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

Infertility, Female Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01083745
• Other study ID #: 022-10
• Status: Not yet recruiting
• Phase: N/A
• First received: March 8, 2010
• Last updated: March 16, 2010

Study information

• Verified date: March 2010
• Source: Hillel Yaffe Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 27 Years to 43 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Infertility, Female

Locations

Country	Name	City	State
Israel	Hillel Yaffe Medical Center	Hadera

Sponsors (1)

Lead Sponsor	Collaborator
Hillel Yaffe Medical Center

Country where clinical trial is conducted

Israel,