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2 Ovarian rejuvenation is a procedure that may create new eggs in the ovaries of women who are unable to conceive because of early menopause, advanced maternal age or low oocyte (egg) reserve, yet who wish to have their own biological child. These individuals are either unable or unwilling, for their own personal reasons, to use donor eggs or to adopt a child. New eggs do not develop in the ovaries under normal circumstances, and, according to the current scientific understanding of ovarian physiology, a woman is born with all the eggs that will be available for conception during her reproductive life. Furthermore, it is a scientifically undisputed fact that a woman's supply of eggs diminishes both in number and genetic quality as she ages. Although it is not possible for new eggs to be produced naturally, the proposed treatment is based upon a recently published case report* which suggests that new eggs can be produced with the treatment described by the authors of this paper. They reported that a 49 year old postmenopausal woman conceived and delivered a genetically normal, healthy baby after having had a preparation of her own blood cells injected into her ovaries. Such a report naturally creates healthy skepticism. However, this paper was submitted by legitimate physicians, of professorial rank, at an academic medical institution in Cairo, Egypt.** This paper was presented at a recent international scientific meeting in Germany, in November 2013.*** Given the scientific legitimacy of the authors and the credibility of their institution, scientific fraud is an unlikely possibility. However, the possibility of a coincidental spontaneous conception must be considered. Spontaneous conceptions occurring at the age of 49 have happened, but the actual statistical probability of its occurrence is minuscule. When the rare conception does occur at this age, the pregnancy is always miscarried at a very early stage due to genetic abnormalities, reflecting the poor genetic quality of aged eggs. The birth of a genetically normal infant makes spontaneous conception, unrelated to the ovarian rejuvenation treatment, extremely unlikely. Spontaneous conception was even more unlikely in this particular woman because she did not have a menstrual period for four years prior to conception and had never conceived in 30 years of marriage.

3 The scientific basis of this case report of successful ovarian rejuvenation is most likely that the patients' blood cells, which were injected into her ovaries, produced substances called Growth Factors, which the body normally produces in order to heal both internal and external injuries. Among many other important biological and immunological functions, Growth Factors cause the growth of new blood vessels, connective and nerve tissues by the activation of Stem Cells that are normally found in all parts of the human body. Stem Cells can, under the proper biological stimulus, morph into any type of cell in the human body, including eggs. The presence of Stem Cells in the ovaries and their transformation into mature oocytes (egg cells) has been demonstrated in mice by Harvard researchers. Stem Cells have also been shown to be present in the human ovary, so it is quite possible that they can be transformed into eggs by Growth Factors contained in the individuals' own white blood cells and platelets which have been injected into the ovary. Injections of Growth Factors, when used for many other types of medical treatments, are made from a patient's own blood and blood cells and is called PRP (Platelet Rich Plasma) or PDGF (Platelet Derived Growth Factors) Therapy. Growth Factors are produced naturally by certain blood cells (platelets and white blood cells) when the body is injured, in order to naturally repair the body's tissues. Remember in your childhood, "skinning" your knee and seeing a thick yellow substance form over the injured area? That was actually a combination of platelets, white blood cells, blood clotting and growth factors that stop the bleeding, prevent infection, and eventually cause the formation of new skin, blood vessels, connective tissues and nerves to replace those which were lost as a result of the injury. PRP injections have been used clinically for many years by physicians for the treatment of soft and connective tissue injuries, as well as in bone grafts. Many professional athletes use this therapy to accelerate the healing of their sports related injuries. PRP's are also used in burn patients to help skin grafts take and after cardiac surgery to help the chest wall incisions heal. The current clinical use of PRPs is very wide--from treatment of leg ulcers to non- surgical facelifts. Of course there are research studies that both confirm and deny the efficacy of PRP therapy in its many and varied medical uses. One thing about PRP therapy that has not been challenged is its safety. Since it is made from a person's own blood, there can be no transmission of blood borne viruses such as Hepatitis or HIV, as has been reported with use of products made from the blood of other individuals. Moreover, since there are no synthetic chemicals involved and PRP therapy is made from the patients' own blood products; the possibility of an allergic reaction is extremely unlikely.

