Fertility evaluation and procedures

 

Fertility Evaluation

One of the most frequent concerns conveyed on this web site involves the thought by many that the infertility evaluation, carried out attempting to uncover the "cause" of an infertility problem, may have been incomplete or may have overlooked something.

There are many valid approaches to the work up of a couple who have been unsuccessful in their attempts to become pregnant. While the angle of the approach to a fertility problem may vary from physician to physician, and from Center to Center, it is generally felt by us that there are certain "basics" to be investigated in nearly every couple with an infertility condition. These baseline studies may be slightly modified based on the initial history of the couple involved, but in general, the items presented here are considered very important to us in the study of nearly all couples.

While reading this, it is important to remember that these are generalized protocols and the studies mentioned may not be applicable to every couple. These suggestions represent the protocols in effect at our Centers, and they are not meant to indicate a suggested treatment course. You should always attempt to obtain the most qualified medical help available and work together with your health care providers to obtain the highest quality opinions about your workup.

Summary of an Infertility Work up

At the Fertility Institutes, we ask new patients to complete a very detailed medical history questionnaire prior to presenting for their first appointment. These history forms are forwarded to patients in advance to allow them adequate time to complete the forms at home and to obtain the very detailed information asked for. We include questions related to the patient, details of the pregnancy of the patient's mother (both husband and wife), fertility histories of the patient, brothers, sisters and immediate family members. We question very closely about life styles and diet, history of "health food" ingestion, vitamin history, and any history of food supplement use (herbs, etc.). Questions about possible occupational exposures to hazardous environments or chemicals and high stress environments are included. Possible detrimental effects on fertility of all of the above have been reported. A sexual history is obtained and the correction of any misconceptions or misinformation is carried out and cleared up.

After a complete history has been obtained, we outline a detailed, intense diagnostic program to allow us to arrive at a rapid diagnosis of the underlying fertility problem. While many variations of the protocol are employed to account for items uncovered in the history, we always begin with baseline studies that, if not recently performed elsewhere, include the following:

• Vaginal and cervical viral and bacterial cultures. These are used to detect any possible adverse infections that may be interfering with conception.
• Semen analysis and semen cultures.
• Sperm penetration and sperm function studies (Hamster, etc.).
• Female gonadotropin and other pituitary hormone studies. These studies are performed on the third day of the menstrual cycle in order to allow comparison to fertile "control" subjects whose blood was evaluated on the same day 3. These studies also include thyroid function studies, and evaluations of the adrenal gland, ovaries, lactation hormones and the uterus.
• Hysterosalpingogram. This X-Ray examination is able to uncover many abnormalities in the lining and configuration of the uterus, as well as demonstrating the fallopian tubes and detecting any partial or complete blockage of the tubes. Scarring around the tubes and ovaries can often be detected as well.
• Midcycle testing for the "LH surge". The LH surge is the brain's signal to the ovaries ordering release of the mature egg. Our patients are asked to monitor their urine at home in anticipation of the LH surge that will occur just prior to ovulation. When the patient detects her LH surge, she is asked to have intercourse in the morning, and then is brought in later that day for several very important timed studies:
• Post-coital (after intercourse) examination; a small drop of cervical mucus is taken from the cervix and examined under the microscope for the presence of live, active sperm.
• Midcycle estradiol (E2) and ultrasound. The LH surge signals the bodies "satisfaction" with the status of the mature oocyte (egg). The accuracy of this "decision" by the body is tested by looking at the follicle that contains the egg with ultrasound, as well as by measuring the amount of estrogen (estradiol) that the granulosa cells that nurse the egg are producing. The uterine lining can be seen with ultrasound, and measured to assure that the lining has developed to an adequate degree to support a new pregnancy should one arrive. These are crucial studies and are often found to be abnormal in many patients with otherwise "normal" study results.
• Luteal phase Progesterone level. One week after ovulation, the "scar" left over after the egg releases from the ovary should be producing abundant quantities of Progesterone. Progesterone performs many crucial functions in the second half of the menstrual cycle. It signals the uterus that ovulation has occurred and prepares the uterus for implantation of the new conceptus, should it arrive. It adds vital hormonal support to the uterine lining, preventing premature breakthrough bleeding or "spotting" . Patients with abnormal Progesterone levels may actually conceive, but lose their early pregnancies before they ever know they were pregnant. This condition can usually be detected and corrected with careful monitoring.
• Endometrial Biopsy. A small fragment sampled from the lining of the uterus just before the end of a menstrual cycle can reveal important information about the response of the uterus to all of the hormonal signals that have occurred during the cycle. We ask a pathologist to evaluate the biopsy under the microscope, and to "date" the uterine lining to test for an appropriate response to the hormone signals delivered during the cycle. An "out of sync" uterine lining is a correctable condition that can cause major infertility problems if undetected or untreated.

