SPERM BANKING

BY

DR FAIZ AHMAD

History: 1776 - First observations on the effects of freezing temperatures on human

sperm .

1866 - First banks for frozen human semen suggested.

1949 - Glycerol first used as protective agent for bovine spermatozoa.

1953 - "Dry Ice" preservation method developed by Bunge and Sherman -

First successful human pregnancy using frozen sperm.

1953 Bunge and Sherman, using dry ice for freezing and storing semen,

reported the first successful human pregnancy resulting from insemination

with frozen human semen..

Since that time, new and improved methods of freezing and storing semen by

immersion in liquid nitrogen at –I96.5°C (Behrman and Ackerman, I969) have

improved the fertilizing capacity of frozen semen and led to the emergence of a

number of commercial human sperm banks in the United States.

1960 - Sperm frozen and stored using liquid nitrogen .

1972 - First commercial cryobanks founded .

1973 - Normal child born from semen stored for over one year

SPERM BANK

Sperm bank, semen bank or cryobank

a. is a facility or enterprise that collects and stores

human sperm from sperm donors for use by women who need

donor-provided sperm to achieve pregnancy.

b. Sperm donated by the sperm donor is known as donor sperm, and

the process for introducing the sperm into the woman is

called artificial insemination, or third party reproduction.

c. From a medical perspective, a pregnancy achieved using donor sperm

is no different from a pregnancy achieved using partner sperm, and it

is also no different from a pregnancy achieved by sexual intercourse.

d. The primary recipients of donor sperm are heterosexual couples

suffering from male infertility, lesbian couples and single women.

SELECTION CRITERIA FOR SPERM

DONORS• Men of all ethnicities and backgrounds are accepted as donors.

• The donors are healthy men between 18 to 45, from a sound

background, and usually graduates.

• A non smoker, non alcoholic who maintains a healthy life style.

• who is willing to undergo frequent and rigorous testing and who is

willing to donate his sperm so that it can be used to impregnate women

who are unrelated to, and unknown by, him

• They should be able to provide their family's medical history (usually

back to two to three generations

• Blood test for blood grouping, Rh status, HIV, diabetes, hepatitis B &

C & other sexually transmitted diseases

• Screening for genetic abnormalities

• They must be able to make a commitment to the program (usually 6

months to 24 month. )

• This semen is analyzed, and accepted only if it has superior qualities: a

count over 100 million per millimetre; and motility of 70% to 80

• donor must agree to relinquish all legal rights to all children which

result from his donations

Screening of donors

Donors are subject to tests for infectious diseases such as :

HIV (HIV-1 and HIV-2),

Human T-cell lymphotropic viruses (HTLV-1 and HTLV-2),

Syphilis,

Chlamydia,

Gonorrhoea,

Hepatitis B virus, Hepatitis C virus

Cytomegalovirus , Trypanosoma cruzi and Malaria.

Hereditary diseases such as:

cystic fibrosis, Sickle cell anaemia, Familial Mediterranean

fever, Gaucher's disease, Thalassaemia, Tay-Sachs disease, Caravan's disease, Familial dysautonomia, Congenital adrenal hyperplasia ,Carnitine transporter deficiency and Karyotyping .

• The donor will undergo a semen analysis and the sample will be thawed to

evaluate post-freezing/thawing semen parameters.

• Sperm susceptibility to damage with freezing varies between individuals, as

well as between samples of a given donor.

• Donors are selected if the post-thaw semen parameters meet a minimum

standard.

• In general, specimens should contain a minimum from 20 to 30 million motile

sperm per milliliter after thawing.

• Post-thaw motility is generally in the range of 25% to 40%.

