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Few Questions

What is the composition of BAP C? Do we add something to prepare BAP C?

BAP C is a cocktail of cytokines and growth factors. No added chemical/preservative is used to prepare BAP C. BAPC is prepared from concentrated platelets prepared from fresh peripheral blood which is collected from a peripheral vein, stored in anticoagulant and processed to separate various components of blood. From the above separations, platelet fraction alone is concentrated further and through activating platelets cytokines and growth factors (GFs) become bioactive and are secreted within 10 min after activation process. These factors include platelet-derived growth factor (PDGF), vascular endothelial growth factor (VEGF), transforming growth factor (TGF), and epidermal growth factor (EGF). They can regulate cell migration, attachment, proliferation and differentiation, and promote extracellular matrix accumulation.

What precautions is being followed for the safety of blood sample carried from clinic and BAP C delivered. What standard safety protocol we follow?

We follow SOP for every blood sample being carried out of the clinic/hospital like every other laboratory which manages to do home collection. We do not perform batch processing. Each individual sample is processed with an unique labeling and coding & then processed.

How you will manage is in a day if more than 10 sample have to be processed?

Our lab can handle up to 20 samples per day, which is our maximum utilization capacity.

Whether the effect of BAP C on endometrium will continue in the consecutive cycle

Yes; It does.

Is there any published report available on BAP C ?

We have our own non- randomized controlled trial for our early 60 patient group; which has shown more than 95% success in the conditional improvement of the thin endometrium and more than 72% success in clinical pregnancy. Our Randomized controlled trial shall start very soon, which shall be published in a leading indexed pubmed journal.

In case 2 Vial of BAP C being used and pregnancy is not successful. Can the 3rd Vial be sufficient in next consecutive cycle?

The third vial can be used in the consecutive cycle. Your doctor will decide whether you need a fresh sample of BAP C or not.

Upto how many days BAP C can be stored?

Like your frozen embryos the BAP C can be stored in liquid nitrogen for many months.

Is the content of BAP C differing from subject to subject?

No.

Can BAP C be prepared from of one person and used in other person? Will it result in any incompatibility issue?

BAP C strictly speaking is acellular; meaning, it does not contain any cells, thereby no stimulation through antigenic-antibody reaction. Technically it can be used, but we would not advise.

What is BAP C? Is it the same as PRP?

BAP C is known as Biologically active Peptide Concentrate. It is a concoction of cytokines and growth factors prepared from patient’s own blood.

It is not PRP. PRP also known as Platelet Rich Plasma contains not only platelets but also other blood components like lymphocytes which are pro-inflammatory.

Can BAP C be used in multiple IVF cycles? How long will the potency last?

Yes it can be used in multiple IVF cycles. The potency will continue into the successive cycle as well.

How is BAP C preserved until it is utilised?

BAP C is preserved in liquid nitrogen and hence its shelf life is for many months if not used.

How far reaching are the effects of BAP C?

The effects of BAP C shall continue into the successive cycle as well.

Will BAP C have a positive effect on the overall health of the Reproductive System?

Yes, it does. It overall improves the regenerative health.

Will the proliferation of cells due to administration of BAP C be cancer producing?

No it does not. Since autologous blood is used, there is no antigenicity/inappropriate stimulation is involved.

Are there any side-effects as a result of using BAP C?

We have used BAP C for over 200 patients over the past two years. We have not encountered even one side effect in any of our patients.

Are any approvals required for adopting / using BAP C?

No it does not, since it is a process innovation and only autologous blood is not used. It does not come under any legal framework for the above mentioned reason.

What is the shelf life of BAP C?

Like frozen embryos, the shelf life of BAP C can last many months since it is stored in the liquid nitrogen.

Can BAP C be a cure for Secondary Amenorrhea?

BAP C is used for POR ( Poor Ovarian Reserve ) a condition which may be responsible for early menopause. Not all conditions resulting in secondary amenorrhoea may benefit from BAP C, which obviously has its limitations.

Can BAP C address the problem of Anemia?

No.

In POR cases, the size of the ovaries are shrunken. Hence it would be difficult to access them, while injecting BAP C, through an US guided procedure. How does one circumvent?

Good question. If you feel that the ovaries are very small or you do not have expertise do so, then you can inject BAP C into the ovaries through a laparoscopy procedure.

