It was fifteen years ago that I sat listening to a lecture about the hazards of multiple pregnancy and how IVF had increased multiples so drastically in the preceding ten years. What a depressing thought. I loved helping women conceive. I was living my dream, practicing the infertility and IVF I had learned ten years earlier at the Jones Institute with Howard and Georgeanna Jones themselves as well as Zev Rosenwaks and other masters of the IVF craft.
I had seen quadruplets created first hand as a result of our IVF efforts. But, that was a necessary side effect of transferring a sufficient number of embryos to offer a patient a reasonable chance for a successful transfer. IVF was very inefficient back then and our pregnancy rate even in 1995 with transferring 3-4 embryos was at best 40%.
The sobering truth is that multiple pregnancies — even with ‘just’ twins — are sometimes dangerous to the health and well-being of mother and babies let alone the triplets that were still occurring in 7-10% of the pregnancies at the time.
Since then, thanks to dedicated research to fine-tune IVF, much has been learned about both clinical practice and laboratory technique. IVF is no longer experimental and is currently much more efficient so that the live birth rate for women under 35 years of age at East Coast Fertility is greater than 60% per retrieval.
One of the most important recent developments — single embryo transfer, or SET — is being consistently backed up by study after study as the optimal IVF method for patients with a good prognosis.
The SET Program
The safest pregnancy with the greatest chances for an optimal outcome — a healthy baby — is a singleton pregnancy. In 2007, East Coast Fertility started leading the field of reproductive medicine by establishing our own SET Program.
Confidence in our high quality embryology laboratory and immensely successful embryo cryopreservation program has afforded ECF the ability to limit the number of embryos transferred, essentially eliminating the risk of triplets or more.
We analyzed our success with elective single embryo transfer and compared it to our success with elective double embryo transfer since the opening of our lab in 2005.
Fresh eSET was less likely to result in pregnancy than eDET 39/75=52% vs. 342/561=61% though this difference was not significant statistically. When frozen embryo transfer pregnancies were added this difference was 64% vs. 68.3%. There were no multiples in the eSET group but a 27.8% twin rate in the eDET group with 2 cases of triplets. So to encourage patients with good prognosis to utilize SET, we offer the following incentive:
For the cost of an IVF cycle, SET Program patients will receive free cryopreservation of their embryos, free storage and free frozen embryo transfers until they have a baby. This represents a savings of up to over $12,000. It also ensures a much better chance of a healthy baby.
Is SET for you?
Each patient’s case is considered individually. Each factor impacting conception and pregnancy is taken into account, such as; the age of a patient, embryo quality, the number of prior failed IVF cycles and embryo quality. Single embryo transfer is appropriate in certain situations where the likelihood of a multiple pregnancy is high, including; women younger than 35 years, women who conceived with first IVF cycle, women with concerns about multiple gestation and donor egg recipients.
Single Embryo Transfer is revolutionizing the practice of reproductive medicine, and the team at East Coast Fertility is committed to their collective pledge to lead the way in creating safe, healthy pregnancies.

The case of a mix-up of frozen embryos in a Michigan IVF program in Feb. 2009 yet again became a media splash with the affected couple appearing on ABC News to promote their new book, “Misconceptions”.  The couple who already had a set of twins as a result of a successful IVF recounts a story about their experience including the fact that the frozen embryos were mistakenly transferred into the wrong woman.  This woman carried the pregnancy and after delivery handed the baby back to his biological parents.  Reports of the mix-up have triggered calls from a few to make IVF illegal.

Mixing up gametes and embryos is tragic and society must do everything humanly possible to prevent such a mix up except disallow the practice of IVF.  As with other societal advances, accidents have rarely and unfortunately happened in the field of IVF but, weighed against the benefit of all the babies who otherwise would never have been born, we should strive to improve the safety of IVF, not eliminate it.

Many of the greatest advances have had tragic results, unintended accidents that should have been avoided. Usually, they are the result of human error often preventable with the institution of carefully designed safeguards with a system of checks and balances.