All of the above represent a sampling of some of the initial studies that we obtain on nearly every patient. As results become available on each study, those results may lead to the need for additional studies. Each fertility problem should be approached as a unique challenge, and should be afforded a complete, highly detailed evaluation. Success rates rely upon the establishment of an accurate diagnosis. We feel that patients should always be provided their underlying diagnosis, and should use that information to assist them in their own evaluation of any proposed treatment plans.

 

Fertility Procedures

All services at the Fertility Institutes are offered on a seven day a week basis. The Fertility Institutes are registered with the American Society of Reproductive Medicine (the American Fertility Society). We maintain an active SART membership, and report all treatment outcome statistics to the Society. We were responsible for the first ICSI assisted birth in the Western United States and have continued to maintain state of the art treatment options for our patients at costs that remain highly affordable. Financing for many of our programs is available in many instances.

Procedures Offered

• Artificial Insemination: Intracervical, intrauterine, intraperitoneal
• Gradient Sperm Washing, Filtration and Improvement
• Testicular Sperm Aspiration (Extraction) MESA, PESA, TESA, Including for Failed Vasectomy Reversal
• Controlled Multiovulation (Fertility Drugs), Including the GnRH Infusion Pump for "Single Egg" Production
• Immature Oocyte Harvest
• Secure embryo cryopreservation (freezing & storage)
• Oocyte Micromanipulation: ICSI, Assisted Hatching, Preimplantation Genetic Diagnosis
• Immunology, Antibodies and Miscarriage Prevention

Artificial Insemination: Intracervical, intrauterine, intraperitoneal
These procedures are utilized to treat a variety of fertility conditions that may include poor cervical mucus production resulting from previous cervical surgery (freezing, cone biopsy, LEEP), cervical antibodies being produced against sperm, diminished sperm motility and donor sperm placement. Intraperitoneal insemination (IPI) has shown high pregnancy rates in some women who have failed to concieve with other forms of insemination and is always considered by us prior to moving on to more costly and invasive procedures. With IPI, treated sperm are injected by way of the vagina, directly into the pelvic cavity where eggs are released. A very small catheter is used to avoid discomfort.

Gradient Sperm Washing, Filtration and Improvement
Highly effective, inert density solutions are commonly used to prepare sperm for In Vitro Fertilization and related procedures with excellent success. Though more costly and time consuming than other methods for preparing sperm for artificial insemination, it is the method utilized in nearly all of our standard sperm preparations for artificial insemination. This method produces a purer sperm sample with increased motility and fertilizing capacity.

Testicular Sperm Aspiration (Extraction) MESA, PESA, TESA, Including for Failed Vasectomy Reversal
Our urologists, together with our Reproductive Endocrinologists are able to successfully aspirate or extract sperm directly from different areas of the testicle, and use this sperm to microinject (ICSI) a single sperm directly into the harvested eggs of the female. Using these methods, pregnancies and births are now possible with sperm from men who have had vasectomies, have had unsuccessful or failed vasectomy reversals, and in those men with an absence of the vas deferens, and those with extremely low sperm counts (less than 1 million), very poor motility (less than 2%) or, in some cases, even men with no sperm motility or no sperm seen in the ejaculate. We offer comprehensive descriptions of these procedures over the phone, and you are invited to call for more details. We also provide electroejaculation procedures for men with ejaculatory dysfunction resulting from a variety of causes including spinal cord injuries. All of our facilities provide full access for the disabled. MORE ON MESA, TESA, TESE, PESA

Controlled Multiovulation (Fertility Drugs), Including the GnRH Infusion Pump for "Single Egg" Production
We are one of the largest users of native (natural), pulsatile infusion GnRH for the production of single healthy eggs in women with hypothalamic amenorrhea who do not ovulate regularly. By employing very small, portable automated infusion pumps, very tiny doses of fertility medication can be administered in small pulses around the clock. This method more accurately simulates what occurs in a "natural" cycle, and largely avoids the chance of a multiple pregnancy resulting.