4 The process of ovarian rejuvenation involves two steps. The first is the preparation of your PRP. The next part of the ovarian rejuvenation process is the injection of the PRP into the ovaries. The major difference in our study and the technique described in the referenced case study is that we use a non-surgical approach to the ovarian injections. In the referenced case report, the authors used a surgical procedure, Laparoscopy, to visualize the ovaries directly and inject the cells under direct visualization. Laparoscopy, being a surgical procedure, involves a small incision, requires general anesthesia and longer operating and recovery time. The technique that we have developed to inject the cells into the ovaries is a nonsurgical, transvaginal ultrasound- guided injection performed under sedation with an anesthetic agent called Propofol. This is basically the same as the procedure that is used for an egg retrieval in the In Vitro Fertilization. In our experience, our approach is less invasive, safer, and has a shorter, more comfortable recovery. We have performed thousands of IVF egg retrieval procedures in the last 25 years, which, in our experience, has a wellestablished safety record, with an extremely low complication rate. The benefit of this procedure is the possibility of achieving pregnancy with one's own eggs, which had not been possible prior to this procedure. Since this is an innovative medical treatment, it must be understood that there is no guarantee, stated or implied, that pregnancy, either naturally, or as a result of any subsequent fertility procedure, will occur. If pregnancy does occur, there can be no guarantee as to the genetic composition or the health of any offspring that is conceived after this procedure. The risks of this procedure are minimal, and are basically the same as those for an egg retrieval procedure, which is part of the In Vitro Fertilization process. The possible side effects are pain after the procedure, which usually resolves in 1-2 hours with pain medication, fever or internal bleeding. Although complications are rare, they may possibly result in hospitalization.

5 Any woman who is in good physical health and falls into one or more of the four patient categories that will be studied will be evaluated for admission to this study. Menopausal or perimenopausal women under the age of 50 years. Infertile women, over the age of 35 years, having low egg reserve and low AntiMullerian Hormone levels. Women under the age of 35 years, who have low egg reserve and low AntiMullerian Hormone levels Women with premature ovarian failure (POF). In women who do not get periods, the procedure can be performed at any time. In women who do get periods, either regularly or irregularly, the procedure is best performed during the menstrual period or early in the cycle, prior to the development of an egg follicle. The procedure can be performed as early as the day of the initial evaluation. Prior to undergoing the procedure, you must not eat or drink anything for a period of 8 hours prior to the procedure, since an anesthetic is used. On the day of the procedure your blood will be drawn for the preparation of your PRP. The anesthesiologist will insert an intravenous line and you will be an asleep for approximately 10 minutes while the procedure is performed. Transvaginal ultrasound guided technique is used to inject a small amount of fluid containing your white blood cells and platelets into each ovary. After the procedure you will sleep for 1-2 hours, at which time you will be ready for discharge, to be accompanied by a family member or friend to escort you to your home or to your hotel. Occasionally, ovarian pain will be experienced after the procedure, which will be treated with pain medications and will resolve 99% of the time within 1-2 hours.

6 In order to monitor if the procedure has regenerated new eggs in your ovaries, AMH (antimullerian hormone), FSH,LH and Estradiol levels are measured at monthly intervals in women who do not menstruate, and during the menstrual flow in menstruating women for a period of six months. If the AMH levels rise, while the FSH,LH, and estradiol levels become lower, there is objective evidence of ovarian rejuvenation is demonstrated. The follow up blood studies can be performed in our office or at your local Quest Laboratory blood drawing station. Participants are asked to report the presence of spontaneous periods in menopausal women or any change in menstrual patterns in those participants who do have menstrual cycles. Any possible signs or evidence that pregnancy has occurred must be reported to us immediately. In those participants in the New York City vicinity, we will monitor any early pregnancies. For those women living in distant areas or abroad, we will provide instructions and advice concerning follow up, early pregnancy monitoring and care. It is important to remember that any therapeutic effect of Growth Factors may take 3-6 months to be observed, since the any type of tissue transformation will not be immediately obvious. Even if ovarian rejuvenation is observed, pregnancy may not necessarily occur, since there may be other factors that could interfere with natural conception. If there is evidence of oocyte rejuvenation, the patency of the Fallopian tubes should be confirmed and the male partner reevaluated with a semen analysis and a post coital test. If these tests show that natural conception is unlikely, we will recommend appropriate treatment.

7 For decades, women have had to endure the loss of sensation and the development of urinary leakage after childbirth and advancing age. This effect is largely due to the loss of microcirculation that starves the nerve endings and support tissue in the upper vaginal wall., With the discovery of the rejuvenating and restorative effects of Platelet-Rich Plasma (PRP) in other body tissues the use of PRP in the vaginal tissue that was stretched and torn over time and from childbirth makes perfect sense.

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9 Please Call Middle East and Gulf Area scientific office Or Contact DCare DCare The Leader in Tissues Regeneration