Assessment of Myeloid Cell Constitution in the Follicular Fluid of Women Undergoing In-vitro Fertilization

NCT02342106 | Unknown

• 1 other identifier: 0054-14-HYMC
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators will study the immune cell subpopulations in follicular fluid of patients undergoing In-Vitro Fertilization (IVF) treatment in our clinic. The investigators will corelate the presence of immature myeloid cells to the ovarian stimulation response as indicated by follicle stimulating hormone (FSH) and number of follicles or estradiol level developed on the day of human chorionic gonadotropin (hCG) administration.

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

• Amount of immature myeloid cells accumulate in the ovarian follicular fluid as measure of correlation with ovarian response to gonadotropins.

  After oocyte retrieval, the fluid of the largest follicle in each ovary will be collected. Follicular fluid cells will be isolated and immunostained for flow cytometry using monoclonal antibodies and the amount of immature myeloid cell will be assessed.

  36 hours after hCG injection

Study Arms (2)

Poor responders

In order to define the poor response in IVF, at least two of the following three features must be present: (i) advanced maternal age or any other risk factor for poor ovarian response; (ii) a previous poor ovarian response; and (iii) an abnormal ovarian reserve test . Two episodes of poor ovarian response after maximal stimulation are sufficient to define a patient as poor responder in the absence of advanced maternal age or abnormal ovarian reserve test. By definition, the term poor ovarian response refers to the ovarian response, and therefore, one stimulated cycle is considered essential for the diagnosis .

Good responders

Total number of antral follicles : 22-35 Normal (good) antral count, should have an excellent response to ovarian stimulation.Likely to respond well to low doses of FSH drugs. Very low risk for IVF cycle cancellation. Some risk for ovarian overstimulation if a Lupron trigger is not used for final egg maturation injection. Excellent pregnancy success rates.

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women undergoing IVF treatment.

You may qualify if:

• Women undergoing IVF treatment
• Infertility caused by one of the following : endometriosis, severe male factor, tubal occlusion, or unexplained.

You may not qualify if:

• An early follicular phase (day 2-4) FSH level \> 20 mIU/mL
• Abnormal uterine cavity
• Any contraindication for pregnancy
• Systemic disease
• History of alcohol or drug abuse

Sponsors & Collaborators

• Hillel Yaffe Medical Center: lead

Study Sites (1)

Department of Obstetrics and Gynecology, Hillel-Yaffe Medical Center

Hadera, 38100, Israel

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Follicular fluid

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Ofer Limonad, MD

  Hillel Yaffe Medical Center Hadera Israel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ofer Limonad, MD

CONTACT

+972 52 5322972; oferlimonad@gmail.com

Ofer Limonad, MD

CONTACT

+972 4 6304248

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2014
• First Posted: January 19, 2015
• Study Start: January 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: February 1, 2017
• Last Updated: January 19, 2015

Record last verified: 2015-01

Locations

IL (1)