MicroSort®: FREQUENTLY ASKED QUESTIONS (FAQ)

Words or phrases underlined are linked/defined in the Glossary of Terms and italics are linked to other informational pages. For additional information, please contact MicroSort.

What is MicroSort?
MicroSort is a new scientific method, currently in clinical trial, that increases the chance of a couple having a child of a particular gender. MicroSort is used before conception to separate sperm into those that either primarily produce girls or those that primarily produce boys. For most couples, the sorted sperm sample is then used with simple intrauterine insemination (IUI) to achieve pregnancy. For couples who need additional assistance achieving pregnancy, MicroSort can be used with in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI).  Couples using MicroSort for the prevention of X-linked disorders may also consider using preimplantation genetic diagnosis (PGD).

What is the chance of getting the desired gender?
Currently, MicroSort sperm separation for female gender selection (XSort) results in an average of 88% X-bearing sperm in the sorted specimen.  MicroSort sperm separation for male gender selection (YSort) currently results in an average of 73% Y-bearing sperm in the sorted specimen.  These data are determined by fluorescence in situ hybridization (FISH) which allows the number of X- and Y-bearing sperm cells to be counted from a fraction of the sorted sample. A child of the desired gender cannot be guaranteed because the current technology does not completely exclude either female or male sperm cells from the enriched sample. Please view the Current Results page and our Journal Publication page for the most recent data.

How many tries does it take to get pregnant?
The number of attempts (cycles) necessary to become pregnant depends on many factors; including the age of the patient, the quality of the semen specimen, the type of clinical procedure (IUI, IVF, or ICSI), and numerous other factors. Our experience indicates that pregnancies are attained at approximately the same rate with MicroSort sperm separation as those without MicroSort sperm separation.  Please view the Current Results page for the most recent data.

Where is this process currently available?
The Genetics & IVF Institute (GIVF) has a MicroSort Clinic and Laboratory located in Fairfax, Virginia. There is also a MicroSort Laboratory in Laguna Hills, California in partnership with Huntington Reproductive Center. GIVF is a world-renowned genetics and infertility institute founded in 1984 and is the world-wide exclusive license holder of the MicroSort process. GIVF and the Huntington Reproductive Center have clinical facilities at these locations where patients can receive the IUI (intrauterine insemination), IVF/ICSI and PGD procedures. IUI procedures must be performed at one of these two clinical facilities affiliated with a MicroSort laboratory.  However, a specimen may be sorted at one of the MicroSort laboratories in Fairfax or Laguna Hills, frozen, and shipped to a collaborating medical facility for use in an IVF/ICSI procedure.  (view Using a Local Collaborating Physician).

What are the fees associated with MicroSort?
While research and development funds at the Genetics & IVF Institute support the MicroSort clinical trial, there is a charge for each sort to partially cover expenses.  Cycle costs  will vary depending on the medical procedure (IUI, IVF, ICSI) used. (view Cycle Costs)  Insurance will probably not cover your participation. If you have additional questions regarding costs, please contact the MicroSort office directly at  800-277-6607.  For questions regarding fees for IVF with ICSI or Preimplantation Genetic Diagnosis (PGD) at the Genetics & IVF Institute, please call 800-552-4363 or 703-698-7355.

If I have infertility benefits/coverage under my insurance plan, does that include gender selection?
At this time gender selection is not billable to insurance companies. We can provide you statements flex spending account and/or tax expense, but gender selection is a self pay service.

If I have a medically documented infertility issue can I include gender services when my insurance is billed?
The ART (Assisted Reproductive Technology) portion of your care can be billed to insurance only if there is a medically documented infertility issue. All services for theMicrosoft clinical trial and/or PGD for gender services will be self pay.

Can GIVF submit diagnostic testing to my insurance when I am seeking services for gender selection?
Without a medically documented infertility issue GIVF is unable to submit services to your insurance. However during the testing process if it is determined that you have infertility issue, GIVF will verify insurance benefits to determine possible coverage.

Are there any risks associated with using this process?
Since the application of MicroSort technology to humans has just recently become possible, only limited information is available on pregnancy rate, risks, or outcome in humans. The process is currently in an FDA clinical trial using an investigational device in accordance with FDA regulations and its use by patients requires the patients' informed consent. For further information regarding theoretical risk, refer to the discussion and other sections in our Journal Publication.

What is the purpose of a clinical trial?
New technologies are examined for medical use in a clinical trial format. A clinical trial is a study monitored by an Institutional Review Board (IRB) for various purposes, including ensuring safety and evaluating outcomes. The participants' written informed consent is obtained in such clinical investigations. 

What type of involvement is necessary on the part of the couple?
Different procedures require different levels of involvement. 