You say two 1.5 ml vials of BAP C will be provided to be injected into each ovary, to treat POR. The Oocyte retrieval apparatus is recommended to be used. But the length of the needle and tube will mean that the volume of BAP C is likely to remain in the apparatus. How does one handle this situation?

Very good question. That is why we give you about 2 to 3 ml of plasma in addition for you to inject the BAP C into the ovaries. The plasma is safe enough to be injected along with the BAP C.

In your internal study, did you do a Double Blind test on an equal number in the control group?

No. It was a validated non-randomized retrospective study.

Are there any studies which discuss the efficacy of Estrogen versus BAP C?

An hormone cannot be compared with a regenerative medicine solution like BAP C. Moreover BAP C is the first of its kind in the whole world, so obviously there cannot be any comparative study between BAP C and Estrogen.

Does Endometrial thickness predict pregnancy?

No. It does not predict the outcome of the pregnancy. However a thick and a healthy endometrium is vital for successful implantation of the embryo.

Is it possible to infuse BAP C when Intrauterine Devices (IUDs) are present?

No. IUDs have to be removed.

On what day of the menstrual cycle should the BAP C treatment be begun? What is the window period upto which the treatment could be started? What is the frequency of administering BAP C?

BAP C is advised on the 5th menstrual day of the current cycle. It can be safely administered even on Day 6 or Day 7 of the menstrual cycle or the day when there is minimal spotting. BAP C should be administered as a IUI procedure in 3 doses of 0.8ml each. First dose on Day 5 to Day 7; Second dose ; 5 days after the first dose and the third dose ; 2 days before the embryo transfer.

Can BAP C be administered subcutaneously?

No. The routes of administration are intra-uterine and intra-ovaries.

If the woman already has a thin endometrium, how is the BAPC prepared from her aspirated blood going to help the regeneration of the endometrium? Will not the percentage of the GFC be already low in such women?

Another very good question. Our BAP C contains growth factors multiple times that of the growth factors present in one’s body. Moreover our BAP C is directly infused into the thin endometrium where it produces hyperlocal effects of the endometrial regeneration.

What is POR and what are the signs of POR?

Poor ovarian reserve (POR) indicates a reduction in quantity and quality of oocytes in women of reproductive age group. POR is an important limiting factor for the success of any treatment modality for infertility. It It may be age related as seen in advanced years of reproductive life or may occur in young women due to diverse etiological factors. Evaluating ovarian reserve and individualizing the therapeutic strategies are very important for optimizing the success rate. Majority or women with POR need to undergo in vitro fertilization to achieve pregnancy. However, pregnancy rate remains low despite a plethora of interventions and is associated with high pregnancy loss. Early detection and active management are essential to minimize the need for egg donation in these women.

The following are the clinical indicators of POR.

  • Decreased menstrual cycle duration
  • Increased FSH levels
  • Decrease antral follicular count
  • Decreased AMH levels
What do you mean by Ovarian Rejuvenation treatment?

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.

I was told by my doctor that I am born with finite number of Eggs? Is it true? If it is true and since I am diagnosed with POR, How does ovarian rejuvenation help me?

It is true that every female is born with finite number of eggs. However ad per latest research Ovarian rejuvenation will help you to produce healthy and as well as new eggs. 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 PDGF (Platelet Derived Growth Factors) or BAPC (Biologically active peptide concentrate) Therapy.

My doctor keeps talking about Growth factors. I do not understand. Could you please explain?

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. BAPC injections have been used clinically for many years by physicians in the form of platelet rich plasma 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. BAPC’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 BAPCs 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 BAPC therapy in its many and varied medical uses. One thing about BAPC 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 BAPC therapy is made from the patients’ own blood products; the possibility of an allergic reaction is extremely unlikely.

How is the ovarian rejuvenation procedure performed?

