IVF / Frozen Embryo Transfer Clinical Contract

AGREEMENT FOR MEDICAL SERVICES
(In vitro Fertilization and Embryo Transfer Program)
The present Agreement for Medical Services (hereinafter referred to as “Agreement”) has been
concluded 20/10/2010(date/month(day)
between
(1) Neo-Est LTD clinic -------- Ltd. – registered in
represented by Dr Nana Kvernadze
(hereinafter referred as “Clinic”)
and
(2) Mrs. (--------------------) (hereinafter referred to as the “Female-Partner”) – born ----------(--------------------- issued by --------------and
Mr. (--------------------- ) (hereinafter referred to as the “Male-Partner”) – born --------------, (Lisboa PRT), Passport N---------------, issued by -------------------------(hereinafter referred together to as the Female-Partner and the “Male-Partner” and individually
as the “Patient”).
(Hereinafter each of them is referred to as the “Party” and together as the “Parties”)
ARTICLE 1. SUBJECT OF THE AGREEMENT
1.1.
1.2.
1.3.
In accordance with the terms of the present Agreement and on its basis the Patient shall
order and Clinic shall undertake liabilities to render medical services to the Patient.
In accordance with the present Agreement the medical services to be rendered to the
Patient involve:
 In vitro fertilization or intracytoplasmic sperm injection
 Embryo transfer
 Oocyte/sperm cell/embryo freezing
 Frozen embryo transfer
Separate stages of the medical services and other detailed information are given in
Appendix No. 1 to the Agreement (“Consent Form”)
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Female-Partner
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Male-Partner
ARTICLE 2. PATIENTS CONSENT
2.1. In accordance with the acting legislation and the internal policy of Clinic the medical
services specified in the present Agreement shall be rendered only on condition, if the Patient
(Female-Partner and Male-Partner):
 Get acquainted with the “Consent Form” (“Consent Form”) given in Appendix 1 to the
Agreement;
 Is given (if necessary) additional information and explanation;
 Verifies his/her full consent to the terms and provisions of the present Agreement by
signing the Agreement.
2.2. The Patient shall declare and verify that he/she had enough time for examination and
analysis of the “Consent Form”, received sufficient explanation, could get additional
consultations in connection with the above (including other medical consultants) was competent
when learning and signing voluntarily the present Agreement and the Consent Form without any
force, threat, deception or mistake made by Clinic or any other third party.
ARTICLE 3. PAYMENT
3.1. All payments related to medical services will be done by Healthcare Agency International
New Life Georgia.
ARTICLE 4. RELEASE FROM RESPONSIBILYTY
4.1. The patient shall realize that Clinic does not guarantee the results of the medical services
specified in the present Agreement, or there is no guarantee of successful realization of the
relevant procedures and occurrence of pregnancy. At the same time, the Patient shall realize and
recognize that he/she was comprehensively and clearly informed about the risks and discomfort
that may result from the medical services specified in the Agreement.
4.2. Proceeding from the above paragraph 4.1., the Patient shall declare his/her consent and
shall recognize that he/she voluntarily agree to receive the medical services together with
relevant risk and possible discomfort. Accordingly, the patient shall agree that Clinic, its medical
personnel, managers, distributors, employees, representatives and other agents bear no
responsibility and accordingly the Patient will not demand any material or other kind of
compensation for damages (including the return of the amounts specified in Article 3) if:
4.2.1. The medical service does not give any result;
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Female-Partner
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Male-Partner
4.2.2. The medical service results in side-effects and/or discomfort which are specified in
the present Agreement and/or in the Consent Form;
4.2.3. Interruption and/or suspension of medical services takes place on the grounds
specified in the present Agreement and/or in the Consent Form.
4.3. To exclude any suspensions, the provisions for the release from responsibility are invalid if
the damage is caused by strong negligence, deliberated actions or lack of conscientiousness of
Clinic, its medical personnel, managers, employees, representatives and/or other agents.
4.4. The provisions concerning the release from responsibility remain valid after termination or
cancellation of the present Agreement.
ARTICLE 5. COMING INTO EFFECT AND OPERATION
OF THE AGREEMENT
5.1. With allowance for the provisions given in paragraph 5.2., the present Agreement enters
into force from the date of its signing by the Parties and is valid till complete fulfillment by the
Parties of their obligations.
