InfertilityNCT02341339
Utility of Fallopian Tube Cocultures in Assisted Reproductive Technology
A study testing Laparoscopic Surgery (Biopsies of fallopian tube lumen) using a laparoscopic brush/biopsy device in people with Infertility, run by Weill Medical College of Cornell University.
Trial summary
Prospective Feasibility Study: Fallopian tube cells will be obtained from patients undergoing laparoscopic surgery during their surgical evaluation of infertility. Of note, these patients are already scheduled to undergo surgery as part of their standard of care. Read more about this study
- Who is it for?
- Ages 25 to 40 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Laparoscopic Surgery (Biopsies of fallopian tube lumen) using a laparoscopic brush/biopsy device
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento Aug 2015
- 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 25 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women undergoing assisted reproductive technology at Weill Cornell Medical College (WCMC) and are scheduled to undergo surgery as part of their standard of care
- Women who had a prior failed IVF cycle
- Women with normal Hysterosalpingogram (HSG) or a prior laparoscopy confirming normal tubal status
- Both the patient (potential subject) and her partner must sign the consent form
Who cannot join
- Pregnancy
- Undiagnosed vaginal bleeding
- Fallopian tube disease
About this study
Prospective Feasibility Study:
Fallopian tube cells will be obtained from patients undergoing laparoscopic surgery during their surgical evaluation of infertility. Of note, these patients are already scheduled to undergo surgery as part of their standard of care.
Read the detailed description
The surgical technique will involve laparoscopic brush and tissue biopsies of the fallopian tube lumen. A small piece of the fallopian tube lining will be removed during the surgery.The biopsy is a minimally invasive and relatively pain free procedure. Co culture blood serum will be drawn at least one day prior to the biopsy and during the IVF cycle. The fallopian tube sample is sent to the Center for Reproductive Medicine (CRM) lab where it is treated, purified and frozen. The next month or whenever the physician deems appropriate, the patient will then undergo a typical IVF cycle and will be given standard medication protocol determined by her physician to stimulate egg growth in her ovaries. The patient's eggs will be retrieved and mixed with sperm. At this time, the lab will begin to thaw and grow the fallopian tube cells. Once fertilization is confirmed, the patient's embryos will be placed on top of her own (now thawed) fallopian tube cells and allowed to grow. Subsequently, the embryos will be placed on top of her uterus for implantation and pregnancy.
- Conditions
- Infertility
- Being tested
- Laparoscopic Surgery (Biopsies of fallopian tube lumen) using a laparoscopic brush/biopsy device
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic Surgery (Biopsies of fallopian tube lumen) using a laparoscopic brush/biopsy deviceProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Fallopian Tube Co-culture | Experimental | fallopian tube biopsy for co-culture of embryos Receives: Procedure: Laparoscopic Surgery (Biopsies of fallopian tube lumen) using a laparoscopic brush/biopsy device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with good embryo quality as a measure of efficacy
The outcomes measures for embryo quality will include an assessment of the embryo grade, embryo fragmentation rates, implantation rates and pregnancy rates.
Measured: 8 weeks
Secondary outcomes (1)
Number of participants with Adverse Events as a measure of Safety and Tolerability
We will assess the incidence of pain, bleeding and infection rates
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2015 (estimated)
- Primary completionAug 2015
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 Weill Medical College of Cornell 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rony Elias, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02341339
- Sponsor's protocol ID
- WeillMC
- Status last verified
- Aug 2015
- First submitted
- 27 Oct 2014
- Last updated
- 11 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of Fallopian Tube Cocultures in Assisted Reproductive Technology
- ClinicalTrials.gov ID
- NCT02341339
- Acronym / sponsor ID
- WeillMC
- Conditions
- Infertility
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Primary completion
- Aug 2015 (actual)
- First posted
- 19 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.
Prospective Feasibility Study:
Fallopian tube cells will be obtained from patients undergoing laparoscopic surgery during their surgical evaluation of infertility. Of note, these patients are already scheduled to undergo surgery as part of their standard of care.
Detailed description
The surgical technique will involve laparoscopic brush and tissue biopsies of the fallopian tube lumen. A small piece of the fallopian tube lining will be removed during the surgery.The biopsy is a minimally invasive and relatively pain free procedure. Co culture blood serum will be drawn at least one day prior to the biopsy and during the IVF cycle. The fallopian tube sample is sent to the Center for Reproductive Medicine (CRM) lab where it is treated, purified and frozen. The next month or whenever the physician deems appropriate, the patient will then undergo a typical IVF cycle and will be given standard medication protocol determined by her physician to stimulate egg growth in her ovaries. The patient's eggs will be retrieved and mixed with sperm. At this time, the lab will begin to thaw and grow the fallopian tube cells. Once fertilization is confirmed, the patient's embryos will be placed on top of her own (now thawed) fallopian tube cells and allowed to grow. Subsequently, the embryos will be placed on top of her uterus for implantation and pregnancy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fallopian Tube Co-culture | Experimental | Procedure: Laparoscopic Surgery (Biopsies of fallopian tube lumen) using a laparoscopic brush/biopsy devicefallopian tube biopsy for co-culture of embryos |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women undergoing assisted reproductive technology at Weill Cornell Medical College (WCMC) and are scheduled to undergo surgery as part of their standard of care
- Women who had a prior failed IVF cycle
- Women with normal Hysterosalpingogram (HSG) or a prior laparoscopy confirming normal tubal status
- Both the patient (potential subject) and her partner must sign the consent form
Key exclusion criteria (3 listed)
- Pregnancy
- Undiagnosed vaginal bleeding
- Fallopian tube disease
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 |
|---|---|---|
| Laparoscopic Surgery (Biopsies of fallopian tube lumen) using a laparoscopic brush/biopsy device | Procedure or surgery | Fallopian Tube Co-culture |
Primary outcome
Number of participants with good embryo quality as a measure of efficacy
Time frame: 8 weeks
The outcomes measures for embryo quality will include an assessment of the embryo grade, embryo fragmentation rates, implantation rates and pregnancy rates.
1 secondary outcome
Number of participants with Adverse Events as a measure of Safety and Tolerability
Time frame: 8 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2015.
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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.
Rony Elias, MD principal investigator
Weill Medical College of Cornell University
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic Surgery (Biopsies of fallopian tube lumen) using a laparoscopic brush/biopsy device in people with Infertility, run by Weill Medical College of Cornell University.
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 3 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: withdrawn, as of the sponsor's last update on 11 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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 participants with good embryo quality as a measure of efficacy (time frame: 8 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 11 Aug 2015.