Clinical Research Details

Descriptive Information
Association between concentrations of non-essential heavy metals and organic toxicants in the follicular fluid of infertile women and the outcome of IVF/ICSI treatment

Johnny Awwad
jawwad@aub.edu.lb

BIO-2017-0535
Recruiting

Observational  

Phase 0  

No
Coordinators
Layal Hamdar
lh72@aub.edu.lb
Extension: 5606
Conditions and Keywords
Infertility
heavy metals,follicular fluid,IVF/ICSI
Study Design
Other: Describe in Detailed Description
N/A: Not Applicable
Observational Study
N/A: Not Applicable
N/A: Not Applicable
N/A: Not Applicable
N/A: Not Applicable
Eligibility and IRB
Female
Min: 18
Max: 42
Yes
Yes

Human exposure to environmental pollutants is widespread. Evidence suggests that exposure to non-essential heavy metals and organic toxicants may adversely affect gamete function and threaten human reproductive health. Lead (Pb), cadmium (Cd), arsenic (As), barium (Ba), mercury (Hg) and uranium (U) are non-essential xenobiotics that have been detected in most of the general population. Polychlorinated biphenyls (PCBs), Phthalates, Parabens and Bisphenol A (BPA) used in the industry, have been implicated in fertility disruption through various mechanism. These toxicants have also been detected in human follicular fluid. Their effect on fertility in women undergoing In-Vitro fertilization remains a subject of debate.

Lebanon has been the scene of several wars over the past 30 years, which led to several demolition and reconstruction cycles, and unchecked exposure to numerous grades of war ammunitions. In the absence of a strong central government, the country has also suffered a quasi-absence of control on industrial byproducts and waste material. As a consequence, heavy metals and organic pollutants have likely been released in the environment, contaminating various aspects of human life. Indeed, these elements have been detected in food, air, soil, as well as human tissues. Our previous study investigated the concentrations of heavy metals in the blood and semen of Lebanese infertile men and correlated these findings with semen quality measures.

This is a prospective non-interventional study which will determine the concentrations of non-essential heavy metals and organic toxicants in the follicular fluid of 100 women undergoing IVF/ICSI treatment at the American University of Beirut Medical Center (AUBMC) Fertility Center. Follicular fluid, which otherwise is a discarded product following oocyte collection, will be saved for research. Measurements of these toxic elements will be correlated with fertility outcome measures including live births, fertilization, embryo development and implantation. Although In-Vitro Fertilization has proven to be the most important breakthrough in reproductive medicine, failure of implantation in couples undergoing this treatment is a common occurrence and hence the take-home baby rate remains relatively low. Recurrent failure is a distressing situation leading to despair in couples and frustration among physicians. While factors underlying implantation failure are many, most cases remain unexplained.

Our study proposal is unique in that: a. very few studies evaluated environmental toxicants in the follicular fluid of infertile women; b. we plan to determine the differential measurements of these elements in follicles of various sizes with the presumption that smaller follicles may reflect more accurately long-term exposure; c. we plan to establish for the first time in Lebanon the extent of exposure to  pollutants in infertile women through follicular fluid measurements; d. we look forwards to unravel some aspects of unexplained IVF failures in women.     



This is a prospective non-interventional study which will determine the concentrations of non-essential heavy metals and organic toxicants in the follicular fluid of 100 women undergoing IVF/ICSI treatment at the American University of Beirut Medical Center (AUBMC) Fertility Center.




ü  Age: 18-42 years at the time of interview.

ü  BMI: 18 to 30 Kg/m2.

ü  Normal uterine cavity (as assessed by hysteroscopy or HSG).

ü  Normal hormonal investigation: TSH, PRL, FBS.



ü  Preexisting medical condition (thyroid disease, diabetes mellitus, hypertension, pulmonary conditions, cardiac condition…).

ü  Azoospermia (Absent sperm in ejaculate).

ü  Moderate to severe endometriosis.

ü  Ultrasound-visible hydrosalpinx.