Significant risk, including that of injury or death, is part of nearly everything we do in life today. The construction industry has always been plagued with accidental deaths. Not a bridge or a great high rise has been completed without misfortune. Do we stop construction? No, we ensure that all possible regulations that could protect those involved are in place and followed as strictly as possible to prevent further accidents.

Nuclear power is controversial because of the fear of accidents. Despite past accidents at Chernobyl and Three Mile Island, nuclear power plants continue to be constructed throughout the world because it is perceived that the possible benefits of this alternate source of energy outweighs the concerns for the risks.

Cardiac bypass surgery and other surgeries save lives and relieve suffering but, occasionally, patients intended to benefit are hurt or even killed accidentally. Rules and regulations are instituted to avoid problems such as performing the wrong operation on the wrong patient, using the wrong medication, operating on the wrong limb. Yet situations rarely occur, usually because of a human slip. Rules are broken and mistakes result.  When they do hospitals review the procedures and protocols and insure a sufficient system is in place to catch errors before they have an effect on patient care.

Just as we have safeguards in the operating room, we have them in place for identifying gametes and embryos with checks and balances that should prevent a mix-up such as the one in this case.

In the operating room, patients are identified while they are awake by the embryologist, nurse, physician and anesthesiologist by full name and birth date. As soon as the ovaries are aspirated, the eggs are identified and put in dishes with the patient’s full name and birth date on them. When the dishes are changed to replace the media, again matching names are put on the new dishes with a unique case number. A partner’s sperm specimen is labeled by him and processed in tubes labeled to match the partner’s name and the corresponding patient’s name and the case number. This is doubly checked with the patient’s record which will also reflect the unique case number. It is reviewed by two embryologists for accuracy prior to fertilization. Finally, when the embryo is loaded in a catheter for transfer, the identity of the dish from the embryo is checked by the physician, embryologist, nurse and the patient herself prior to the transfer being performed.

Every attempt is made to confirm the identity of the gametes and embryos throughout the IVF process prior to transfer. In 25 years of practicing IVF, my program has not mixed up gametes or embryos.

There are approximately 1 million babies born through IVF and only a few rare mix ups reported.

Perhaps we don’t hear about every mix up. I’d estimate that between 1/50,000 and 1/100,000 pregnancies from IVF have occurred with some mix up in the embryo or gamete. When it occurs, it is tragic and requires the attention of our field and a refocus on those checks and balances we have in place to prevent such mishaps.

I work hard and I pray that we do everything possible so that this never happens again. The FDA regulates gamete donation. The New York State Department of Health regulates our labs and our operating rooms. These checks and balances are in place and are included in the monitoring performed by these agencies.

Perhaps, if the other states required as strict a monitoring to ensure their clinics and doctors are adhering to the necessary safeguards as well then the mix-ups would not occur.

Successful IVF is dependent on many factors.  The quality of the egg and embryo, the placement of the embryo into the uterus and the environment surrounding implantation are all paramount to the ultimate goal of creating a pregnancy that leads to a live baby.

Typically, patients present with their own gametes so the genetics and pregnancy potential of the eggs and sperm is usually predetermined when patients first present to an IVF program.  As a specialist in REI and IVF, I have dedicated my career to optimizing those other factors that we may influence.

In the late 1990’s I recorded data on all my embryo transfers including distance the catheter tip was placed into the uterine cavity, number of cells and grade of the embryos, difficulty of the transfer, use of tenaculum etc.  I presented my results at the ASRM in 2000 that highlighted the two step transfer to the middle of the uterine cavity and replaced the tenaculum with a cervical suture when needed and this radically improved pregnancy rates.

The uterine environment has been optimized through screening for anatomic issues in the uterine cavity with a hydrosonogram to identify polyps, fibroids and scar tissue that may impede implantation.  Hormonally, we have supplemented patient’s cycles with progesterone through both vaginal and parenteral (intramuscular) administration as well as estrogen that we monitor closely after embryo transfer and make adjustments when deemed helpful.

The greatest improvement in pregnancy rates for the past several years however has been due to a Culture Revolution in IVF that is the media environment bathing and feeding the embryos.  All these advances have had a great impact on IVF success rates to the point that 50% of retrievals will result in a pregnancy.  Unfortunately, older patients and some younger ones have yet to share in this success.