Indications for Sperm Donation

1.Therapeutic donor insemination (DI or TDI) is used for.

a)Male infertility ;

Azospermia / Blocked of ejaculatory duct/ testicular failure

Oligospermia/sperm or seminal fluid abnormality

Erectile dysfunction/Undecided testes

b)Genetic/Familial disorders ;

c)Female is Rh-sensitized and male partner is Rh-positive ;

d)Single woman who desires a pregnancy but who lacks a male

partner ;

2.Medical Reasons: which will cause permanent sterilisation

or genetic deffect:

a)Infections,

b) STDs (Sexually transmitted diseases),

c)Testicular or pelvic trauma ,heat, irradiation,

d)Radiotherapy, chemotherapy, drugs, tobacco, alcohol etc,

e) Pre-Vasectomy Sperm Banking,

3.Military & Hazardous Occupation Fertility Preservation:

TYPE OF DONOR

Anonymous donor : where the child / receiving couple will never get to

know the identity of the donor.

Non-anonymous donor: termed as known donor, open identity or identity

release donor,.

Private or "directed" donations : privately and directly from a friend,

family member, by advertising , or through a broker.

Place and method of collection

The contract may also specify the place and hours for donation.

Not to have intercourse or to masturbate for a period of usually 2–3

days before making a donation.

A sperm donor generally produces and collects sperm at a sperm bank

or clinic by masturbation in a private room or cabin, known as 'men's

production room' (UK), 'donor cabin' (DK) or a masturbatorium

(USA).

The donor masturbate or use an electrical stimulator, to produce

ejaculate in a special condom , known as collection condom, also use

to collect semen during sexual intercourse.

Processing and Storage

Sperm banks usually 'wash' the sperm sample to extract sperm from

the rest of the material in the semen.

A cryoprotectant semen extender is added before frozen storage.

One sample can produce 1-20 vials or straws, depending on the

quantity of the ejaculate and whether the sample is 'washed' or

'unwashed'

A semen analysis is performed on each ejaculate.

This includes a complete seminal fluid analysis, quantitating sperm

motility, forward progression, sperm density, and morphology.

All specimens are stored in liquid nitrogen storage tanks (-196 ° C).

Once frozen, the vials are immersed in liquid nitrogen in secure tanks

at a temperature of -196° C (-371° F).

The screening procedure also includes a quarantine period, in which

the samples are frozen and stored for at least 6 months.

After which the donor will be re-tested for the STIs.

This is to ensure no new infections have been acquired or have

developed during the period of donation.

Providing the result is negative, the sperm samples can be released

from quarantine and used in treatments

PRINCIPLE OF CRYOFREEZING

During freezing “ Transition of intra and extra cellular liquid to

solid state occurs spontaneously.

Spontaneous change of the physical state of the entire extra and intra

cellular water is prevented by creating ice crystallization.

Cryoprotectants are used for lowering freezing point so that

intracellular freezing occurs at lower temperature, gives cells more

time to dehydrate.

Two categories of cryoprotectants used, depending on their molecular

size and permeability.

1) Permeating (Small molecules)- Glycerol,DMSO,Ethylenglycerol.

2) Non-permeating (Large molecule) - sugars like Sucrose and

Raffnose, Protein and Lipoproteins.

DMSO appears to be more effective, because it penetrates the cell

better than Glycerol.

Concentration of between 5% to 15% have been used, But 7.5% to

10% is more usual.

• Short-term Semen Cryobanking: freezing and storage of sperm

at a sperm bank for less than one year.

• Long-Term Semen Cryopreservation: Proven, time-tested

techniques enable semen specimens and embryos to be frozen and

stored indefinitely in liquid nitrogen.

Advantages of frozen sperm

No risk of STD and AIDS as the

samples are quarantined for three

months and the donors are retested.

A round the clock availability; no

scheduling bottle neck.

High quality product since it is

tested before and after freezing

Rh negative donors can be used for

Rh negative women

Physical traits of husband and

donor can be matched

Disadvantages of fresh semen

There are no records of the

donors.

It's impossible to match the

physical traits of the donor and

the husband.

Using known donors can lead to

legal , emotional and ego

problems.

The quality of the sample is

always suspect.

It could be difficult to produce a

donor at the critical time and

occasionally a treatment cycle

has to run dry.

