Consent for In Vitro Fertilization



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Consent for In Vitro Fertilization


 

 
 


______________________________________________________ ______________________________________

Print Patient’s Full Legal Name Unique Identifier (Social Security No.)

(DOB, if no Social Security No.)

 

 



 

______________________________________________________ ______________________________________



Print Partner’s Full Legal Name Unique Identifier (Social Security No.)

(DOB, if no Social Security No.)

 

 



 

 


 

 

 

 



In Vitro Fertilization

Process, Risk, and Consent

In Vitro Fertilization (IVF) has become an established treatment for many forms of infertility.  The main goal of IVF is to allow a patient the opportunity to become pregnant using her own eggs or donor eggs and sperm from her partner or from a donor. This is an elective procedure designed to result in the patient’s pregnancy when other treatments have failed or are not appropriate.


This consent reviews the IVF process from start to finish, including the risks that this treatment might pose to you and your offspring.  While best efforts have been made to disclose all known risks, there may be risks of IVF that are not yet clarified or even suspected at the time of this writing.

 

An IVF cycle typically includes the following steps or procedures:



  • Medications to grow multiple eggs

  • Retrieval of eggs from the ovary or ovaries

  • Insemination of eggs with sperm        

  • Culture of any resulting fertilized eggs (embryos)

  • Placement ("transfer") of one or more embryo(s) into the uterus

  • Support of the uterine lining with hormones to permit and sustain pregnancy

In certain cases, these additional procedures can be employed:

  • Intracytoplasmic sperm injection (ICSI) to increase the chance for fertilization

  • Assisted hatching of embryos to potentially increase the chance of embryo attachment ("implantation")

  • Cryopreservation (freezing) of eggs or embryos

Note: At various points in this document, rates are given which reflect what are believed to be U.S. national averages for those employing IVF treatments.  These include items such as pregnancy rates, Cesarean delivery rates, and preterm delivery rates.  These rates are not meant to indicate the rates of these outcomes within individual practices offering IVF, and are not to be understood as such.  Individual practices may have higher or lower pregnancy and delivery rates than these national averages, and also higher or lower risks for certain complications.  It is appropriate to ask the practice about their specific rates.

 

Also note that while this information is believed to be up to date at the time of publication (2013), newer reports may not yet be incorporated into this document. 

IVF Procedures



Medications for IVF Treatment

 

The success of IVF largely depends on growing multiple eggs at once



Injections of the natural hormones FSH and/or LH (gonadotropins) are used for this purpose

Additional medications are used to prevent premature ovulation

An overly vigorous ovarian response can occur, or conversely an inadequate response
Medications may include the following (not a complete list):


  • Gonadotropins, or injectable “fertility drugs (Follistim®, Gonal-F®, Bravelle®, Menopur®):  These natural hormones stimulate the ovary in hopes of inducing the simultaneous growth of several oocytes (eggs) over the span of 8 or more days.  All injectable fertility drugs have FSH (follicle stimulating hormone), a hormone that will stimulate the growth of your ovarian follicles (which contain the eggs).  Some of them also contain LH (luteinizing hormone) or LH-like activity. LH is a hormone that may work with FSH to increase the production of estrogen and growth of the follicles.  Low-dose hCG (human chorionic gonadotropin) can be used in lieu of LH. These medications are given by subcutaneous or intramuscular injection.  Proper dosage of these drugs and the timing of egg recovery require monitoring of the ovarian response, usually by way of blood tests and ultrasound examinations during the ovarian stimulation.

As with all injectable medications, bruising, redness, swelling, or discomfort can occur at the injection site.  Rarely, there can be there an allergic reaction to these drugs.  The intent of giving these medications is to mature multiple follicles, and many women experience some bloating and minor discomfort as the follicles grow and the ovaries become temporarily enlarged.  Up to 2.0 % of women will develop Ovarian Hyperstimulation Syndrome (OHSS) [see full discussion of OHSS in the Risks to Women section that follows].  Other risks and side effects of gonadotropins include, but are not limited to: fatigue, headaches, weight gain, mood swings, nausea, and clots in blood vessels.
Even with pre-treatment attempts to assess response, and even more so with abnormal pre-treatment evaluations of ovarian reserve, the stimulation may result in very few follicles developing; the end result may be few or no eggs obtained at egg retrieval or even cancellation of the treatment cycle prior to egg retrieval.
Concerns have been raised that the risk of ovarian cancer may increase with the use of fertility drugs, but recent studies have not confirmed this. A major risk factor for ovarian cancer is infertility per se, and early reports may have falsely attributed the risk resulting from infertility to the use of medications to overcome it (see 2.b.2 for further discussion).