Many IVF programs have reintroduced the concept of utilizing a co-culture medium to improve the quality and implantation of embryos. Co-culture is a procedure whereby “helper” cells are grown along with the developing embryo. Today, the most popular cell lines include endometrial cells (from the endometrium, or uterine lining) and cumulus cells from women’s ovaries.  Both cell lines are derived from the patient, thereby eliminating any concerns regarding transmission of viruses. Endometrial cells are much more difficult to obtain and process, while cumulus cells are routinely removed along with the oocytes during IVF retrieval.

Cumulus cells play an important role in the maturation and development of oocytes.  After ovulation cumulus cells normally produce a chemical called Hyaluronan.   Hyaluronan is secreted by many cells of the body and is involved in regulating cell adhesion, growth and development. Recent evidence has shown that Hyaluronan is found normally in the uterus at the time of implantation.

Co-culture of cumulus cells provides an opportunity to detoxify the embryo’s culture medium that the embryos are growing in and produce growth factors important for cell development.  This may explain why some human embryos can experience improved development with the use of co-culture.

Preparation of co-culture cells starts with separation of the cumulus cells from the oocytes after aspiration of the follicles. These sheets of cells are washed thoroughly and then placed in a solution that permits the sheets to separate into individual cells.  The cells are then washed again and transferred to a culture dish with medium and incubated overnight. During this time individual cells will attach to the culture dish and create junctions between adjoining cells. This communication is important for normal development. The following morning, cells are washed again and all normally fertilized oocytes (embryos) are added to the dish. Embryos are grown with the cumulus cells for a period of three days to achieve maximum benefit.

Performing co-culture of embryos has improved implantation and pregnancy rates above and beyond those seen with the IVF advances previously described. More importantly, it promises to offer advantages for those patients whose previous IVF cycles were unsuccessful.

Pre-embryo genetic screening (PGS) was developed to help weed out embryos containing inherited metabolic disorders and genetic abnormalities prior to implantation. It was thought that PGS could be used to minimize the risk of miscarriage and perhaps even increase live birth rates in older women IVF undergoing .

We have thus far been disappointed in our results obtained using the FISH technique, the procedure performed for PGS for the past decade and a half. But an alternative new technology that was recently developed makes me very excited about PGS once again: Array Comparative Genomic Hybridization (aCGH).

ACGH is a technique actually applied to detect deficiencies and excesses of genetic material in the chromosomes. DNA from a test sample and a normal reference sample are labeled using colored fluorophores that hybridize to several thousand probes. These probes are created from most of the known genes of the genome and placed on a glass slide.

The differential color of the test compared to the normal sample DNA reflects the amount of DNA in the test specimen. It can pick up monosomies, trisomies or significant deletions on an embryo’s chromosomes.

The first baby born from this procedure was in September 2009 to a 41-year old woman. When aCGH is performed on a Blastocyst biopsy, it is effective in screening out mosaicism (mixed cell lines in the same organism). ACGH is 20 percent more sensitive than the best FISH assays with an error rate of two to four percent. Fifty percent of the embryos tested were normal with pregnancy rates exceeding Blast transfers without aCGH screening.

So, who could benefit from using this new technology?

1. Patients with repeat miscarriages can eliminate up to 90 percent of their miscarriages.

2. Older patients who naturally have a higher percentage of genetically abnormal embryos may now screen for and only transfer their normal embryos.

3. Patients who want to maximize their success with a single embryo transfer.

4. Patients who have experienced repeat implantation failure can be screened for genetically abnormal embryos.

This technology is available for about the same cost as the FISH procedure yet, since it is performed on a Blastocyst, it is safer with less effect on the integrity of the embryo and without significant risk of wrongly identifying abnormal embryos. A concern with FISH is that embryos identified as abnormal can actually result in a normal fetus. This risk is practically eliminated with aCGH and is another reason making it more successful.

I expect PGS will now become a commonly used addition to standard IVF to promote more successful single embryo transfer, improve success in older patients, eliminate miscarriages and treat patients with repeat implantation failure.

We are approaching a new era in IVF. Brace yourselves for a thrilling ride into IVF’s future.