• Donor sperm prepared for use by ;

Assisted reproductive technique

1. Artificial insemination :

a) intra uterine insemination(IUI),

b) intra-cervical insemination(ICI),

c) IVF,

d)ICSI,

2.Natural insemination:

SURRVOGACY

Type of artificial insemination

Artificial insemination homologous(AIH): semen of husband is

used,

Artificial insemination donor(AID): semen from a person other

than husband,

Artificial insemination homologues donor(AIHD): mixture of

donor semen and husband semen is used,

Surrogacy

“Surrogacy”, means an arrangement in which a woman

agrees to accept and bear pregnancy either by AI or by the

way of implantation of in-vitro fertilized embryo, with the

intention to carry it to term and handover the child to the

person or persons for whom she is acting as a surrogate.

Traditional surrogacy (Traditional/ Straight): when surrogate

mother is the baby's biological mother.

Gestational surrogacy: when surrogate mother is implanted

with someone else fertilized egg. she accepts pregnancy either by

AI or by implantation of in-vitro fertilized ova at the blasto-cyst

stage. Not genetically/biologically related to the child.

Commercial Surrogacy:

• in which a gestational carrier is paid to carry a child to maturity in

her womb.

• is usually resorted to by higher income infertile couples who can

afford the cost.

• This procedure is legal in several countries including India.

• Commercial surrogacy is also known as ‘wombs for rent’, outsourced

pregnancies’ or ‘baby farms’.

Altruistic Surrogacy :

• Altruistic surrogacy is a situation where the surrogate receives no

financial reward for her pregnancy or the relinquishment of the child.

• But all expenses related to the pregnancy and birth are paid by the

intended parents such as medical expenses, maternity clothing,

accommodation, diet and other related expenses).

The Assisted Reproductive Technology (Regulation)

Bill - 2013Describes procedures for:

Accreditation and supervision of Assisted Reproductive Technology

Clinics & Banks.

Ensuring that services provided by the Assisted Reproductive

Technology Clinics and Banks are ethical.

Medical, social and legal rights of all those concerned are protected

with maximum benefit to the infertile couples or individuals within

a recognized framework of ethics and good medical practice.

PROCEDURES FOR REGISTRATION AND

COMPLAINTS

All ART Clinics ;

Involve in infertility treatment – including IUI, AIH, AID.

Infertility treatment involving the use and creation of embryos outside

the human body.

Processing or storage of gametes and embryo

Research on embryos.

Steps for Registration under ;

Confirmation of contact No. and details of ART Clinics/Banks.

Obtaining the information regarding available infrastructure facilities,

trained manpower and different ART procedure being followed at your

ART Clinic/Bank through prescribed Performa.

Verification of the information provided by the respective ART

Clinic/Bank through a sight visit to be conducted by the competent

experts in the field at the respective ART Clinic/Bank.

On receipt of satisfactory report of the Site Visit Committee, the

Unique Registration Number will be issued.

National Registry of Assisted Reproductive Technology (ART) Clinics and

Banks in India

Application for Registration under State Board

Unique Registration Number Certificate from the National Registry of

Assisted Reproductive Technology (ART) Clinics and Banks in India of

the ICMR.

Bio-data of all the faculty members of the clinic or bank including

Director or in-charge of the clinic or bank.

Copies of the degrees and certificates of all the faculty members of the

clinic or bank including Director or in-chare of the clinic or bank.

Such other information and documents as may be prescribed

Code of practice, Ethical consideration and legal issues

1. Clinics should be registered,

2. Code of Practice: Deals with all aspects of treatment and research done at

registered clinics.

i) Staff: Sufficiently qualified, using proper equipment,

keeping & disposing off the genetic material properly.

ii) Facilities: Proper systems for monitoring and assessing practices to optimize

the outcome of ART.

iii) Confidentiality: All information about clients and donors must be kept

confidential.

iv) Information to patient: All relevant information about patient given to patient.

v) Consent: No treatment without the written consent of the couple.

vi) Counselling: couple must be given a suitable counselling about the treatment.

vii) Use of gametes and embryos: No more than three oocytes or embryos may be

placed in a woman in one cycle

viii) Storage and handling of gametes and embryos:

ix) Research: A accreditation authority must approve all research project.

.

x) Complaints: ART clinic acknowledge and investigate complaints.

