Ovary InflammationNCT02999555
Novel Evaluation of Aspirated Follicular Fluid
A study testing Ovum pickup in people with Ovary Inflammation, run by Meir Medical Center at 1 site in Israel.
Trial summary
A molecular study of follicular fluid aspirated from ovarian follicles during routine in vitro fertilization treatment, after the eggs were identified and separated. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Ovary Inflammation
- What is being tested?
- Ovum pickup
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Feb 2017to Dec 2018
- 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
- All women going through a fertility/ fertility preservation indicated egg retrieval in the in vitro fertilization (IVF) unit in 'Meir medical center',
- Patients' informed consent
Who cannot join
- Patients refusing to take part in the study
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Meir Medical Center
Kfar Saba
Anat Hershko Klement, MD, 972549170084, anat.klement@gmail.com
About this study
Official title: Presence and Quantification of Inflammatory Cytokines, Dendritic Cells, Vasorin and Soluble Flt1 in Aspirated Follicular Fluid
A molecular study of follicular fluid aspirated from ovarian follicles during routine in vitro fertilization treatment, after the eggs were identified and separated.
Read the detailed description
Ovarian stimulation is a routine part of in vitro fertilization treatment: this process involves an inflammatory response in the developing follicles. We still do not completely understand the complex interactions leading to the maturation of the egg and the multiple interactions of the egg with its supporting cells. In this study we will assess follicular fluid, letf over after the eggs were identified and separated, for the presence of inflammatory mediators, dendritic cells , vasorin and soluble Flt1. The presence and quantification of these factors, as well as their correlation with the size of the aspirated follicle is the focus of this study.
- Conditions
- Ovary Inflammation
- Being tested
- Ovum pickup
- Medical subject headings
- Oophoritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ovum pickupProcedure or surgery
Also called Egg retrieval
Ovum pickup or Egg retrieval, that is performed not for the purpose of the study, but for the purpose of well known in vitro fertilization indications
| Study group | Role | What they receive |
|---|---|---|
| Aspirated follicular fluid | Experimental | Follicular fluid aspirated by follicle size and tested for the novel markers after eggs were identified and separated for the purpose of fertilization Receives: Procedure: Ovum pickup |
What is being measured
The primary outcome is the main question the study is designed to answer.
Soluble Vasorin levels
Measured: 24 hours post egg retrieval
Soluble Flt 1 levels
Measured: 24 hours post egg retrieval
Dendritic cells quantification
Measured: 24 hours post egg retrieval
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2016 (estimated)
- Study start1 Feb 2017
- Primary completionDec 2017 (estimated)
- Study completionDec 2018 (estimated)
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 Ovary InflammationStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Weizmann Institute of Science
- Responsible party
- Principal investigator, Anat Hershko Klement, Meir Medical Center
- Investigators
- MEIR medical center REB committee REB committee, Study chair, Tel Aviv University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02999555
- Sponsor's protocol ID
- MMC160192-16CTIL
- Status last verified
- Aug 2017
- First submitted
- 18 Dec 2016
- Last updated
- 11 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wulff C, Wiegand SJ, Saunders PT, Scobie GA, Fraser HM. Angiogenesis during follicular development in the primate and its inhibition by treatment with truncated Flt-1-Fc (vascular endothelial growth factor Trap(A40)). Endocrinology. 2001 Jul;142(7):3244-54. doi: 10.1210/endo.142.7.8258.
PubMed 11416048Gruemmer R, Motejlek K, Berghaus D, Weich HA, Neulen J. Regulation of soluble vascular endothelial growth factor receptor (sFlt-1/sVEGFR-1) expression and release in endothelial cells by human follicular fluid and granulosa cells. Reprod Biol Endocrinol. 2005 Oct 25;3:57. doi: 10.1186/1477-7827-3-57.
PubMed 16248895
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Presence and Quantification of Inflammatory Cytokines, Dendritic Cells, Vasorin and Soluble Flt1 in Aspirated Follicular Fluid
- ClinicalTrials.gov ID
- NCT02999555
- Acronym / sponsor ID
- MMC160192-16CTIL
- Conditions
- Ovary Inflammation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Collaborators
- Weizmann Institute of Science
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 21 Dec 2016 (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.
A molecular study of follicular fluid aspirated from ovarian follicles during routine in vitro fertilization treatment, after the eggs were identified and separated.
Detailed description
Ovarian stimulation is a routine part of in vitro fertilization treatment: this process involves an inflammatory response in the developing follicles. We still do not completely understand the complex interactions leading to the maturation of the egg and the multiple interactions of the egg with its supporting cells. In this study we will assess follicular fluid, letf over after the eggs were identified and separated, for the presence of inflammatory mediators, dendritic cells , vasorin and soluble Flt1. The presence and quantification of these factors, as well as their correlation with the size of the aspirated follicle is the focus of this study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aspirated follicular fluid | Experimental | Procedure: Ovum pickupFollicular fluid aspirated by follicle size and tested for the novel markers after eggs were identified and separated for the purpose of fertilization |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- All women going through a fertility/ fertility preservation indicated egg retrieval in the in vitro fertilization (IVF) unit in 'Meir medical center',
- Patients' informed consent
Key exclusion criteria (1 listed)
- Patients refusing to take part in the study
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 |
|---|---|---|
| Ovum pickupAlso: Egg retrievalOvum pickup or Egg retrieval, that is performed not for the purpose of the study, but for the purpose of well known in vitro fertilization indications | Procedure or surgery | Aspirated follicular fluid |
Primary outcome
Soluble Vasorin levels
Time frame: 24 hours post egg retrieval
Soluble Flt 1 levels
Time frame: 24 hours post egg retrieval
Dendritic cells quantification
Time frame: 24 hours post egg retrieval
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2017.
- Background: PubMed 11416048Wulff C, Wiegand SJ, Saunders PT, Scobie GA, Fraser HM. Angiogenesis during follicular development in the primate and its inhibition by treatment with truncated Flt-1-Fc (vascular endothelial growth factor Trap(A40)). Endocrinology. 2001 Jul;142(7):3244-54. doi: 10.1210/endo.142.7.8258.
- Background: PubMed 16248895Gruemmer R, Motejlek K, Berghaus D, Weich HA, Neulen J. Regulation of soluble vascular endothelial growth factor receptor (sFlt-1/sVEGFR-1) expression and release in endothelial cells by human follicular fluid and granulosa cells. Reprod Biol Endocrinol. 2005 Oct 25;3:57. doi: 10.1186/1477-7827-3-57.
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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.
MEIR medical center REB committee REB committee study chair
Tel Aviv University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ovum pickup in people with Ovary Inflammation, run by Meir Medical Center at 1 site in Israel.
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: status not confirmed, as of the sponsor's last update on 11 Aug 2017. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anat Hershko Klement, MD (972549170084, anat.klement@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Soluble Vasorin levels (time frame: 24 hours post egg retrieval). The study lists 3 primary outcomes in all. 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 NCT02999555, 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 11 Aug 2017.