Fertility is dependent upon so many things!

We must have healthy gametes (eggs and sperm) capable of fertilizing and implanting in a uterus with a normal endometrial lining unimpeded by any uterine or endometrial pathology. The sperm need be in sufficient number and capable of swimming up through a cervix which is not inflamed and provides a mucous medium that promotes sperm motility. The eggs need to ovulate and be picked up by normal healthy fimbriated ends (finger like projections) of the fallopian tubes. The tubes need to be covered with normal micro hairs called cilia that help transport the egg one third of the way down the tube where one of the sperm will fertilize it.

The united egg and sperm (the “conceptus”) then needs to undergo cell division, growth and development as it traverses the tube and makes its way to the uterine cavity by the embryo’s fifth day of life at which point it is a blastocyst. The blastocyst hatches out of its shell (“zona pellucidum”) and implants into the endometrial lining requiring adequate blood flow.

And you wonder why getting pregnant is so hard?

All too often patients, in some groups as many as 30% of women, are told that they have fibroids that may be contributing to their infertility. Fibroids or leiomyomata are non malignant smooth muscle tumors of the uterus. They can vary in number, size and location in the uterus including; the outside facing the pelvic cavity (subserosal), the inside facing the uterine cavity (submucosal) and in between inside the uterine wall (intramural). Fortunately, most fibroids have minimal or no effect on fertility and may be ignored.

The subserosal myoma will rarely cause fertility issues. If it were distorting the tubo- ovarian anatomy so that eggs could not get picked up by the fimbria then it can cause infertility. Otherwise, the subserosal fibroid does not cause problems conceiving.

Occasionally, an intramural myoma may obstruct adequate blood flow to the endometrial lining. The likelihood of this being significant increases with the number and size of the fibroids. The more space occupied by the fibroids, the greater the likelihood of intruding on blood vessels traveling to the endometrium. Diminished blood flow to the uterine lining can prevent implantation or increase the risk of miscarriage. Surgery may be recommended when it is feared that the number and size of fibroids is great enough to have such an impact.
However, it is the submucosal myoma, inside the uterine cavity, that can irritate the endometrium and have the greatest effect on the implanting embryo.

To determine if your fertility is being hindered by these growths you may have a hydrosonogram. A hydrosonogram is a procedure where your doctor or a radiologist injects water through your cervix while performing a transvaginal ultrasound of your uterus. On the ultrasound, the water shows up as black against a white endometrial border. A defect in the smooth edges of the uterine cavity caused by an endometrial polyp or fibroid may be easily seen.

Submucosal as well as intramural myomata can also cause abnormal vaginal bleeding and occasionally cramping. Intramural myomata will usually cause heavy but regular menses that can create fairly severe anemias. Submucosal myomata can cause bleeding throughout the cycle.

Though these submucosal fibroids are almost always benign they need to be removed to allow implantation. A submucosal myoma may be removed by hysteroscopy through cutting, chopping or vaporizing the tissue. A hysteroscopy is performed vaginally, while a patient is asleep under anesthesia. A scope is placed through the cervix into the uterus in order to look inside the uterine cavity. This procedure can be performed as an outpatient in an ambulatory or office based surgery unit. The risk of bleeding, infection or injury to the uterus or pelvic organs is small.

Resection of the submucosal myoma can be difficult especially when the fibroid is large and can sometimes take longer than is safe to be performed in a single procedure. It is not uncommon that when the fibroid is large, it will take multiple procedures in order to remove the fibroid in its entirety. It will be necessary to repeat the hydrosonogram after the fibroid resection to make sure the cavity is satisfactory for implantation.

The good news is, when no other causes of infertility are found, removal of a submucosal fibroid is often successful in allowing conception to occur naturally or at least with assisted reproduction.

Those of you with secondary infertility need to know that you are not alone in feeling this way. My patients all express this alienation which exacerbates the depressing effects of infertility universally experienced among those affected. You have as much a right to fertility care as anyone else as well as the respect and care.