Immature Oocyte Harvest
The harvest and culture of immature oocytes is under active development by our program. We have yet to see significant encouraging results from programs carrying out this procedure. Our initial investigational efforts have shown promise but we will wait until further safety and outcome data become available prior to undertaking this procedure clinically. We update our Web site frequently and will report to you developments in the field. (Updated 4/98).

Secure embryo cryopreservation (freezing & storage)
Our entire fertility laboratory is licensed by all appropriate agencies. We hold a valid California Tissue Bank License assuring ongoing compliance with all safety, security and methodology requirements for the handling and cryopreservation of patient specimens. All Nevada State requirements have been met as well.

Oocyte Micromanipulation: ICSI, Assisted Hatching, Preimplantation Genetic Diagnosis
The Fertility Institutes perform highly successful micromanipulation procedures. We achieved the first successful ICSI derived pregnancy in the Western United States as well as the first multiple pregnancy from purely ICSI derived embryos. Our ICSI success has been extended to men with sperm counts far less than 1 million and to patients who had previously failed multiple earlier IVF attempts at other programs.



Immunology, Antibodies and Miscarriage Prevention
We offer complete couple tissue type compatability testing through our association with a leading immunology laboratory. We work closely with the country's leading immunology experts, and offer full laboratory testing that includes preparation for and administration of paternal leukocyte immmunization, aspirin/heparin/prednisone protocols as well as a variety of cutting edge methods to both improve pregnancy outcome associated with advanced fertility procedures, as well as to prevent pregnancy loss from occuring.

 

IVF Procedures

• GIFT, ZIFT, TET
• Low Cost IVF Alternatives: IPI, DOST
• Summary of the IVF Process

In Vitro Fertilization (IVF): GIFT, ZIFT, TET
We maintain our own outstanding IVF laboratories in Los Angeles and Las Vegas, as well as utilizing, in selected cases, additional leading IVF laboratories in Southern California and Nevada. We operate the only IVF progams in the Antelope Valley and in Jalisco, Mexico. Our combined success rates have remained in the top 20% of programs nationwide ever since our first case in 1981. You are urged to compare our price per cycle and for multi-cycle packages. We have always guaranteed to meet or beat any documented and substantiated price quote from any SART registered program in the Country.

Low Cost IVF Alternatives: IPI, DOST
Intraperitoneal insemination (IPI) and Direct Oocyte-Sperm Transfer (DOST) are two low cost, highly effective procedures popularized at our Centers. IPI involves the direct injection of Percoll washed and filtered sperm directly into the lower pelvis just as eggs are released into the same location from the ovaries that have been pre-stimulated with fertility medications. This is, in essence, a variant of the GIFT procedure, placing eggs and sperm directly in contact with each other in the presence of the fallopian tubes. This procedure requires at least one healthy fallopian tube and, in well selected patients, yields pregnancy rates approaching those of the GIFT procedure at 1/4 the cost of GIFT. Direct oocyte-sperm transfer (DOST) involves transvaginal retrieval of eggs from the stimulated ovary, just as in standard IVF. However, following retrieval, instead of inseminating the eggs with sperm and placing them into the incubator, the eggs are inseminated and transferred directly into the uterus nonsurgically two hours later. This allows the eggs to fertilize within the uterus, making it acceptable for women with damaged, nonfunctional or absent fallopian tubes, just as in IVF. Tremendous cost savings are achieved by eliminating the 2-3 day IVF laboratory culture charges. DOST success rates are quite acceptable, with procedure costs approximately half those of a standard IVF cycle.

Summary of the IVF Process

Phase	Purpose	Drugs and Procedures	Percent Reaching This Step
1. Ovarian stimulation and monitoring	To cause ovaries to produce many mature oocytes in a single cycle	GnRH (Lupron) analog injections hMG or FSH injections hCG injection, frequest blood tests, frequent ultrasound examinations	100 %
2. Egg collection	To collect oocytes before they are released from ovaries	Needle puncture(s) through vaginal wall into ovaries or laparoscopic surgery	92.5 %
3. Fertilization and embryo culture	To create viable embryos	Sperm preparation Fertilization Laboratory culture	90.0 %
4. Embryo transfer	To establish a pregnancy	Embryo evaluation in laboratory Determining number of embryos to transfer Insertion of catheter through cervix into uterus	77.8 % (nationwide data) Fertility Institutes: 92.5 %
5. Pregnancy	To gestate developing fetus(es)	Progesterone/other drugs* Fetal reduction* Prenatal diagnosis*	SART Summaries
6. Delivery	To deliver live infant(s)	Cesarean delivery*	SART Summaries

* Although these interventions are not necessarily used, they are more likely than in non-IVF pregnancies.