3. Responsibilities of the Clinic:

i) Give adequate information about particular treatment.

ii) Maintain, detailed record of donor/recipient for at least ten years/keep

all information confidential.

iii) Take DNA fingerprints of donor /child /couple/surrogate mother,

v) Display the charges at the beginning of the treatment.

vii) Be totally transparent in all its operations.

4. Information and Counselling given to Patients:

(a) Basis, limitations and possible outcome of the treatment proposed,

variations in its effectiveness over time, including the success rates.

(b) Side-effects and the risks of treatment to the women and the child.

(c) Need to reduce the number of viable foetuses in order to ensure the

survival of at least two foetuses.

(d) Possible disruption of the patient's domestic life during the treatment.

(e) Techniques involved and possible pain and discomfort

(f) Cost of treatment

(g) Importance of informing the clinic of the result of the pregnancy,

(h) Right of the child born through ART,

(i) Advantages and disadvantages of treatment after certain attempts,

5. Desirable Practices/Prohibited Scenarios:

No bar to the use of ART by a single woman.

The provision of AIH or ART to an HIV-positive woman would be

governed by the decision of the Supreme court.

The accepted age for a sperm donor 21- 45 yrs and donor woman

between 18-35 yrs.

Sex selection/abortion at any stage after fertilization, or not be permitted,

except to avoid the risk.

Collection of gametes from a dying person will be permitted

if widow wishes to have a child.

No more than three eggs or embryos should be placed in a woman during

any one treatment cycle.

Use of sperm donated by a relative or a known friend shall not be

permitted.

Right to have the fullest possible information from the semen bank on

the donor such as height, weight, skin colour, educational qualification,

profession, family background, freedom from any known diseases or

carrier etc.

Trans-species fertilization involving gametes of two species is prohibited.

Ova derived from foetuses cannot be used for IVF but may be used for

research.

Semen from two individuals must never be mixed before use, under any

circumstance.

The data of ART clinic must be accessible to ICMR at the national level.

The true informed consent should be made on the consent form,

witnessed by a person who is in no way associated with the clinic.

The individual must be free of HIV and hepatitis B and C infections,

hypertension, diabetes,etc

The blood group and the Rh status of the individual must be

determined and placed on record.

6. Sourcing of Donors and Surrogate Mothers:

Semen banks, ART clinic, or suitable independent

Organization

Encourage donation through appropriate advertisement

Maintain information about donors and surrogate mothers.

The organizations charge the couple for providing donor or

a surrogate.

7. Preservation, Utilization & Destruction of Embryos:

Couples must give specific consent to storage and use of their embryos by

other couples or for research

Research on embryo shall be restricted to the first fourteen days.

No commercial transaction will be allowed for the use of embryos for

research.

ICMR guidelines on Surrogacy

1. A child born through surrogacy must be adopted by the biological

parents unless they can establish through DNA fingerprinting.

2. Surrogacy by ART allowed only for patients , physically or medically

impossible to carry a baby to term.

3. Payments to surrogate mothers should cover all genuine expenses

associated with the pregnancy.

Documentary evidence of the financial arrangement for surrogacy must be

available.

The ART centre should not be involved in this monetary aspect.

4. Advertisements regarding surrogacy should not be made by the ART

clinic.

5. A surrogate should not be over 45 years of age.

6 . A relative, a known person , as well as a person unknown to the couple

may act as a surrogate mother for the couple.

7 . A surrogate mother must be tested for HIV and shown to be sero-

negative just before embryo transfer. provide a written certificate that ;

(a) h/o iv drugs use.

(b) not undergone blood transfusion.

(c) she and her husband (to the best of her/his knowledge) has

had no extramarital relationship in the last six months.

8. No woman may act as a surrogate more then thrice in her lifetime.

Present Indian scenario

1. Litigation against doctors :doctors can face few litigations like-

a. Not taking proper informed consent: After duly counselling the couple

/semen donor, an informed and written consent should be taken from both

spouses as well as donor.

b. Following the birth of a defective child: To avoid this, the donor's

chromosomes must be thoroughly screened for possible genetic defect.