There are some unique characteristics to patients with secondary infertility that are worth discussion. Those of you who have had a caesarian section, ectopic pregnancy or abdominal surgery are more likely to have a tubal factor causing your infertility. Scar tissue can form that can obstruct, or displace a fallopian tube making it more difficult for the tube to pick up an ovulating egg or the fertilized egg to make it to the uterus.

Borderline sperm counts and endometriosis typically make it more difficult to conceive so that it is not unusual that it took longer than expected to conceive the first time and now you are not experiencing any success at all.

We perform a semen analysis and hysterosalpingogram and consider the potential benefit of laparoscopic investigation. Alternatively, if the semen analysis is not too bad and the HSG is normal, patients may benefit from insemination with hormonal stimulation. Otherwise, in vitro fertilization either with minimal or full stimulation will offer significantly superior success rates.

Facing secondary infertility may be as difficult emotionally as infertility for those without prior pregnancies. However, treatment options are available that are highly successful in delivering you the family of your dreams.

Although traditional full stimulation in vitro fertilization (IVF) procedures produce better pregnancy rates, minimal stimulation IVF (MS-IVF) induces ovarian follicle and egg development with less hormonal stimulation. As a result, patients going through minimal stimulation IVF incur less expense (thousands of dollars less) from meds in addition to the savings from less required monitoring and labwork. Currently, the fee for MS-IVF/MicroIVF is $3900.

Another benefit to MS-IVF is that a woman is not subjected to the high dose of gonadotropin drug stimulation eliminating the risk of hyperstimulation syndrome. It is also a lower risk to developing a multiple pregnancy and therefore results in safer pregnancies more likely to result in a live, healthy baby.

Although we get our highest pregnancy rates in young patients with lots of follicles like those with PCOS (polycystic ovarian syndrome), MS- IVF may be especially cost effective for older patients who do not respond to gonadotropin stimulation with very many follicles and eggs. We sometimes get as many eggs from a MS-IVF stimulation as a full stimulation in this group.

For patients who do not have coverage for intrauterine insemination (IUI), MS-IVF is a more cost effective, more successful, lower cost alternative and should therefore be considered as a first line of therapy before IUI especially when compared to gonadotropin IUI treatment.

If MS-IVF has all these advantages then why don’t all IVF programs offer it? The reason may be related to the fact that MS-IVF cases are counted the same as any IVF case in statistical reporting of pregnancy rates. Since success with a full stimulation is still on the average about twice that of MS-IVF, performing MS-IVFs will lower a program’s reported success rate. This is a difficult obstacle to overcome as many patients will comparison shop prior to selecting an IVF program.

For us, it is the welfare of our patients that is our concern. It is our goal to deliver the safest and most cost effective treatment to our patients that will offer our patients their best chance of building their family. We wish to make IVF accessible and safe to all those in need.

Sometimes my patients who have difficulty conceiving their second child feel like second class citizens in the infertility world.  Unlike their infertile peers without a child they perceive that friends, family and even their doctor’s offices do not have the same sympathy and concern for them as they observe others without a child receive.  I have had patients express guilt and anger in addition to the routine sadness often associated with the inability to conceive.

Those of you with secondary infertility need to know that you are not alone in feeling this way.  My patients all express this alienation which exacerbates the depressing effects of infertility universally experienced among those affected.  You have as much a right to fertility care as anyone else as well as the respect and care.

There are some unique characteristics to patients with secondary infertility that are worth discussion.  Those of you who have had a caesarian section, ectopic pregnancy or abdominal surgery are more likely to have a tubal factor causing your infertility.  Scar tissue can form that can obstruct, or displace a fallopian tube making it more difficult for the tube to pick up an ovulating egg or the fertilized egg to make it to the uterus.

Borderline sperm counts and endometriosis typically make it more difficult to conceive so that it is not unusual that it took longer than expected to conceive the first time and now you are not experiencing any success at all.

We perform a semen analysis and hysterosalpingogram and consider the potential benefit of laparoscopic investigation.  Alternatively, if the semen analysis is not too bad and the HSG is normal, patients may benefit from insemination with hormonal stimulation.  Otherwise, in vitro fertilization either with minimal or full stimulation will offer significantly superior success rates.