 


  • GnRH-agonists (leuprolide acetate) (Lupron®):  This medication is taken by injection. There are two forms of the medication: A short acting medication requiring daily injections and a long-acting preparation lasting for 1-3 months.  The primary role of this medication is to prevent a premature LH surge, which could result in the release of eggs before they are ready to be retrieved. Since GnRH-agonists initially cause a release of FSH and LH from the pituitary, they can also be used to start the growth of the follicles or initiate the final stages of egg maturation.  Though leuprolide acetate is an FDA (U.S. Food and Drug Administration) approved medication, it has not been approved for use in IVF, although it has routinely been used in this way for more than 20 years.  Potential side effects usually experienced with long-term use include, but are not limited to: hot flashes, vaginal dryness, bone loss, nausea, vomiting, skin reactions at the injection site, fluid retention, muscle aches, headaches, and depression.  No long term or serious side effects are known. Since GnRH-a are oftentimes administered after ovulation, it is possible that they will be taken early in pregnancy. The safest course of action is to use a barrier method of contraception (condoms) the month you will be starting the GnRH-a. GnRH-a has not been associated with any fetal malformations however you should discontinue use of the GnRH-a immediately if pregnancy is confirmed.




  • GnRH-antagonists (ganirelix acetate or cetrorelix acetate) (Ganirelix®, Cetrotide®):  These are another class of medications used to prevent premature ovulation.  They tend to be used for short periods of time in the late stages of ovarian stimulation.  The potential side effects include, but are not limited to: abdominal pain, headaches, skin reaction at the injection site, and nausea.

 

  • Human chorionic gonadotropin (hCG) (Profasi®, Novarel®, Pregnyl®, Ovidrel®):  hCG is a natural hormone used in IVF to induce the eggs to become mature and fertilizable.  The timing of this medication is critical to retrieve mature eggs.  Potential side effects include, but are not limited to: breast tenderness, bloating, and pelvic discomfort.

 

  • Progesterone, and in some cases, estradiolProgesterone and estradiol are hormones normally produced by the ovaries after ovulation.  After egg retrieval in some women, the ovaries will not produce adequate amounts of these hormones for long enough to fully support a pregnancy.  Accordingly, supplemental progesterone, and in some cases estradiol, are given to ensure adequate hormonal support of the uterine lining.  Progesterone is usually given by injection or by the vaginal route (Endometrin®, Crinone®, Prochieve®, Prometrium®, or pharmacist-compounded suppositories) after egg retrieval.  Progesterone is often continued for some weeks after a pregnancy has been confirmed.  Progesterone has not been associated with an increase in fetal abnormalities. Side effects of progesterone include depression, sleepiness, allergic reaction, and if given by intra-muscular injection, includes the additional risk of infection or pain at the injection site. Estradiol, if given, can be by oral, trans-dermal, intramuscular, or vaginal administration. Side effects of estradiol include nausea, irritation at the application site if given by the trans-dermal route and the risk of blood clots or stroke.

                     

  • Oral contraceptive pills Some treatment protocols include oral contraceptive pills to be taken for 2 to 4 weeks before gonadotropin injections are started in order to suppress hormone production or to schedule a cycle. Side effects include unscheduled bleeding, headache, breast tenderness, nausea, swelling and the risk of blood clots or, very rarely, stroke.            