 

Reversal Procedures

Vasectomy Reversal
Our Centers are staffed by Board Certified Urologists that specialize in male infertilty. We provide classic microsurgical vasectomy reversal procedures, along with techniques such as MESA, TESA and PESA (see below) which include simple, through the anesthetised skin, needle aspiration of sperm, and methods to overcome failed vasectomy reversals. Cost for vasectomy reversal is approximately $ 6,400.00.

Tubal Ligation Reversal
We perform both laparoscopic and "open" microsurgical tubal reanastamosis. Success rates in selected cased approach 85%. These procedures are also offered by our Guadalajara based associates at facilities in Mexico at substantially lower hospital prices ($7,200 total cost), with no compromise in success.

Sex (Gender) Selection Employing PGD and Sperm Separation

The selection of gender has been a quest of couples for as far back as recorded history allows. Early drawings from prehistoric times suggest that sex selection efforts were being investigated by our earliest ancestors. Later history shows intense interest in sex selection by early Asian (Chinese), Egytptian and Greek cultures. This is followed by documented scientific efforts begining in the 1600's to sway the chances of achieving a pregnancy by a variety of methods. Research and work carried out in the 1980's and 90's have finally provided methods offering the chance of obtaining a desired pregnancy gender outcome that ranges from excellent to virtually GUARANTEED.

Scientific Understanding

It has been known for many years that the gender of a pregnancy is determined by the sex chromosome carried by the sperm. Sperm bearing an "X" chromosome, when united with the "X" from the female (females only produce "X") will result in an "XX" pregnancy that produces a female. If a sperm bearing a "Y" chromosome (men have both "X" and "Y" bearing sperm) unites with the "X" chromosome from the female, an "XY" pregnany will result that gives rise to a male offspring.

Armed with this knowledge, science has worked to allow for an accurate method of safely separating sperm to allow only those sperm capable of producing the desired gender to be exposed to the female egg (oocyte). While a variety of methods have been reported and studied, in reality, very few of these methods have withstood scientific scrutiny that "checks" the validity of claims made by those employing the procedure.

The Fertility Institutes have been performing gender selection procedures that are constantly checked and double checked employing the services of a Board Certified geneticist. In this manner, we maintain the upper hand in assisting couples achieve their desired outcome.

We currently offer two methods of sex selection. The first method provides virtually a 100% assurance (guarantee) that a resulting birth will be of the gender selected. The second method provides slightly lower success rates, but also costs much less.

Method 1 involves In Vitro Fertilization (IVF) using sperm that have been separated by our standard sex selection process. The resulting embryos are then analyzed with PGD to determine their absence of common genetic disorders "aneuploidy" as well as to determine their gender component. This method allows us to determine the sex of each embryo obtained with IVF prior to returning the embryo(s)to the mother-to-be. By assuring that only embryos of the chosen gender are placed in the uterus (womb), success in obtaining the desired outcome is virtually assured should pregnancy result. This is NOT a genetic "manipulation" or "engineering" procedure.

In the second method, manipulation of the sperm is carried out to increase the percentage of sperm of the chosen gender used for intrauterine insemination. This modality, in our hands, provides sperm separation success rates of greater than 80%.

Unlike many programs offering sex selection, we closely scrutinize our potential patients prior to allowing entrance into our program. This should be remembered by all couples considering undertaking this medical option. REMEMBER: Not every couple needs or qualifies for sex selection!

Imagine the following scenarios, which are taken from our clinical files:

Couple 1
Mr. & Mrs. Jones (names are fictitious) present to our offices with a request for gender selection. The couple reports having successfully conceived and delivered three healthy females. The last birth was three years ago. Mr. Jones has a strong family history of girls being born, with his only brother having produced two girls, and three cousins also having had a total of seven female and one male offspring. Mr. Jones underwent genetic analysis of the "sex ratio" (percentage of "X" and "Y" sperm) of his total sperm production. This very important study is carried out by a Certified cytogeneticist. His ejaculate was found to contain only 28% of the viable sperm seen carrying a "Y" (male producing) chromosome. His total sperm count was 42 million per ml. So, of the 42 million sperm, only 28% had the correct sex chromosome needed to produce a male. After separating his sperm for the desired gender, we would be left with a sperm count of only 12 million. This would not be enough to allow for a reasonable chance of the couple conceiving with simple sperm selection and insemination. Advised of the situation concerning their sperm sex ratio, the couple wisely elected to proceed with the IVF-PGD option. They were rewarded with a twin pregnancy that resulted in the birth of two healthy, male infants. While we exist to provide high quality medical services, we very strictly adhere to guidelines that have a history of providing excellent outcome results. While we cannot "guarantee" a desired outcome to anyone, we can now come as close to a guarantee as science allows. With the IVF-PGD option, success rates approach 100%. Couples in our program can feel comfortable that if they are accepted into the tretament course, they do have an excellent chance of achieving the desired outcome. Consider the next scenario:

Couple 2
This couple presented us with a history of having produced three boys over the past seven years. With very few female offspring in either of their families, they are interested in sex selection aimed at the production of a female. Total sperm count on the male was 88 million per ml. Sex ratio demonstrated 41% of his sperm to be "X" (female) producing. After our sperm separation, we obtained 34 million sex selected sperm per ml and the couple conceived a female pregnancy on their second attempt.

Sex Selection FAQs

Sex selection is a widely practiced procedure in the United States and world wide. Our Center's experience with sex selection as well as a thorough review of the literature allows us to offer the following information and answers to questions:

• Has sex selection produced a reasonable number of successes?
  YES! While success rates vary between programs, most programs employing standard sperm separation procedures report success rates in the 80-85 percent range. Success with IVF-PGD approaches 100% worldwide. Our program reports an 84-88% chance of achieving the desired gender outcome with sperm separation and a 99-100% assurance with IVF-PGD.
• Are fertility drugs used in sex selection procedures?
  Yes and No. Sex selection being carried out on normally fertile couples who have already produced one or more offspring and are using the sperm separation procedure do not normally require fertility drugs. Our sperm separation/sex selection procedures are offered, however, to couples needing and undertaking fertility treatment as well. In these cases, the drugs normally used for these fertility procedures are combined with the sex selection procedure. In the case of IVFD-PGD, fertility drugs are used consistent with our normal IVF procedures.
• How many babies have been born as a result of sex selection?
  Thousands of healthy babies have been born following sex selection procedures.
• Is there an increased risk of a birth defect after the sex selection procedure?
  No. Many studies have been carried out on artificial insemination procedures. These studies, looking at fresh, frozen, washed and isolated sperm show no increase in the occurence of birth defects when compared to natural conception. In the case of IVF-PGD, while new, there has thus far been noted no increased risk to the offspring. It should be remembered that PGD is new and is being studied closely. For this reason, we recommend it primarily to couples requiring gender selection for very compelling reasons.
• How is the sex selection procedure carried out?
  In method 1 (IVF-PGD), see our Web page related to "standard IVF". Following retrieval of the eggs with IVF. the eggs are inseminated in the laboratory with sperm that has been gender selected as in the "type 2" method below. These sperm are then used to fertilize the healthy eggs by the embryologist. After a few days growing in the incubator, the resulting embryos are gently biopsied to allow us to obtain a cell that may be used to determine the sex (gender) of each embryo. Once this information is available (usually within 24 hours), we can select only those embryos of the desired gender for implantation. Options are offered for the disposition of the remaining embryos that include the ability to cryopreserve the embryos or offer the embryos for embryo adoption to other couples in need of embryos. In method 2, using an ovulation predictor kit, patients with regular menstrual cycles are instructed to call our office when their test kit indicates ovulation is about to occur. A semen sample is produced for the visit and the sperm are separated in preparation for an artificial insemination. After a successful separation has been performed, a gentle artificial insemination procedure is carried out by placing the sex selected sperm into the body of the uterus, next to the fallopian tubes. This procedure is generally painless, and lasts just a few short moments. In some instances, a second insemination may be carried out the following day. Two weeks later, arrangements for a pregnancy test can be made. Sex selection is offered to couples from abroad. Due to the intricacies of the procedures, we only offer the IVF-PGD option to those that live distant to our laboratories. In spite of the higher cost for IVF-PGD, when travel expenses are calculated into the equation, IVF-PGD is a much more cost- effective option. Couples from afar are invited to call our offices for information on our assitnace packages for those traveling to us for treatment.
• Can frozen sperm be used for sex selection?
  Yes. Frozen sperm are subject to the same evaluation studies as fresh sperm to determine suitability for separation. If found to qualify, these sperm may be used for selection with both the type 1 and type 2 procedures.
• Can sex selection be performed with "regular" In Vitro Fertilization?
  Yes. We routinely offer type 2 sex selection options to couples undergoing In Vitro Fertilization for non male factor infertility reasons.