrolled, there will be one patient assigned to each group- follicular flushing versus aspiration without flushing. This process of blocked randomization ensures an equal distribution between the two study arms of patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Follicular flushing | Active comparator | Other: Aspiration without flushing follicles with culture media, Other: Follicular FlushingFlushing follicles with embryo culture media prior to aspiration. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Pts ages 18-45 undergoing IVF
- Pts with ≤ 4 follicles that are ≥ 12mm on day of HCG
Key exclusion criteria (1 listed)
- Pts undergoing natural cycles (i.e. those with intentionally low # of follicles)
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 |
|---|---|---|
| Aspiration without flushing follicles with culture mediaAspiration without flushing follicles with culture media. | Other | Follicular flushing |
| Follicular FlushingFlushing follicles with embryo culture media prior to aspiration. | Other | Follicular flushing |
Primary outcome
FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS
Time frame: 2 weeks
To evaluate the number of oocytes retrieved with follicular flushing in poor responders
8 secondary outcomes
FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS
Time frame: 2 weeks
FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS
Time frame: 2 weeks
FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS
Time frame: 2 weeks
FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS
Time frame: 2 weeks
FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS
Time frame: 2 weeks
FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS
Time frame: 2 weeks
FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS
Time frame: 2 weeks
FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS
Time frame: 2 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 14 Jan 2019.
- Derived from this study: PubMed 24014603Mok-Lin E, Brauer AA, Schattman G, Zaninovic N, Rosenwaks Z, Spandorfer S. Follicular flushing and in vitro fertilization outcomes in the poorest responders: a randomized controlled trial. Hum Reprod. 2013 Nov;28(11):2990-5. doi: 10.1093/humrep/det350. Epub 2013 Sep 5.
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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.
Steven D. Spandorfer, MD principal investigator
Weill Medical College of Cornell
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aspiration without flushing follicles with culture media and Follicular Flushing in people with Fertilization, run by Weill Medical College of Cornell University 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 2 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 14 Jan 2019. 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.
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?
FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01558141, which also lists 1 linked publication.
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 14 Jan 2019.