CClinicalTrials.gg
Status unknownNCT02342106Updated Jan 19, 2015

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

An observational study in Infertility, sponsored by Hillel Yaffe Medical Center. Status unknown at 1 site in Israel. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2015-01-19.

Sponsored by Hillel Yaffe Medical Center · Observational

The sponsor has not verified this record recently (last verified Jan 2015), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
100
Ages
18 Years to 45 Years
Sex
Female
01

Study 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.

Read the detailed description

The study will be an observational study using discarded material from patients undergoing IVF treatment. On the day of ovum pick up, the fluid aspirated from the first follicle in each ovary will be saved and analyzed for cellular content by fluorescence-activated cell sorter (FACS) analysis and cytokine and hormone by Enzyme-linked immunosorbent assay (ELISA) and quantitative polymerase chain reaction (qPCR). In addition, a total of 5cc of blood will be drawn from the patient when introducing the intravenous line for analysis of immune cell composition,hormones and cytokine levels. During the whole study number of oocytes retrieved,number of mature oocytes,number of fertilizations,implantation rates and clinical pregnancy rates will be documented as well.

02

Conditions studied

  • Infertility

Browse trials for

03

In context

Infertility

2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.

This study's planned enrollment of 100 is below the median of 200 across 714 observational studies indexed under Infertility.

Browse Infertility studies →

Lead sponsor

Hillel Yaffe Medical Center is the lead sponsor of 301 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Women undergoing IVF treatment.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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.

06

What researchers measure

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.

    Time frame: 36 hours after hCG injection

07

Study locations

1 site
  • Department of Obstetrics and Gynecology, Hillel-Yaffe Medical Center
    Hadera, 38100, Israel
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 19, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02342106
Lead sponsor
Hillel Yaffe Medical Center
Responsible party
Sponsor
First posted
Jan 19, 2015
Start date
Jan 2015
Primary completion
Aug 2016 (estimated)
Completion
Feb 2017 (estimated)
Last update
Jan 19, 2015

Study contacts

Ofer Limonad, MD
Contact
oferlimonad@gmail.com
+972 52 5322972
Ofer Limonad, MD
Contact
+972 4 6304248
Ofer Limonad, MD
principal investigator · Hillel Yaffe Medical Center Hadera Israel

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion