Biogenist Pharma Main Player in Infertility Treatment-PDF

8/14/2019 Biogenist Pharma Main Player in Infertility Treatment-PDF

1/58


2/58

.


3/58

.


4/58

.


5/58

Company IntroductionBiogenist (Pvt) Ltd started its operation in the year 2004.

It is a part of a group of companies engaged in diversified businesses.

Our initial focus is on the specialty of Obs / Gynee particularly Infertility

Management.

Biogenist has also entered into the Branded Generic Segment with the aim ofproviding effective & economical medicines for the entire community

.

.


6/58


7/58

Vision

By 2016 Biogenist will be known to

the Practicing Gynecologists as a

company caring the entire basichealthcare needs of a common

person.


8/58

All Infertility Centers of Pakistan Lahore Institute of Fertility & Endocrinology (LIFE) Lahore

Australian Concept Infertility Medical Center - Karachi

Baqai Institute of Reproductive Sciences (BIRDS) Karachi

Sind Institute of Reproductive Medicine (SIRM) - Karachi

Islamabad Clinic Serving Infertile Couples (Pvt) Ltd - Islamabad

Infertility Services (Pvt) Ltd - Islamabad

Gynecological Advisory Services - Islamabad

Aga Khan University Hospital

Armed Forces Institution of Pakistan

Practicing Gynecologists

.

Our Working Spectrum


9/58.


10/58

Biogenist Pharma

Chief Executive

Officer

. 1


11/58. 1

THANK YOU

Biogenist Pharma (Pvt) Ltd


12/58


13/58


14/58

. 14

Infertility is a very common condition affectingapproximately 13-14% of couples in the reproductive

age group. Although this prevalence has remained stable over the

last few years, the demand for infertility services hasincreased substantially.

This increase is due primarily to the Baby Boomgeneration entering into the reproductive age group ata time of highly publicized technological advances.


15/58

. 15

Definition of Infertility & ART

Common causes of infertility

Who is eligible for ART

Methodology of ovulation induction Improving SPA

Other techniques

Counseling couple Failure rate

Cost effectiveness


16/58

. 16

Infertility is defined classically as the inability to

conceive after 1 year of unprotected intercourse.This definition is based on the cumulativeprobability of pregnancy:


17/58

. 17

Month Monthly Probability Cumulative Probability

1 0.2 0.20

2 0.2 0.36

3 0.2 0.49

4 0.2 0.595 0.2 0.67

6 0.2 0.74

7 0.2 0.79

8 0.2 0.83

9 0.2 0.8610 0.2 0.89

11 0.2 0.91

12 0.2 0.93


18/58

. 18

ART refers to all techniques involvingdirect retrieval of oocytes from theovary

ART procedures include IVF, GIFT,ZIFT, and ICSI.

The simplest ART procedure, IVF hasbeen around for over 20 years and is

perhaps the most commonlyrecognized ART of all procedures.


19/58

. 19

Causes of Infertility

Cause Couples Women

Male 35% N/A

Ovulatory 15% 40%

Tubal 35% 40%

Unexplained 10% 10%

Other 5% 10%


20/58

. 20

Female factors

Cervical factor

Ovulatory factor (PCOs)

Uterine factor (endometriosis)

Pelvic factor


21/58

. 21

Polycystic Ovarian Syndrome (PCOS)Also known as Stein-Leventhal syndrome

Also known as hyperandrogenic chronic anovulation is a benign

disorder that commonly results in infertility.PCOS is characterized by irregular ovulation and menses, obesity,insulin resistance, acne, and hirsutism.Most women with PCOS also have ovaries filled with multiplebenign cysts.


22/58

. 22

How does PCOS contribute to Infertility?

Impaired fertility is a prominent feature of PCOS.

This is believed to result from elevated insulin levels that

stimulate excess androgen production by the ovaries.

The androgens cause premature follicular wasting whichcauses inconsistent or absent ovulation, which is

associated with infertility.


23/58

. 23

Symptoms

Irregular or absent periods

Lack of ovulation Weight gain Hirsutism (excessive hair growth) Insulin resistance Acne Male-pattern balding

Multiple small ovarian cysts-these may be seen by an ultrasoundexamination

Ancthosis nigrans (darkening of the skin at the nape of the neck andunder the arms and breasts).
http://images.google.com.pk/imgres?imgurl=http://2.bp.blogspot.com/_B9CmlJEV37o/SXazrxkC7RI/AAAAAAAAAEc/CfB5wHruscg/s320/05.jpg&imgrefurl=http://yogaforobesity.blogspot.com/2009/01/pcod-disease-that-worries-woman.html&usg=__cOGyQmck6zIsf1y-q5GZx84YDEs=&h=275&w=312&sz=19&hl=en&start=1&um=1&itbs=1&tbnid=8_BKaDuoaHTrRM:&tbnh=103&tbnw=117&prev=/images?q=PCOD&um=1&hl=en&sa=G&tbs=isch:1


24/58

. 24

Diagnosis

:Blood Work/Hormonal Testing:

Laboratory testing is important for diagnosis but it is

crucial to look at multiple values collectively.