  • Other medications:  Antibiotics may be given for a short time during the treatment cycle to reduce the risk of infection associated with egg retrieval or embryo transfer.  Antibiotic use may be associated with vaginal yeast infection, nausea, vomiting, diarrhea, rashes, sensitivity to the sun, and allergic reactions.  Anti-anxiety medications or muscle relaxants may be recommended prior to the embryo transfer; the most common side effect is drowsiness.   Other medications such as steroids, heparin, low molecular weight heparin or aspirin may also be included in the treatment protocol.  

Transvaginal Oocyte (Egg) Retrieval
Eggs are removed from the ovary with a needle under ultrasound guidance

Anesthesia is provided to make this comfortable

Complications are rare

Oocyte retrieval is the removal of eggs from the ovary. A transvaginal ultrasound probe is used to visualize the ovaries and the egg-containing follicles within the ovaries.  A long needle, which can be seen on ultrasound, can be guided into each follicle and the contents aspirated.  The aspirated material includes follicular fluid, oocytes (eggs) and granulosa (egg-supporting) cells. Rarely the ovaries are not accessible by the transvaginal route and laparoscopy or trans-abdominal retrieval is necessary. These procedures and risks will be discussed with you by your doctor if applicable.  Anesthesia is generally used to reduce, if not eliminate, discomfort. Risks of egg retrieval include:


Infection:  Bacteria normally present in the vagina may be inadvertently transferred into the abdominal cavity by the needle.  These bacteria may cause an infection of the uterus, fallopian tubes, ovaries or other intra-abdominal organs.  The estimated incidence of infection after egg retrieval is less than 0.1%.  Treatment of infections could require the use of oral or intravenous antibiotics.  Severe infections occasionally require surgery to remove infected tissue.  Infections can have a negative impact on future fertility. Prophylactic antibiotics are sometimes used before the egg retrieval procedure to reduce the risk of pelvic or abdominal infection in patients at higher risk of this complication. Despite the use of antibiotics, there is no way to eliminate this risk completely.
Bleeding:  The needle passes through the vaginal wall and into the ovary to obtain the eggs.  Both of these structures contain blood vessels.  In addition, there are other blood vessels nearby.  Small amounts of blood loss are common during egg retrievals.  The incidence of major bleeding problems has been estimated to be less than 0.1%.  Major bleeding may require surgical repair and possibly loss of the ovary.  The need for blood transfusion is rare.  (Although very rare, review of the world experience with IVF indicates that unrecognized bleeding has lead to death.)
Trauma:  Despite the use of ultrasound guidance, it is possible to damage other intra-abdominal organs during the egg retrieval.  Previous reports in the medical literature have noted damage to the bowel, appendix, bladder, ureters, and ovary.  Damage to internal organs may result in the need for additional treatment such as surgery for repair or removal of the damaged organ.  However, the risk of such trauma is very low.
Anesthesia: The use of anesthesia during the egg retrieval can produce unintended complications such as an allergic reaction, low blood pressure, nausea or vomiting and in rare cases, death. 
Failure: It is possible that the aspiration will fail to obtain any eggs or the eggs may be abnormal or of poor quality and otherwise fail to produce a viable pregnancy. 
In vitro fertilization and embryo culture

Sperm and eggs are placed together in specialized conditions (culture media, controlled temperature, humidity and light) to achieve fertilization.

Culture medium is designed to permit normal fertilization and early embryo development, but the content of the medium is not standardized.

Embryo development in the lab helps distinguish embryos with more potential from those with less or none.


After eggs are retrieved, they are transferred to the embryology laboratory where they are kept in conditions that support their needs and growth.  The eggs are placed in small dishes or tubes containing "culture medium," which is special fluid developed to support development of the eggs and embryos made to resemble that found in the fallopian tube or uterus.  The dishes containing the eggs are then placed into incubators, which control the temperature and atmospheric gasses the eggs and embryos experience.

A few hours after eggs are retrieved, sperm are placed in the culture medium with the eggs, or individual sperm are injected into each mature egg in a technique called Intracytoplasmic Sperm Injection (ICSI) (see below).  The eggs are then returned to the incubator, where they remain to develop.  Periodically over the next few days, the dishes are inspected so the development of the embryos can be assessed.