5.2. In spite of the provisions given in Article 5.1., the Agreement will come into force from the
date of its signing only if all conditions given below are satisfied:
5.2.1. The Patient (Female-Patient and Male-Patient) will sign the Consent Form and the
above will be verified by witnesses of the Patient (Female-Patient and Male-Patient);
5.2.2. The payment specified in the provisions of Article 3 will be effected by the Patient or
his/her representative..
If any of 5.2.1. – 5.2.2. subparagraphs is not satisfied by the moment of signing the Agreement, in
the absence of other agreement between the Parties, the present Agreement will come into force
after fulfilling the conditions envisaged in these subparagraphs.
5.3. Untimely termination of the Agreement shall be allowed on the following grounds:
5.3.1. By mutual agreement of the Parties.
5.3.2. At request of the Patient.
5.3.3. By decision of the doctor in charge of the Patient (if and when the doctor in charge
deems it necessary or reasonable to stop/interrupt medical services proceeding from other
interests of the Patient)
5.3.4. In other cases envisaged by the present Agreement and/or by the corresponding
Appendices and/or by other agreements related, thereto and/or specified by Law.
5.4. In case of untimely termination of the Agreement:
5.4.1. The Patient shall immediately fulfill all financial commitments (including the
payments specified in Article 3 and any other indebtednesses) to Clinic.
5.4.2. Clinic is released from the undertaken liabilities to the Patient and the Patient does
not demand from Clinic to return the paid amounts.
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Female-Partner
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Male-Partner
ARTICLE 6. CONFIDENTIALITY
6.1. With allowance for the paragraphs 6.2. and 6.3. of the Article 6 Clinic shall keep
confidentiality on the Patient’s case report, diagnosis and treatment results during operation of
the present Agreement and after its termination.
6.2. Divulging of the confidential information is allowed if:
6.2.1. The patient’s consent is obtained.
6.2.2. Non-divulging of the information is dangerous for the life and/or of the third party
(whose personality is known).
6.2.3. When using the information on the Patient in educational or scientific purposes the
data about a patient are represented in a way that makes personal identification
impossible.
6.2.4. The information is or will become available for public independent of requirements
of Law.
6.3. Signing of the present Agreement by the Patients means his/her (their) consent to divulging
of the confidential related to the state of the Patient’s health by Clinic to other participating in
the medical service.
ARTICLE 7. REGULATING LEGISLATION AND SETTLMENT OF DISPUTES
7.1. The present Agreement is regulated by the Legislation of Georgia.
7.2. All disputes between the Parties will be settled by means of negotiations. If the Parties
within 30 (thirty) days from the day of sending a notification on the dispute settlement by one
Party to the other Party do not come to an agreement, the Parties, to settle the dispute, apply to a
corresponding Court or state body envisaged by the Legislation. By agreement between the
Parties, the above-mentioned dispute can be considered at the Georgian Arbitration Court.
ARTICLE 8. REGULATION LEGISLATION AND SETTLMENT OF DISPUTES
8.1. All amendments and addenda to the present agreement are valid only on condition of being
made in a written form and signed by the representatives of the Parties.
8.2. Any right granted to Clinic by the Patient is added to the rights given by the present
Agreement and by the Law.
8.3. Invalidity of any provision of the present agreement does not mean invalidity of the whole
Agreement. Instead of the invalid provision, the provision which achieves better the goal of the
present Agreement (including that of the invalid provision) is used.
8.4. The Appendices to the present Agreement shall form its integral part.
8.5. Additional agreement and other agreement concluded on the basis of the present Agreement
are given a priority in connection with the matters for regulation of which similar or other
agreements have been concluded.
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Female-Partner
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Male-Partner
8.6. Notification and other communications envisaged by the Agreement have to be handed over
or posted by a registered mail to the addresses given below.
8.7. The present Agreement is drawn up in two equally valid copies one of which is given to
Clinic and the other to the Patient (Female-Partner and Male-Partner).