25/58

. 25

Diagnosis:

3. Ultrasound:

Ultrasound of the pelvis is typically performed when the

clinician suspects PCOS.

If >10 cysts are found in either ovary that are less than10mm, this meets the ultrasound criteria for PCOS.Furthermore, polycystic ovaries are typically 1.5 to 3 timesthe normal size.

Just the presence of polycystic ovaries, without symptomsand/or consistent blood work, does not confirm a diagnosisof PCOS.


26/58

. 26

Treatment

Weight Loss, Progestins, Oral Contraceptives,

Anti-Androgens, GnRH agonists, Fertility drugs,

Surgical therapy:

a) Ovarian wedge resection b) Laparoscopic ovarian drilling


27/58

. 27

Endometriosis

Endometriosis can be defined as a nonmalignantdisorder in which functioning endometrial tissue ispresent outside the uterus.

The incidence of this disease ranges from 10-15% inwomen between the ages of 25 and 44 who areactively menstruating, but it also occurs in teenagers.

It is estimated that 25-50% of infertile women havethis disease.


28/58

Endometriosis

. 28

The incidence is higher in first degree relatives of

women with endometriosis, which suggests that

heredity may play a role.

In addition, there is also a higher prevalence of the

disease in women who delay childbearing or who are

of Asian descent.


29/58

. 29

Causes and Symptoms

The cause of endometriosis is unknown, however there areseveral theories.

The first theory is known as retrograde menstruation, or themovement of sloughed endometrial tissue back through thefallopian tubes and into the abdominal cavity. This tissue canthen attach itself to various internal organs or tissues outside ofthe uterus.

Immune system dysfunction. It is believed that certain womenmay develop endometriosis due to deficiencies in their immunesystem.

Endometriosis


30/58

. 30

In women without endometriosis, the immunesystem destroys any ectopic implants that maydevelop. However, in women with endometriosis,there is an altered immune response and the body isunable to destroy the growth of the implants.

Furthermore, some scientists believe thatendometriosis is an autoimmune disorder. Thismeans that the body makes antibodies toendometrial cells. These antibodies may destroy the

healthy endometrium found in the uterus, but areineffective in destroying ectopic implants.

Endometriosis


31/58

. 31

Symptoms

Pelvic pain and cramping before and duringperiods

Pain during intercourse

Inability to conceive

Fatigue

Painful urination during periods

Gastrointestinal symptoms such as diarrhea,constipation, and nausea

Endometriosis


32/58

. 32

There are other medical conditions that have similarsymptoms and should be considered prior to making adiagnosis of endometriosis. Conditions that may causegeneralized pelvic pain include:

Pelvic inflammatory disease (PID) Pelvic adhesions

Neoplasms (cancers), both benign or malignant

Ovarian torsion

Sexual or physical abuse

Other causes that are not gynecologic in nature

Endometriosis


33/58

. 33

How does endometriosis contribute toinfertility?

The cause of infertility is believed to result from the

scarring and adhesions that form in the reproductivetract as a result of inflammation.

Scar tissue and adhesions may reduce fertility by either

obstructing or distorting the shape of the fallopian

tubes, which in turn impedes the passage of sperm to

the egg.

Endometriosis


34/58

. 34

In the event that sperm do reach the egg, they

may encounter a hostile environment

unfavorable to fertilization.

Finally, scarring from endometriosis may

obstruct the fallopian tubes so that if an egg is

fertilized, it may be unable to travel to the uterus

for implantation.

Endometriosis


35/58

. 35

Diagnosis

One of two techniques may be used to confirm thediagnosis of endometriosis. Both procedures involvevisualization of the pelvic cavity in order to confirm

the presence or absence of ectopic implants. laparoscopy

laparotomy

If there are any suspected ectopic implants, they arebiopsied in order to determine the presence of

endometrial cells.


36/58

. 36

Women with tubal diseases

Unexplained infertility

Endometriosis

Immunologic causes for infertility

Women with premature ovarian failure

Individuals with male factor infertility (e.g.,abnormalities in sperm production, function

or transport or prior vasectomy)


37/58

. 37

Basically, this term refers to the use of medications

to stimulate your body to produce one or more

eggs.

Ovulation induction can be as simple as taking a

daily pill or more complicated, like injecting

fertility medications and seeing your specialist

daily for necessary monitoring. The simplest form

of ovulation induction involves taking clomiphene.


38/58

. 38


39/58

. 39

More potent medications, known as the gonadotropins,are available for more intensive ovulation induction.

Gonadotropins are injectable medications that are madeup of a combination of follicle stimulating hormone (FSH)and luteinizing hormone (LH) or just FSH alone.

These hormones can be very helpful in getting a woman to

produce and release her eggs.


40/58

. 40

The success of ovulation induction in achieving a

pregnancy is highly variable. It depends on the

diagnosis, age, the medication being used, and

numerous other factors.


41/58

. 41

Sperm penetration assay (SPA) is a multi-step laboratory

test that offers a biological assessment of human spermfertilizing ability.