The following day after eggs have been inseminated or injected with a single sperm (ICSI), they are examined for signs that the process of fertilization is underway.  At this stage, normal development is evident by the still single cell having 2 nuclei; this stage is called a zygote or a 2PN embryo.  Two days after insemination or ICSI, normal embryos have divided into about 4 cells.  Three days after insemination or ICSI, normally developing embryos contain about 8 cells.  Five days after insemination or ICSI, normally developing embryos have developed to the blastocyst stage, which is typified by an embryo that now has 80 or more cells, an inner fluid-filled cavity, and a small cluster of cells called the inner cell mass.

It is important to note that since many eggs and embryos are abnormal, it is expected that not all eggs will fertilize and not all embryos will divide at a normal rate.  The chance that a developing embryo will produce a pregnancy is related to many factors including whether its development in the lab is normal, but this correlation is not perfect.   This means that not all embryos developing at the normal rate are in fact also genetically normal, and not all poorly developing embryos are genetically abnormal.  Nonetheless, their visual appearance is the most common and useful guide in the selection of the best embryo(s) for transfer.





In spite of reasonable precautions, any of the following may occur in the lab that would prevent the establishment of a pregnancy:

 

  • Fertilization of the egg(s) may fail to occur.

  • An egg may be fertilized abnormally resulting in an abnormal number of chromosomes in the embryo; these abnormal embryos will not be transferred.

  • The fertilized eggs may degenerate before dividing into embryos, or adequate embryonic development may fail to occur.

  • Bacterial contamination or a laboratory accident may result in loss or damage to some or all of the eggs or embryos.

  • Laboratory equipment may fail, and/or extended power losses can occur which could lead to the destruction of eggs, sperm and embryos.

  • Other unforeseen circumstances may prevent any step of the procedure to be performed or prevent the establishment of a pregnancy.

  • Hurricanes, floods, or other 'acts of God' (including bombings or other terrorist acts) could destroy the laboratory or its contents, including any sperm, eggs, or embryos being stored there.

 

Quality control in the lab is extremely important. Sometimes immature or unfertilized eggs, sperm or abnormal embryos (abnormally fertilized eggs or embryos whose lack of development indicates they are not of sufficient quality to be transferred) that would normally be discarded can be used for quality control. This material may be used for quality control purposes before being discarded in accordance with normal laboratory procedures and applicable laws. None of this material will be utilized to establish a pregnancy or a cell line.


Embryo transfer

After a few days of development, the best appearing embryos are selected for transfer

The number chosen influences the pregnancy rate and the multiple pregnancy rate

A woman’s age and the appearance of the developing embryo have the greatest influences on pregnancy outcome

Embryos are placed in the uterine cavity with a thin tube

Excess embryos of sufficient quality that are not transferred can be frozen





After a few days of development, one or more embryos are selected for transfer to the uterine cavity. Embryos are placed in the uterine cavity with a thin tube (catheter). Ultrasound guidance may be used to help guide the catheter or confirm placement through the cervix and into the uterine cavity. Although the possibility of a complication from the embryo transfer is very rare, risks include infection and loss of, or damage to the embryos.
The number of embryos transferred influences the pregnancy rate and the multiple pregnancy rate. The age of the woman and the appearance of the developing embryo have the greatest influence on pregnancy outcome and the chance for multiple pregnancy.  While it is possible, it is unusual to develop more fetuses than the number of embryos transferred.  It is critical to discuss with your doctor the number to be transferred before the transfer is done.
In an effort to help curtail the problem of multiple pregnancies (see multiple pregnancies), national guidelines published in 2013 recommend limits on the number of embryos to transfer (see Tables below). These limits should not be viewed as a recommendation on the number of embryos to transfer. These limits differ depending on the developmental stage of the embryos and the quality of the embryos and take into account the patient’s personal history. 

Recommended limits on the number of embryos to transfer





Age < 35

Age 35-37

Age 38-40

Age >40

Embryos













--favorable

1 or 2

2

3

5

--not favorable

2

3

4

5

Blastocysts













--favorable

1

2

3

3

--not favorable

2

2

3

3

In some cases, there will be additional embryos remaining in the lab after the transfer is completed.  Depending on their developmental normalcy, it may be possible to freeze them for later use. (See section 2.c. for an in-depth discussion of embryo cryopreservation).