Facing secondary infertility may be as difficult emotionally as infertility for those without prior pregnancies.  However, treatment options are available that are highly successful in delivering you the family of your dreams.

You have that dreaded infertility diagnosis, “Over 40 With High FSH Levels.” And there’s no cure or magic herb that will turn back the hands of time. You’re desperate so you are willing to try it all anyway, including acupuncture and some internet recommendations such as DHEA (dehydroepiendosterone).

You hear that you can lower your FSH with DHEA or estrogen. The fact is, however, elevated FSH levels do not cause a problem with conceiving. They are merely a marker of diminishing ovarian reserve, a depletion of ovarian follicles and eggs that, combined with increasing age, means you have very few genetically normal eggs available in your ovaries to achieve a healthy child.

Reproductive endocrinologists typically counsel “Over 40 With High FSH Levels” patients that their chance of successfully achieving a live birth using their own eggs is small and that by using a donated egg from a young, fertile woman they can increase their odds of giving birth to greater than 70 percent per donation. Unfortunately, this comes as a shocking disappointment to most women. It’s often a reason for them to drop out of a doctor’s practice or even quit trying to conceive.

So what do you do when faced with this situation? Your answer needs to be individualized, based on your emotional and financial resources, your motivation and your comfort with using a donated egg.

At our clinic, we try to come up with a strategy with our patients that includes counseling to begin the discussion about donor eggs, as opposed to trying with less chance for successful outcome using a patient’s own eggs, or stopping therapy completely and adopting or living child-free.

Perhaps you will choose a low tech option such as insemination with or without hormonal therapy. Sometimes, the plan will be to blast ahead with the big guns using IVF with full stimulation or with less medication and cost using MicroIVF or Minimal Stimulation IVF. Some patients respond better to different stimulations such as sensitizing with estrace or even DHEA prior to stimulation, using a lupron flare or even using clomid in combination with gonadotropins. Unfortunately, it is hard to predict what will be the optimal stimulation for you until we give it a shot.

The bottom line? There’s no right or wrong choice for you. Remember, a family can look many different ways and still be a healthy, loving unit. Your physician, nurses and counselors are available to assist you and support you with whatever decision you make.

Perhaps it’s unfortunate that fertility doctors have to be so concerned about their patient’s pocket books unlike other fields of medicine that are usually covered by some measure of insurance.  But in the case of infertility with only a handful of states having some kind of mandated coverage – not everybody in the United States -  mandate or no mandate for infertility  -even has health insurance!  Many fertility patients are in some form or another “cash pay” patients.  One of the most popular places that patients visit when they go to any fertility clinic’s website is the finance page.  This is simply a fact of life.

For this reason I have developed many programs that will create access to fertility care for as many people as possible.  But here is the catch! One program does not fit all. These are simply not over sized tee shirts – each of these programs represent a certain course of  medical care – and each individual and couple needs the assistance of a caring doctor to help them choose the right program that will fit their own particular medical history.  In addition to the NY State DOH Grant Program and our own East Coast Fertility Grant Program, we have the Micro-IVF Program, The Money Back Guarantee Program,  and The Single Embryo Transfer Program.  The most effective treatment and the most efficient is always a full stimulation IVF. However, if someone has insurance coverage for IUI and meds but not IVF then they may prefer to do IUI. If they do not have coverage for IUI either then it may be more cost effective to do the Micro-IVF Program or minimal stimulation IVF at 2-3 x the success of IUI with less risk than gonadotropin IUI and less cost per pregnancy. Yet at a price of $3900 it may be more attractive than a full stimulated IVF. There is also The Single Embryo Transfer Program where we reward patients transferring one embryo at a time by making their cryo, embryo storage and unlimited frozen embryo transfers for free.  Others prefer the insurance of The Money Back Guarantee Program where patients are offered six IVF retrievals and frozen embryo transfers for a fixed fee that is refunded if they do not result in a live birth.   In order to inform patients about our success and programs that make IVF more available to them we offer free consultations.

In today’s world of fertility care – a good doctor will help a patient find not only the right treatment but how to access that care.  In order to do that – a doctor may have to do what some may think is unseemly – and that is to talk about money.