2. Legitimacy - The child born by ART is considered legitimate with all the

rights of parentage, support and inheritance, provided he is born during

lawful consent of both the spouses.

A child can be given status of legitimacy also by adoption.

In a case, on the wife's petition for divorce and custody of the child,

• Child belong to mother alone.

• Husband had no rights or interest in the child.

• Child is illegitimate.

3. Inheritance of property:

• Child is illegitimate, if born out of AID.

• It cannot inherit the property of his father.

• Any attempt to conceal this fact by registering the husband, as the father

amounts to perjury.

4. Consummation of marriage:

• Conception of the wife by AI (AIH or AID) does not amount to

consummation of marriage.

• If no successful sexual act due to the impotency of husband.

• The decree of nullity may still be granted in favour of the wife or his wilful

refusal to consummate the marriage.

• The child will be illegitimate.

5. Rights of an unmarried woman to AID:

• There is no legal bar on an unmarried woman going for AID.

• A child born to a single woman through AID would be deemed to be

legitimate.

6. Ground for divorce and judicial separation:

• AI is not a ground for nullity of marriage and divorce since sterility is not a

ground.

• If AI is due to impotence of husband, it becomes the ground.

• AID without husbands consent can be a ground for divorce and judicial

separation.

7. Maintenance and custody of child: Under Hindu Adoption and

Maintenance Act 1956 the maintenance of the dependents is the

responsibility of the parents, whether legitimate or illegitimate, till the son

remains minor and daughter is unmarried.

8. Insemination after the death of the husband:

• When semen of the husband is cryo-preserved by various methods and the

women is inseminated after death of the husband.

• Posthumous child is said to be legitimate because the semen is of husband.

• Complexity arises since conception is not during the continuance of marriage.

9. Relation between AIH / AID child with subsequent Natural / Adopted

child of same family:

• If the child is born of natural course after the birth of the child through AI.

• The status will remain same for AI child but the natural child born will

remain legitimate.

10. Charge of Adultery:

• AID does not amount to adultery, even if done without the consent of

husband.

• For adultery to be committed both parties should be physically present and

engage in sexual act.

• AI not equivalent to sexual intercourse.

• For the charge of adultery to be proven,

sexual intercourse took place with another person's wife.

No consent or connivance from another man was granted.

11. Incestuous relationship: There is high risk of such relationship between

naturally born child and child born out of AID of the same parent.

Challenging Ethical Issues

A. Individual moral constraints on trying for reproduction “at any cost.

• Sex selection,

• screening for defect,

• Selective abortion ,

• Surrogate motherhood,

• Cloning,

B. Baby factory sells newborns like in Warsaw , Poland of Rs 11,000. It is

home to 37 young surrogate mothers. They say, they are offering services

since 1.5 million couple in Poland are being childless and they need more

peoples.

C. Posthumous Artificial insemination :due to availability of

semen banking, problems in inheritance rights of a child, born

after the death of genetic father.

D. Dehumanizing aspects of procedures : Moral status of the

Left-over Embryos, Egg, Sperm, and the Fertilized Egg stored

for a married woman who subsequently died.

E .Japanese surrogate baby Manjhi case :in a gestational

carrier was paid to carry the child to maturity in her womb and

was usually resorted to by couples to complete their dream of

being parents.

German couple: is striving hard for the citizenship of their twin

surrogate baby, born in India

F .An Israeli gay couple categorical has dislike for Section

377 of the Indian law that makes homosexuality a criminal

offence, but they like the `desi' regulation that allowed them to

hire a surrogate mother to deliver their child here. " Israel

doesn't allow same-sex couples to adopt or have a surrogate

mother.

First Gay couple to have a baby thru surrogate in

India

• Homosexual ManLesbians Single Partner

Right to have babies ???Bearing or Rearing ???Legal & Moral Status ???Production or Reproduction ???

Changing Society – Changing Concept

Why Surrogacy in India?

Indian surrogates very popular b/o-

• Easy availability

• Low cost

• Non demanding

• Indian clinics are becoming more

competitive

in pricing and retention and hiring of

surrogates.

THANKS