   Hormonal support of the uterine lining

Successful attachment of embryo(s) to the uterine lining depends on adequate hormonal support

Progesterone, given by the intramuscular or vaginal route, is routinely given for this purpose
Successful attachment of embryos to the uterine lining (endometrium) depends on adequate hormonal support of the lining.  The critical hormones in this support are progesterone and estradiol.  Normally, the ovary makes sufficient amounts of both hormones.   However, in IVF cycles, this support is not always adequate.  Therefore, progesterone is routinely given, and in some cases, estradiol is also prescribed.  Progesterone is given by the intramuscular or vaginal route.  Estradiol is given by the oral, vaginal, trans-dermal or intramuscular route.  The duration of this support is from 2 to 10 weeks.

Additional Elements

Intracytoplasmic Sperm Injection (ICSI)

ICSI is used to increase the chance of fertilization when fertilization rates are anticipated to be lower than normal

Overall success rates with ICSI are slightly lower than for conventional insemination

An increased risk of genetic defects in offspring is reported

ICSI will not improve oocyte defects

The use of ICSI provides an effective treatment for male factor infertility. The negative effects of abnormal semen characteristics and sperm quality on fertilization can be overcome with ICSI if viable sperm are available because the technique bypasses the shell around the egg (zona pellucida) and the egg membrane (oolemma) to deliver the sperm directly into the egg.  ICSI involves the direct injection of a single sperm into the interior of an egg using an extremely thin glass needle.  ICSI allows couples with male factor infertility to achieve fertilization and live birth rates similar to those achieved with in vitro fertilization (IVF) using conventional methods of fertilization in men with normal sperm counts.  ICSI can be performed even in men with no sperm in the ejaculate if sperm can be successfully collected from the epididymis or the testis.

ICSI is associated with a slightly higher risk of birth defects. Whether this association is due to the ICSI procedure itself or to inherent sperm defects, however, has not been determined. The impact of ICSI on the intellectual and motor development of children has also been controversial, but recent studies have not detected any differences in the development of children born after ICSI, conventional IVF, or natural conception. 

Certain genetic abnormalities have been shown to increase in IVF offspring. The prevalence of sex chromosome (X and Y) abnormalities in children conceived via ICSI is higher than observed in the general IVF population, but the difference between the two groups is small (0.8% to 1.0% in ICSI offspring vs. 0.2% in the general IVF population). Translocations (a re-arrangement of chromosomes that can cause miscarriage) may be more common in ICSI offspring (0.36%) than in the general population (0.07%). Although these differences might result from the ICSI procedure itself, men with abnormal semen analyses are more likely themselves to have chromosome abnormalities and may produce sperm with abnormal chromosomes. These abnormalities could be passed to their offspring.



Some men with extremely low or absent sperm counts have small deletions on their Y chromosome. When viable sperm can be obtained to fertilize eggs with ICSI, sperm containing a Y chromosomal microdeletion may result in male offspring who also carry the microdeletion and may be infertile. A Y chromosome microdeletion can often, but not always, be detected by a blood test.
Men who are infertile because of congenital bilateral absence of the vas deferens (CBAVD) are affected with a mild form of cystic fibrosis (CF). When sperm aspiration and ICSI results in conception, the CF gene will be passed on to the offspring.  Men with CBAVD and their partners should be tested for CF gene mutations prior to treatment. However, some CF mutations may not be detected by current testing, so that some parents who test negative for CF mutations could still have affected children.
Assisted Hatching 

Assisted Hatching involves making a hole in the outer shell (zona pellucida) that surrounds the embryo

Hatching may make it easier for embryos to escape from the shell that surrounds them.
The cells that make up the early embryo are enclosed within a flexible membrane (shell) called the zona pellucida.  During normal development, a portion of this membrane dissolves, allowing the embryonic cells to escape or “hatch" out of the shell. Only upon hatching can the embryonic cells implant within the wall of the uterus to form a pregnancy.