Signatures of the parties:
CLINIC
PATIENT
______________
____________________
(Female-Partner)
____________________
Address:57 Ikalto/ Bakhtrioni Str.Tbilisi
Georgia 0171
Tel:+ 995 32 36 75 01
Fax:+ 995 32 36 75 01
Contact person: Nana Kvernadze
(Male-Partner)
Address:
Tel:
Fax:
Contact person:
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Female-Partner
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Male-Partner
Appendix No. 1
CONSENT FORM
IN VITRO FERTILIZATION AND EMBRYO TRANSFER PROGRAM
We/I Female-Partner and Male-Partner cannot give birth to a child because of nonfunctional
fallopian tubes or the absence of tubes, sperm pathology or because of other diseases that
cannot be treated by other methods. We decided to undergo a course of treatment by the
method of in vitro fertilization and embryo transfer during which fertilization of ovum by sperm
takes place outside the organism in laboratory conditions and by signing the present Consent
Form we express our consent to all procedures to be used by Clinic which are necessary and/or
expedient for the treatment that will be chosen by our (my) doctor in charge in Neo-Est Ltd. at
his/her discretion.
1. CONSENT TO THE USE OF NECESSARY PROCEDURES FOR
IN VITRO FERTILIZATION AND EMBRYO TRANSFER
Below all steps required for this treatment are given.
We/I agree that the following stages be used
FOR FEMALE-PARTNER
1. In my ovaries for oocyte maturation (ovary stimulation) the medicines will be used. For
stimulation of my ovaries: gonadotropin releasing hormone agonists and antagonists, human
menopause gonadotropins, recombinant gonadotropins and human chorionic gonadotropin will
be used.
2. During monitoring of the growth of ovarian follicle, I will need to do blood tests (in the
morning) for hormonal investigation.
3. I will need ultrasound to establish the growth of follicle.
4. I will be called to Clinic for ovum aspiration.
5. Under the control of ultrasound follicles will be aspirated from the ovaries through the vagina
to obtain matured eggs.
6. I recognize that for oocyte pick-up anesthesia or intravenous analgesia which is a general
method to remove pain will be needed.
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Female-Partner
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Male-Partner
7. The oocytes will be cultured with sperm into a special solution for fertilization. The fertilized
oocyte is cultured into the solution required for the embryo growth.
8. After several divisions of oocytes, in case normally developed embryos have been obtained,
they will be transferred through the cervix to the uterine cavity (the number of transferred
embryos will be agreed beforehand).
9. In two weeks after the transfer, a blood test will be done to establish pregnancy.
FOR MALE-PARTNER
On the day of ovary aspiration I will give my sperm obtained via masturbation. The sperm will
be treated and prepared for ovum insemination.
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We understand that from oocytes several embryos can be obtained and after the transfer
multiple pregnancy may develop. We were warned about the risks concerning multiple
pregnancy, such as: fetal reduction, premature delivery, necessity of cesarean section, etc.
We recognize that in any following cases pregnancy may not develop:
a. Ovarian stimulation is cancelled due to failed response.
b. Oocytes or sperm cells are not available for IVF or ICSI.
c. Oocytes may not be perfect.
d. Fertilization may not occur.
e. Fertilization may occur, but embryo division will not take place.
f. The embryo may not develop normally.
g. Embryo implantation may not take place.
We recognize that in case of pregnancy there is a danger of interruption of pregnancy
(spontaneous abortion). (In the general population the frequency of spontaneous
abortion is 20%).
We recognize that during the pregnancy fetus congenital defects develop whose
frequency after in vitro fertilization does not exceed the defect development frequency in
the general population (3-5%)
We recognize that for the development pregnancy ultrasound and hormone monitoring is
required.
We recognize that a chance of pregnancy occurrence is 20-50% and IVF success depends
on the causes of childlessness and the age of the Female-Partner.
We recognize that there is no guarantee for successful realization of the procedure and
pregnancy occurrence.
We recognize that the treatment may be accompanied by the following risks and
discomfort:
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Female-Partner
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Male-Partner
1. After using stimulation medication the ovarian hyper-stimulation may develop,
caused by the growth of the more than one follicle. The hyper-stimulation syndrome
causes dehydration, accumulation of liquid in the abdominal cavity and lungs, blood
coagulation disturbances and will need hospitalization. The risk of this syndrome is
equal to 1-15%.
2. Follicle aspiration may be accompanied by:
a. Bleeding, infection, damage of abdominal cavity organs (urinary bladder, intestine,
and/or blood vessels) which sometimes needs surgical intervention.
b. Discomfort after the procedure.
c. Risks connected with anesthesia or analgesia.
