InfertilityNCT00264992
Implantation and Cytokine Expression
An observational study of Infertility, run by UMC Utrecht at 1 site in Netherlands.
Trial summary
Implantation failure of the embryo might be the result from the environment in the uterus. Proteins (cytokines) are screted by the endometrium which can result in a pro or anti inflammatory environment. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Infertility
- How many people
- 160 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2006to Nov 2007
- Phase
- Observational
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- all women starting their first or second IVF/ ICSI treatment cycle.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
University Medical center Utrecht
Utrecht, Utrecht, 3584 CX
About this study
Official title: The Cytokine Paired Footprint of Successful Implantation
Implantation failure of the embryo might be the result from the environment in the uterus. Proteins (cytokines) are screted by the endometrium which can result in a pro or anti inflammatory environment. The aim of this study is to identify pre-implantation endometrial and embryo cytokine expression profiles associated with successful and unsuccessful embryo implantation in assisted reproduction cycles.
Read the detailed description
Rationale:
Failure of the transferred embryo to implant remains the most important limiting factor determining IVF success rates. It is hypothesed that implantation failure following IVF treatment may be caused by abnormal cytokine expression by embryos and endometrium and by subclinical bacterial vaginosis. Analysis of cytokine expression in the culture media of embryos and in the endometrium during 'the window of implantation' offers the opportunity to study the cross-talk between the embryo and endometrium and identify optimal cytokine expression patterns. Increased knowledge of cytokine interaction and the impact of bacterial vaginosis on cytokine expression may serve as the basis from which to develop and apply treatment regimens to improve embryo selection and endometrial preparation.
Objective:
The aim of this study is to identify pre-implantation endometrial and embryo cytokine expression profiles associated with successful and unsuccessful implantation.
Study design:
The study design is a prospective, mono-center, observational cohort study. Study population: We will aim to include at least 160 women initiating their first or second IVF/ ICSI cycle. A subgroup of forty women will be invited for endometrial secretion aspiration in a natural cycle as well.
Main study parameters/endpoints:
For research purposes, transcervical aspiration of endometrial secretion will be performed. An endocervical swab will be taken to assess the existence of bacterial vaginosis. A single ultrasound measurement of uterine artery pulsatile resistance will be made (by pulsed Doppler) and endometrium thickness will be measured. The embryo transfer and IVF/ ICSI treatment will be performed as usual. The main study parameter is the cytokine profile in the endometrium and from the embryo culture medium, measured with Luminex (a multiplex immunoassay). Implantation rate, ultrasound measurements and bacterial vaginosis will be correlated to the cytokine profile. The cytokine profile from the endometrium will be compared with the cytokine profile from the supernatant of the embryo. In a reference group the cytokine profile in the endometrial secretion in a natural cycle will be compared to the cytokine profile in a IVF/ ICSI treatment cycle.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
The theoretical risk associated with this study might be disruption of embryo implantation. However, our group has developed a technique of obtaining endometrial material at the time of embryo transfer which, as we have previously shown, does not disrupt the process of implantation. The burden is minimal; patients will not have to make an extra visit to the hospital. The investigations are painless and will not take more than a few minutes. No side effects or risks have been reported.
- Conditions
- Infertility
- Keywords
- embryo implantation, in vitro fertilization,, cytokine expression
- Medical subject headings
- Infertility
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2005 (estimated)
- Study startJan 2006
- Primary completionNov 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 160 participants
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Investigators
- Nick Macklon, Prof. dr., Principal investigator, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00264992
- Sponsor's protocol ID
- ICE-STUDY
- Status last verified
- May 2008
- First submitted
- 9 Dec 2005
- Last updated
- 29 May 2008
- Results posted
- No
Publications
van der Gaast MH, Beier-Hellwig K, Fauser BC, Beier HM, Macklon NS. Endometrial secretion aspiration prior to embryo transfer does not reduce implantation rates. Reprod Biomed Online. 2003 Jul-Aug;7(1):105-9. doi: 10.1016/s1472-6483(10)61737-3.
PubMed 12930588Boomsma CM, Kavelaars A, Eijkemans MJ, Lentjes EG, Fauser BC, Heijnen CJ, Macklon NS. Endometrial secretion analysis identifies a cytokine profile predictive of pregnancy in IVF. Hum Reprod. 2009 Jun;24(6):1427-35. doi: 10.1093/humrep/dep011. Epub 2009 Feb 19.