Assisted hatching is the laboratory technique in which an embryologist makes an artificial opening in the shell of the embryo. The hatching is usually performed on the day of transfer, prior to loading the embryo into the transfer catheter. The opening can be made by mechanical means (slicing with a needle or burning the shell with a laser) or chemical means by dissolving a small hole in the shell with a dilute acid solution.

 

Some programs have incorporated artificial or “assisted hatching" into their treatment protocols because they believe it improves implantation rates, and ultimately, live birth rates although definitive evidence of this is lacking. 



 

Risks that may be associated with assisted hatching include damage to the embryo resulting in loss of embryonic cells, or destruction or death of the embryo.  Artificial manipulation of the zygote may increase the rates of monozygotic (identical) twinning which are significantly more complicated pregnancies. There may be other risks not yet known. 


   Cryopreservation    

Freezing of eggs and embryos can provide additional chances for pregnancy.

Frozen eggs and embryos do not always survive the process of freezing and thawing. 

Ethical and legal dilemmas can arise when couples separate or divorce, especially for embryos; disposition agreements are essential.

It is the responsibility of each couple with frozen eggs and / or embryos to remain in contact with the clinic on an annual basis.
Freezing (or “cryopreservation”) of eggs or embryos is a common procedure.  Since multiple eggs (oocytes) are often produced during ovarian stimulation, on occasion there are more embryos available than are considered appropriate for transfer to the uterus. Such embryos can be frozen for future use. Alternatively, some eggs can be frozen before being exposed to sperm. Both strategies save the expense and inconvenience of stimulation to obtain additional eggs in the future.  Furthermore, the availability of cryopreservation permits patients to transfer fewer embryos during a fresh cycle, reducing the risk of high-order multiple gestations (triplets or greater).  Other possible reasons for cryopreservation of embryos include freezing all embryos in the initial cycle to prevent severe ovarian hyperstimulation syndrome (OHSS), or if a couple were concerned that their future fertility potential might be reduced due to necessary medical treatment (e.g., cancer therapy or surgery). The pregnancy success rates for cryopreserved embryos transferred into the human uterus can vary from practice to practice.  Overall pregnancy rates at the national level with frozen embryos are lower than with fresh embryos.  This, at least in part, results from the routine selection of the best-looking embryos for fresh transfer, reserving the 'second-best' for freezing.  There is some evidence that pregnancy rates are similar when there is no such selection.

 

Indications:



  • To reduce the risks of multiple gestation

  • To preserve fertility potential in the face of certain necessary medical procedures

  • To increase the chance of having one or more pregnancies from a single cycle of ovarian stimulation

  • To minimize the medical risk and cost to the patient by decreasing the number of stimulated cycles and egg retrievals

  • To temporarily delay pregnancy and decrease the risks of hyperstimulation (OHSS- see below) by freezing all embryos, when this risk is high.


Risks of cryopreservation: There are several techniques for embryo cryopreservation, and research is ongoing.  Traditional methods include “slow,” graduated freezing in a computerized setting, and “rapid” freezing methods, called “vitrification.”  Current techniques deliver a high percentage of viable eggs and embryos thawed after cryopreservation, but there can be no certainty that eggs and embryos will thaw normally, nor be viable enough to divide and eventually implant in the uterus.  Cryopreservation techniques could theoretically be injurious to the embryo.  Extensive animal data (through several generations), and limited human data, do not indicate any likelihood that children born of embryos that have been cryopreserved and thawed will experience greater risk of abnormalities than those born of fresh embryos.  However, until very large numbers of children have been born following freezing and thawing of embryos, it is not possible to be certain that the rate of abnormalities is no different from the normal rate.
If you choose to freeze eggs or embryos, you MUST complete and notarize the Disposition for Eggs or Disposition for Embryos statement before freezing. This statement outlines the choices you have with regard to the disposition of embryos in a variety of situations that may arise. You are free to submit a statement at a later time indicating different choices, provided you both agree in writing. It is also incumbent upon you to remain in touch with the clinic regarding your residence, and to pay for storage charges as they come due.



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