The process of ovarian rejuvenation involves two steps. The first is the preparation of your BAPC. This begins with at the insertion of a needle into your vein in order to obtain several tubes of your blood. Your white blood cells and platelets are separated from the red blood cells and serum by a procedure called centrifugation. After separating the platelets from RBC and other cell types, platelet fraction will be concentrated by another round of centrifugation. Post this, the concentrated platelet solution will be subjected to proprietary chemical free activation process followed by filtration of the BAPC. The preparation of your BAPC takes less than one hour. The next part of the ovarian rejuvenation process is the injection of the BAPC into the ovaries. There are two ways of injecting BAPC into ovaries: a non-surgical approach to the ovarian injections and 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. Non-surgical approach is to inject the cells into the ovaries by transvaginal ultrasound- guided injection performed under sedation with an anesthetic agent. This is basically the same as the procedure that is used for an egg retrieval in the In Vitro Fertilization. Non-surgical approach is less invasive, safer, and has a shorter, more comfortable recovery. Laparoscopy though it is a surgical procedure, better visualization of ovaries can be made for injection of BAPC. The choice of the procedure is based on the discussion between the doctor and the patient and based on the need.

What are the potential risks and benefits of the procedure?

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.

Who are candidates for this procedure?

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 with premature ovarian failure (POF).

If you feel that you are a potential candidate and wish to be treated, please fill out the application form that is included in downloads, sign the consent form and return it to your consulting doctor. A recent day 2, 3,or 4 FSH,LH, and Estradiol levels, as well as an AntiMullerian Hormone level is required. If you have not had these tests performed, request a prescription from your physician, and have the tests done at a convenient nearby diagnostic laboratory. Once the reports are ready, please plan your initial evaluation and consultation. The preliminary consultation will include a vaginal sonogram to evaluate your current ovarian reserve and to see if your ovaries are in a favorable location for the ovarian injection procedure. The sonogram will also show if ovarian cysts or other pathological conditions exist which may negatively impact the performance of the procedure.

How is the ovarian regeneration procedure performed?

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 (30-40ml) will be drawn for the preparation of your BAPC. 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. 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.

How does one monitor POR?

Your doctor shall monitor you clinically and biochemically for the first 60 days post BAP C injection; 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 at the clinic or local diagnostic laboratory. 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 the doctor immediately. 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.

Can I opt for natural methods of conception post 60 days of the injection of BAP C?

Yes you can opt for natural ways of conception post 60 days of the injection of BAPC, subject to your clinical and biochemical improvement and you shall be advised upon that by your doctor.

If an IVF cycle is opted for, when does one go for egg retrieval?

Your doctor shall decide the best date for your egg retrieval.

If BAP Cis not providing the required results, can you refund the process charge?

BAP C is administered to you after you have undergone many treatment options which have not resulted in your pregnancy. BAP C a regenerative medicine product of more than 10 years of clinical research is a boon for patients like you who have difficulty in conceiving. The problem could be anything from non-responsive thin endometrium resulting in repeated implantation failure or Poor Ovarian Reserve. BAP C success rate is more than that of the current industry standards and the chances of you becoming pregnant is very high. Moreover a lot of technology is involved in the process innovation of BAP C. Henceforth it may not be possible to refund the process charges.

Do you have a proven study for BAP C?

We have our own internal validated non-randomized retrospective study in which we have found success of more than 95% in the conditional improvement of the endometrium and more than 72% success in clinical pregnancy.

Do you have any proven record that it does not affect the IUI or IVF protocol?

Our success story is enough. Over 200 patients have undergone BAP C without any side effects and all the doctors who have adopted the BAP C so far has not come forward with any untoward results/events affecting their treatment protocol.

How BAP C differs from PRP?

BAP C is not PRP. BAP C is acellular and contains only cytokines and growth factors which are derived from both activated platelets (growth factors are released from the alpha granules of the platelets) and plasma. Whereas, PRP known as Platelet rich plasma is cellular and contains not only platelets but also lymphocytes which are pro-inflammatory negating the anti-inflammatory effects of platelets.

Do I have to take any special precautions before taking the treatment of BAP C?

Not necessarily. Overnight fasting is not required. Your doctor shall advise you not to empty your bladder for better visibility through Ultrasound during the procedure.

Do I have to stay in the hospital?

Not at all. It is like a simple IUI procedure, where you can leave within an hour after the procedure if BAP C is used for thin endometrium. However you may be asked to lie down in hip elevated position for about 30 minutes. In fact you can even take shower the next day. However if BAP C is used through a laparoscopy you doctor will advise you the amount of hours you have to stay in the hospital. Even then you may not be admitted.

Will you do any special tests to find out whether I am an eligible candidate to undergo BAP C treatment?

We do simple Ultrasound and biochemical tests to assess the condition of your endometrium and ovaries.