PubMed 19228761
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Cytokine Paired Footprint of Successful Implantation
- ClinicalTrials.gov ID
- NCT00264992
- Acronym / sponsor ID
- ICE-STUDY
- Conditions
- Infertility
- Keywords
- embryo implantation, in vitro fertilization,, cytokine expression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 13 Dec 2005 (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.
Implantation failure of the embryo might be the result from the environment in the uterus. Proteins (cytokines) are screted by the endometrium which can result in a pro or anti inflammatory environment. The aim of this study is to identify pre-implantation endometrial and embryo cytokine expression profiles associated with successful and unsuccessful embryo implantation in assisted reproduction cycles.
Detailed description
Rationale:
Failure of the transferred embryo to implant remains the most important limiting factor determining IVF success rates. It is hypothesed that implantation failure following IVF treatment may be caused by abnormal cytokine expression by embryos and endometrium and by subclinical bacterial vaginosis. Analysis of cytokine expression in the culture media of embryos and in the endometrium during 'the window of implantation' offers the opportunity to study the cross-talk between the embryo and endometrium and identify optimal cytokine expression patterns. Increased knowledge of cytokine interaction and the impact of bacterial vaginosis on cytokine expression may serve as the basis from which to develop and apply treatment regimens to improve embryo selection and endometrial preparation.
Objective:
The aim of this study is to identify pre-implantation endometrial and embryo cytokine expression profiles associated with successful and unsuccessful implantation.
Study design:
The study design is a prospective, mono-center, observational cohort study. Study population: We will aim to include at least 160 women initiating their first or second IVF/ ICSI cycle. A subgroup of forty women will be invited for endometrial secretion aspiration in a natural cycle as well.
Main study parameters/endpoints:
For research purposes, transcervical aspiration of endometrial secretion will be performed. An endocervical swab will be taken to assess the existence of bacterial vaginosis. A single ultrasound measurement of uterine artery pulsatile resistance will be made (by pulsed Doppler) and endometrium thickness will be measured. The embryo transfer and IVF/ ICSI treatment will be performed as usual. The main study parameter is the cytokine profile in the endometrium and from the embryo culture medium, measured with Luminex (a multiplex immunoassay). Implantation rate, ultrasound measurements and bacterial vaginosis will be correlated to the cytokine profile. The cytokine profile from the endometrium will be compared with the cytokine profile from the supernatant of the embryo. In a reference group the cytokine profile in the endometrial secretion in a natural cycle will be compared to the cytokine profile in a IVF/ ICSI treatment cycle.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
The theoretical risk associated with this study might be disruption of embryo implantation. However, our group has developed a technique of obtaining endometrial material at the time of embryo transfer which, as we have previously shown, does not disrupt the process of implantation. The burden is minimal; patients will not have to make an extra visit to the hospital. The investigations are painless and will not take more than a few minutes. No side effects or risks have been reported.
Study design
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- all women starting their first or second IVF/ ICSI treatment cycle.
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.
Primary outcome
Not reported in the source record.
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 29 May 2008.
- Background: PubMed 12930588van der Gaast MH, Beier-Hellwig K, Fauser BC, Beier HM, Macklon NS. Endometrial secretion aspiration prior to embryo transfer does not reduce implantation rates. Reprod Biomed Online. 2003 Jul-Aug;7(1):105-9. doi: 10.1016/s1472-6483(10)61737-3.
- Derived from this study: PubMed 19228761Boomsma CM, Kavelaars A, Eijkemans MJ, Lentjes EG, Fauser BC, Heijnen CJ, Macklon NS. Endometrial secretion analysis identifies a cytokine profile predictive of pregnancy in IVF. Hum Reprod. 2009 Jun;24(6):1427-35. doi: 10.1093/humrep/dep011. Epub 2009 Feb 19.
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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.
Nick Macklon, Prof. dr. principal investigator
UMC Utrecht
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, run by UMC Utrecht at 1 site in Netherlands.
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 29 May 2008. 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 Netherlands. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00264992, which also lists 2 linked publications.
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 29 May 2008.