Infertility, FemaleNCT01083745
Assessment of Blood and Follicular Fluid Immune Cell Constitution in Patients Undergoing in Vitro Fertilization
An observational study of Infertility, Female, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
The etiology of infertility in the majority of patients with poor response to ovarian stimulation remains unknown. This study will investigate the role of immune cells (T cells, B cells, dendritic cells and NK cells), that constitute the immune system which normally fights infection and cancer. Read more about this study
- Who is it for?
- Ages 27 to 43 years, women only
- Conditions the study is for
- Infertility, Female
- How many people
- Not given
- Where
- 1 siteIsrael
- Study dates
- Start not givento not given
- 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 27 to 43 years
- Women only
- No healthy volunteers
- Adult
Study population: IVF clinic patients in tertiary care center
Who may be able to join
- Age 27-43 years
- Diagnosis of infertility due to endometriosis, severe male factor, tubal occlusion.
- Patient undergoing IVF
Who cannot join
- Body mass index (BMI) > 38 kg/m2
- Abnormal uterine cavity as evidenced by sonohysterogram or hysterosalpingography
- Any current use of systemic steroid medication or any infertility treatment within 3 months of study enrollment.
- Any contraindication to being pregnant and carrying a pregnancy to term.
- Any ovarian or abdominal abnormality that may interfere with adequate TVS evaluation.
- Absence of one or two ovaries
Show all 15Show fewer
- Clinically relevant systemic disease (e.g., Insulin-dependent diabetes, adrenal dysfunction, organic intracranial lesion, polycystic ovarian syndrome, hyperprolactinemia, or hypothalamic tumor) or serious illness (Neoplasia).
- History (within past 12 months) or current abuse of alcohol or drugs.
- Administration of any investigational drugs within three months prior to study enrollment.
- Any medical condition that may interfere with the absorption, distribution, metabolism or excretion of the study drugs, gastrointestinal diseases, mal absorption syndromes and liver dysfunction
- Unexplained gynecological bleeding.
- Ejaculated sperm is not sufficient for ICSI
- Patient not able to communicate adequately with the investigators and to comply with the requirements of the entire study.
- Abnormal COH screening blood done for both partners, including: prolactin, thyroid stimulating hormone, HIV serology, Hepatitis B and C serology, Rubella, group and screen and syphilis serology prior to participation in study.
- Unwillingness to give written informed consent. Previous entry into this study or simultaneous participation in another clinical trial.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Hillel Yaffe Medical Center
Hadera, 38100
Ofer Fainaru, MD, 972-4-6304750, ofer.fainaru@hy.health.gov.il
Adrian Ellenbogen, MD
About this study
The etiology of infertility in the majority of patients with poor response to ovarian stimulation remains unknown. This study will investigate the role of immune cells (T cells, B cells, dendritic cells and NK cells), that constitute the immune system which normally fights infection and cancer. We, the investigators, have found that specialized NK cells that help with new blood vessel formation, are found in the fluid surrounding the egg during IVF, only in patients with good response to ovarian stimulation. We now wish to expand our studies and correlate our findings to ovarian blood flow , as measured by 3D ultrasound and to the presence of other cells in the immune system.
- Conditions
- Infertility, Female
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| IVF patients - 1 | Poor responders | |
| IVF patients - 2 | Good responders |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, FemaleStudies 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
- Observational model
- Cohort
- Time perspective
- Prospective
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01083745
- Sponsor's protocol ID
- 022-10
- Status last verified
- Mar 2010
- First submitted
- 8 Mar 2010
- Last updated
- 18 Mar 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Blood and Follicular Fluid Immune Cell Constitution in Patients Undergoing in Vitro Fertilization
- ClinicalTrials.gov ID
- NCT01083745
- Acronym / sponsor ID
- 022-10
- Conditions
- Infertility, Female
- Study type
- Observational
- Recruitment status
- Unknown status
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- First posted
- 10 Mar 2010 (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 etiology of infertility in the majority of patients with poor response to ovarian stimulation remains unknown. This study will investigate the role of immune cells (T cells, B cells, dendritic cells and NK cells), that constitute the immune system which normally fights infection and cancer. We, the investigators, have found that specialized NK cells that help with new blood vessel formation, are found in the fluid surrounding the egg during IVF, only in patients with good response to ovarian stimulation. We now wish to expand our studies and correlate our findings to ovarian blood flow , as measured by 3D ultrasound and to the presence of other cells in the immune system.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IVF patients - 1 | – | –Poor responders |
| IVF patients - 2 | – | –Good responders |
Who may qualify
- Ages
- 27 to 43 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- IVF clinic patients in tertiary care center
Key inclusion criteria (3 listed)
- Age 27-43 years
- Diagnosis of infertility due to endometriosis, severe male factor, tubal occlusion.
- Patient undergoing IVF
Key exclusion criteria (15 listed)
- Body mass index (BMI) > 38 kg/m2
- Abnormal uterine cavity as evidenced by sonohysterogram or hysterosalpingography
- Any current use of systemic steroid medication or any infertility treatment within 3 months of study enrollment.
- Any contraindication to being pregnant and carrying a pregnancy to term.
- Any ovarian or abdominal abnormality that may interfere with adequate TVS evaluation.
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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2010.
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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.
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, Female, run by Hillel Yaffe 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 3 inclusion and 15 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 18 Mar 2010. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
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 18 Mar 2010.