InfertilityAECCTNCT01472861
Autologous Endometrial Coculture (AECCT)
A study testing AECC (Autologous endometrial coculture) and no endometrial biopsy or Autologous endometrial coculture (AECC) performed in people with Infertility, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
The purpose of this study is to determine if the use of Autologous Endometrial Coculture (AECC) in young in vitro fertilization (IVF) patients with poor ovarian reserve improves pregnancy outcome. Read more about this study
- Who is it for?
- Ages 18 to 38 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- AECC (Autologous endometrial coculture) and no endometrial biopsy or Autologous endometrial coculture (AECC) performed
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Jun 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 18 to 38 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy women undergoing IVF at CRMI
- Age ≤ 38 years
- Poor ovarian reserve with antral follicle count less than 6 follicles, cycle day 2/3 FSH > 12 ng/ml, AMH < 0.5 ng/ml
Who cannot join
- Healthy women undergoing IVF with male factor, severe endometriosis, or tubal factor infertility
- Donor patients
- Contraindications for the use of gonadotropins (i.e. pregnancy, lactation, undiagnosed vaginal bleeding or ovarian cysts)
- Recent or current medical conditions where the patient is not medically stable to undergo stimulation or egg retrieval, HIV infection, diabetes, cardiovascular disease, gastrointestinal, hepatic disease, renal or pulmonary disease.
- Any patient who is not a candidate for IVF
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Reproducutve Medicine; Weill Cornell Medical College
New York, New York, 10021
About this study
Official title: A Randomized Controlled Trial Evaluating Autologous Endometrial Coculture (AECC) As An Effective Tool For Young Patients With Poor Ovarian Reserve
The purpose of this study is to determine if the use of Autologous Endometrial Coculture (AECC) in young in vitro fertilization (IVF) patients with poor ovarian reserve improves pregnancy outcome.
Read the detailed description
Young women with poor ovarian reserve are commonly given a poor prognosis for IVF success. Standard culture media for fertilizing oocytes (unfertilized eggs) is commonly used in IVF which closely resembles tubal fluid. Efforts to create optimal culture conditions for fertilization of human embryos for women with poor quality embryos and/or repeated implantation failures have been developed at our center by using AECC. AECC involves placing a patient's fertilized eggs on top of a layer of cells from her own uterine lining, creating a more natural environment for embryo development and maximizing the chance for IVF pregnancy. The investigators will prospectively randomize young patients (≤ age 38 years) poor ovarian reserve to AECC or no AECC with standard culture media to study pregnancy outcome.
- Conditions
- Infertility
- Being tested
- AECC (Autologous endometrial coculture), no endometrial biopsy or Autologous endometrial coculture (AECC) performed
- Keywords
- coculture, endometrial biopsy, IVF poor responders
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AECC (Autologous endometrial coculture)Procedure or surgery
endometrial biopsy with autologous endometrial coculture
no endometrial biopsy or Autologous endometrial coculture (AECC) performedOther
routine procedures with out biopsy
| Study group | Role | What they receive |
|---|---|---|
| No AECC | Placebo comparator | Routine procedures without AECC Receives: Other: no endometrial biopsy or Autologous endometrial coculture (AECC) performed |
| AECC | Experimental | Endometrial biopsy and Autologous endometrial coculture Receives: Procedure: AECC (Autologous endometrial coculture) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy outcome
Measured: 1 month
Secondary outcomes (1)
Embryo quality
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2011 (estimated)
- Study startOct 2009
- Primary completionJun 2014
- Study completionJun 2015
Why it stopped: poor recruitment
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Spandorfer Steven, MD, Principal investigator, Weill Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01472861
- Sponsor's protocol ID
- 0903010293
- Acronym
- AECCT
- Status last verified
- Jun 2015
- First submitted
- 11 Nov 2011
- Last updated
- 12 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Evaluating Autologous Endometrial Coculture (AECC) As An Effective Tool For Young Patients With Poor Ovarian Reserve
- ClinicalTrials.gov ID
- NCT01472861
- Acronym / sponsor ID
- AECCT / 0903010293
- Conditions
- Infertility
- Keywords
- coculture, endometrial biopsy, IVF poor responders
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: poor recruitment
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 17 Nov 2011 (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 of this study is to determine if the use of Autologous Endometrial Coculture (AECC) in young in vitro fertilization (IVF) patients with poor ovarian reserve improves pregnancy outcome.
Detailed description
Young women with poor ovarian reserve are commonly given a poor prognosis for IVF success. Standard culture media for fertilizing oocytes (unfertilized eggs) is commonly used in IVF which closely resembles tubal fluid. Efforts to create optimal culture conditions for fertilization of human embryos for women with poor quality embryos and/or repeated implantation failures have been developed at our center by using AECC. AECC involves placing a patient's fertilized eggs on top of a layer of cells from her own uterine lining, creating a more natural environment for embryo development and maximizing the chance for IVF pregnancy. The investigators will prospectively randomize young patients (≤ age 38 years) poor ovarian reserve to AECC or no AECC with standard culture media to study pregnancy outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No AECC | Placebo comparator | Other: no endometrial biopsy or Autologous endometrial coculture (AECC) performedRoutine procedures without AECC |
| AECC | Experimental | Procedure: AECC (Autologous endometrial coculture)Endometrial biopsy and Autologous endometrial coculture |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy women undergoing IVF at CRMI
- Age ≤ 38 years
- Poor ovarian reserve with antral follicle count less than 6 follicles, cycle day 2/3 FSH > 12 ng/ml, AMH < 0.5 ng/ml
Key exclusion criteria (5 listed)
- Healthy women undergoing IVF with male factor, severe endometriosis, or tubal factor infertility
- Donor patients
- Contraindications for the use of gonadotropins (i.e. pregnancy, lactation, undiagnosed vaginal bleeding or ovarian cysts)
- Recent or current medical conditions where the patient is not medically stable to undergo stimulation or egg retrieval, HIV infection, diabetes, cardiovascular disease, gastrointestinal, hepatic disease, renal or pulmonary disease.
- Any patient who is not a candidate for IVF
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 |
|---|---|---|
| AECC (Autologous endometrial coculture)endometrial biopsy with autologous endometrial coculture | Procedure or surgery | AECC |
| no endometrial biopsy or Autologous endometrial coculture (AECC) performedroutine procedures with out biopsy | Other | No AECC |
Primary outcome
Pregnancy outcome
Time frame: 1 month
1 secondary outcome
Embryo quality
Time frame: 1 month
Results and safety
The study was stopped early (reason given: poor recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2015.
- Ronald O. Perelman and Claudia Cohen Center for Reproductive MedicineLink provided by the sponsor.
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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.
Spandorfer Steven, MD principal investigator
Weill Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AECC (Autologous endometrial coculture) and no endometrial biopsy or Autologous endometrial coculture (AECC) performed in people with Infertility, 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 3 inclusion and 5 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 12 Jun 2015. 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. Some participants in this study may receive a placebo. 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 stopped early (reason given: poor recruitment). 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 outcome (time frame: 1 month). 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 12 Jun 2015.