Assessment of Blood and Follicular Fluid Immune Cell Constitution in Patients Undergoing in Vitro Fertilization

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01083745
Recruitment Status : Unknown
Verified March 2010 by Hillel Yaffe Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : March 10, 2010
Last Update Posted : March 18, 2010
Information provided by:
Hillel Yaffe Medical Center

Brief 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. 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.

Condition or disease
Infertility, Female

Study Type : Observational
Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by the National Library of Medicine

IVF patients - 1
Poor responders
IVF patients - 2
Good responders

Information from the National Library of Medicine

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Ages Eligible for Study:   27 Years to 43 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
IVF clinic patients in tertiary care center

Inclusion Criteria:

  • Age 27-43 years
  • Diagnosis of infertility due to endometriosis, severe male factor, tubal occlusion.
  • Patient undergoing IVF

Exclusion Criteria:

  • 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
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01083745

Hillel Yaffe Medical Center Not yet recruiting
Hadera, Israel, 38100
Contact: Ofer Fainaru, MD    972-4-6304750   
Sub-Investigator: Adrian Ellenbogen, MD         
Sponsors and Collaborators
Hillel Yaffe Medical Center

Responsible Party: Dr. Adrian Ellenbogen, Hillel Yaffe Medical Center, IVF Unit Identifier: NCT01083745     History of Changes
Other Study ID Numbers: 022-10
First Posted: March 10, 2010    Key Record Dates
Last Update Posted: March 18, 2010
Last Verified: March 2010

Additional relevant MeSH terms:
Infertility, Female
Genital Diseases, Male
Genital Diseases, Female