3. After the transfer of the embryo into the uterus cavity the following complications
may be observed:
a. Discomfort, infection, and bleeding.
b. With the transfer of more than one embryo development of multiple pregnancy
and the related risks.
c. Pregnancy treatment is connected with psychological stress (the couple will need
the support of the family doctor, friends and colleagues).
We recognize that IVF/ICSI and embryo transfer cycle may be interrupted at any stage in the
case of corresponding medical indications, which is decided by the team of the Clinic. We
recognize that in the case of risk we are to agree with the physician’s decision.
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2. CONSENT TO SPERM/OOSYTE/EMBRYO MANIPULATIONS
We/I agree that the Clinic’s in vitro fertilization team use our sperm, oocytes and
embryos for micromanipulations accompanying ovarian aspiration. This is necessary for
increasing the chance of child birth after in vitro fertilization.
Usually, fertilization occurs by penetration of one spermatozoa into the egg. The fertilized
egg undergoes several divisions and an embryo develops. The embryo releases from the
coverage and attaches itself to the uterus (implantation occurs).
Micromanipulation methods were developed for injection of one spermatozoa into the
egg when the spermatozoa is not able to penetrate into the egg.
Intracytoplasmic sperm injection (ICSI) means sperm injection into the cytoplasm of an
egg.
Intracytoplasmic sperm injection (ICSI) is performed by decision of the Clinic’s in vitro
department team in the case when the treatment of the couple using this procedure will
be more successful, e.g. in those couples whose previous IVF treatment was ineffective.
The Male-Partner has poor-quality sperm.
There is a potential risk of sperm, egg or embryo damage; 5-10% of eggs are damaged
during ICSI. The IVF team does its best to avoid the eggs’ damage.
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Female-Partner
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Male-Partner
3. CONSENT TO FREEZING AND TRANSFER OF THE EMBRYO
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We realize that more eggs can be fertilized than is recommended for the transfer into
the uterus cavity. We wish extra embryos to be frozen and used only with your consent.
We realize that in the case of embryo freezing there is no guarantee that embryo will
survive the freezing. In this case there is also no guarantee for pregnancy occurrence.
The frequency of genetic defects born from the frozen and thawed embryos is the same as
in the population.
The transfer of the frozen and thawed embryo into the uterus is possible when the
endometrium is ready for implantation.
We realize that to prepare the endometrium for this procedure, hormonal treatment and
monitoring is necessary which involves: blood tests and ultrasound. Thawing and
transfer of the frozen embryo occurs only when all monitoring data are within the normal
limits.
We realize that we are to pay timely for embryo storage in Clinic. In case of nonfulfillment of this duty the fertilized embryos will be destroyed.
For in vitro fertilization and embryo transfer, micromanipulations and embryo and
sperm cell freezing procedures and the related possible risks have been explained to us
by the Clinic’s Team.
We/I understood perfectly the explanations made at Clinic.
We had an opportunity to ask any questions to which full and clear answers were
given.
We were also given the comprehensive information on alternative methods of
treatment and the related risks and effects as well as on possible results of refusing
to undergo the treatment.
We can ask Clinic’s employees or any responsible person any question by the
telephone number: …….
We realize that in vitro fertilization and embryo transfer are our request and with
our consent.
We have also been given a comprehensive explanation on financial and social
matters related to the treatment, including the amount and the order of payment.
We understand that we can stop the procedure at any time (in accordance with the
provisions of the Agreement concluded with Clinic) and that this decision will have
no effect on any future medical service and treatment at Clinic.
Patients participating in donation and surrogate mother program (couple,
partners) are referred to us Patient (Couple, Partners) Customer.
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Female-Partner
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Male-Partner
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In case of any complication with a donor or a surrogate, related to ovary
stimulation, ovum aspiration, embryo transfer, developed pregnancy, I and my
Partner bear responsibility and financial expenses for treatment (possible risks
and discomfort are described in detail in the Consent Form).
Female-Partner (Patient-Customer)
Male-Partner (Patient-Customer)
Date:
Date
Tel:
Tel:
Head of IVF Department
Physician -----------
Date:
Date:
Tel:
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Female-Partner
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Male-Partner