42/58

. 42


43/58

. 43

ZIFT

GIFT

TEST

POST

ICSI

TESE

MESA

PGD


44/58

. 44

ZIFT

Zygote Intrafallopian Transfer. ZIFT may berecommended if the husband has severe male fertility factor or if there has been difficulty confirming

fertilization with past procedures. ZIFT has theadvantages of allowing fertilization to be confirmedand it has demonstrated higher success rates thanIVF when used for the appropriate indications.

One disadvantage with ZIFT is that the transfer of the

zygote must be performed through a laparoscope.


45/58

. 45

GIFT

Gamete intrafallopian transfer was developing in 1984 as avariation of in vitro fertilization (IVF).

Gift is recommended when

unexplained infertility

infertility due to immunological factors

endometriosis

selected cases of male infertility

Tubal infertility

A requirement for the procedure is that the female partnerhaving at least one open (patent) fallopian tube.
http://images.google.com.pk/imgres?imgurl=http://www.netterimages.com/images/vpv/000/000/004/4082-0550x0475.jpg&imgrefurl=http://www.netterimages.com/image/4082.htm&usg=__ldH7Cz99ssa1MptPlIhI7YA9F8k=&h=550&w=475&sz=105&hl=en&start=176&um=1&itbs=1&tbnid=r2cVh2qXe7OqxM:&tbnh=133&tbnw=115&prev=/images?q=ZIFT&start=160&um=1&hl=en&sa=N&ndsp=20&tbs=isch:1http://images.google.com.pk/imgres?imgurl=http://www.netterimages.com/images/vpv/000/000/004/4082-0550x0475.jpg&imgrefurl=http://www.netterimages.com/image/4082.htm&usg=__ldH7Cz99ssa1MptPlIhI7YA9F8k=&h=550&w=475&sz=105&hl=en&start=176&um=1&itbs=1&tbnid=r2cVh2qXe7OqxM:&tbnh=133&tbnw=115&prev=/images?q=ZIFT&start=160&um=1&hl=en&sa=N&ndsp=20&tbs=isch:1


46/58

. 46


47/58

. 47

ICSI

Intracytoplasmic sperm injection, or ICSI, was

developed to treat couples who previously had a verypoor probability of achieving fertilization due to the

male partner's extremely low numbers of viable

sperm.

This treatment, when combined with in vitrofertilization, allows these couples a more favorable

probability of achieving conception.


48/58

. 48

ICSI


49/58

. 49

TESE

Testicular Sperm Extraction

MESA Microsurgical Epididymal Sperm Aspiration

What is Preimplantation Genetic Diagnosis?


50/58

. 50

PGD

Preimplantation Genetic Diagnosis

The Preimplantation Genetic Diagnosis (PGD) is a new method ofPrenatal Diagnosis. The aim of this study is to increase the chances of

having a healthy baby and therefore, avoiding the chances of

transmitting a genetic or hereditary disease. In order to perform the

diagnosis we use high technology with each embryo
http://www.geneticsandsociety.org/img/original/pgd2.jpg


51/58

What is Preimplantation Genetic Diagnosis?


52/58

. 52

PGD

Preimplantation Genetic Diagnosis

Preimplantation Genetic Diagnosis is recommended

for those couples who are carriers or suffer from

genetic or chromosomal diseases that aretransmissible to their offspring. It is also

recommended for women of an advanced age, for

women who have had repeated miscarriages, for

patients undergoing fertility treatments who have failed several times to conceive through In Vitro

Fertilization and finally for those couples who produce

embryos with morphological alterations
http://www.geneticsandsociety.org/img/original/pgd2.jpg


53/58

. 53

The use of skills that enable a client to recognize andidentify his (sic) own problems, and the ability to helpclient find his own solution or resolution.

The Human Fertilization and Embryology Authority

(HFEA) state in their code of practice that three sortsof counseling must be available at licensed treatmentcenter. These are:

Support counseling

Implications counseling Therapeutic counseling


54/58

. 54

One of the first questions that most people ask is "what isthe chance for success?" The best estimate is that thebirth of a live baby occurs in approximately 15-25% of

women in whom embryos are transferred into the uterus. The 1998 nationwide live birth rate as reported in the IVF-

ET Registry, was 24.9%.

The corresponding rate for 1989 was 14%.


55/58

. 55

Success varies with many factors, including the numberof embryos that are transferred.

If one embryo is transferred, there is approximately a

7% chance of successful implantation; with twoembryos, the success rate increases to 18%.

The rate peaks with the transfer of three to fourembryos. Presently, the collection of oocytes,fertilization, and early embryo growth are accomplished

with a high degree of efficiency.


56/58

. 56


57/58

. 57

Twins occur in about 25% of ART pregnancies versus 1-2%of spontaneous pregnancies. The risk of more than atwin pregnancy is less than 5%.

To put these figures into perspective, studies have shownthat the rate of pregnancy in couples with proven fertilityin the past is approximately 20% per cycle. Therefore,although a figure of 15-25% may sound low, it is equal toor greater than the chance that a fertile couple will

conceive in any given cycle.


58/58

We are all angels with only one wing.

We can only fly while embracing each other.

- Luciano D. Crecenzo

Thank you!

Documents

Biogenist Pharma Main Player in Infertility Treatment-PDF