Option A: The majority of couples use MicroSort with intrauterine insemination (IUI). After all the necessary paperwork is completed, the couple must come to the MicroSort Clinic in Fairfax, Virginia or Huntington Reproductive Center Clinic in Laguna Hills, California for the IUI procedure.  There is monitoring of your ovulatory cycle that occurs prior to the IUI procedure.  This can be done with your local OB/GYN physician or done directly with one of the clinical facilities (Fairfax or Laguna Hills). On the scheduled day of the procedure, the husband will leave a specimen at one of our MicroSort Laboratories, the sperm will be sorted and the wife will have her IUI done later that same day. 

Option B: The couple wants to use a MicroSort sperm separated specimen with an IVF with ICSI  procedure and have the IVF done with their local infertility specialist. (see Using a Local Collaborating Physician )

Option C: The couple wants to use a MicroSort sperm separated specimen with an  IVF with ICSI, or Preimplantaion Genetic Diagnosis (PGD) at the Genetics & IVF Institute.  Patients should call 1-800-552-4363 or visit the Institute's website at www.givf.com The patient wants to have an IVF/ICSI or PDG with Huntington Reproductive Center.  Patients should call 1-866-472-4483 or visit their website at www.havingbabies.com.

Will freezing damage sperm?
Frozen sperm has been used successfully for insemination and pregnancy attainment for many years. Cryoprotectants are normally added to the semen sample to protect the cells during the freezing process; however, freezing and thawing does reduce the number of viable sperm cells available for insemination. The combination of cryopreservation and MicroSort sperm separation is currently best utilized with IVF and ICSI procedures.  The feasibility of using frozen sorted sperm for IUI is currently unknown.

What precautions are taken to prevent switching our semen specimen with someone else's?
Each specimen is assigned and labeled with a unique identification number when received. Each specimen identification number is maintained throughout the process to assure rigorously accurate identification and tracking of each specimen.

Can an individual naturally have an unequal proportion of X- and Y-bearing sperm cells even if there is a family history of mostly female or male offspring?
There is no information of which we are aware that would indicate some men naturally produce an unbalanced number of X- and Y-bearing sperm cells. This seems true even when there is a family history of mostly female or male offspring. If you have significant doubt about your situation, it is possible to have a specimen tested by FISH prior to using the MicroSort procedure.

Is there a waiting list?
Due to limited capacity, there may be a waiting list depending on when you desire to initiate a MicroSort cycle, although we strive to minimize delays. It is advisable to schedule several months in advance of the time you desire to use MicroSort. If a particular month's schedule is filled to capacity, individuals will be scheduled for the next available opening.

GLOSSARY OF TERMS

Clinical Trial
A clinical study, approved and monitored by an Institutional Review Board (IRB), designed for the purpose of evaluating the outcome of a new medical procedure.

Collaborator
A physician or health care provider who has executed a formal agreement with MicroSort to participate in the MicroSort clinical trial and follow guidelines approved by the Institutional Review Board (IRB).

Cryopreservation
The process of cooling and storing cells at a temperature below the freezing point (-196 C) that provides high survivability when thawed.

Cryoprotectant
A chemical component of the freezing solution used in cryopreservation that protects the cells from freeze damage.

Cycle
A menstrual cycle which begins on the first day (designated as "day 1") of menstrual bleeding.

Enriched (sorted) sample
The resulting portion of the semen specimen after MicroSort sperm separation that contains an increased number of sperm cells of the desired gender.

Flow cytometer
A scientific instrument used to measure physiological and chemical characteristics of individual cells.

Fluorescence activated cell sorter
A flow cytometer that is modified for the purpose of separating (sorting) cells based on the amount of light (fluorescence) emitted from each cell.

Fluorescence in situ hybridization (FISH)
A laboratory procedure that uses DNA specific probes and can identify whether a sperm cell contains an X or Y chromosome.

Informed consent
A document that, when signed by a patient, acknowledges he/she has been informed of the risks and benefits of a medical procedure and has had the opportunity to ask questions with all questions having been answered.

Intracytoplasmic sperm injection (ICSI)
A laboratory procedure in which a single sperm is injected directly into an egg cell for the purpose of attempting fertilization.

Intrauterine insemination (IUI)
A relatively simple clinical procedure in which a sperm sample is inserted through the natural opening of the uterus (cervix) and deposited directly into the uterus using a fine insemination catheter for the purpose of attaining fertilization and pregnancy.

In vitro fertilization (IVF)
A laboratory procedure in which fertilization is attempted by placing sperm cells in a special dish with unfertilized eggs. The resulting embryos can subsequently be transferred into the uterus or cryopreserved for future use.

Preimplantation genetic diagnosis (PGD)
A method using DNA analysis to determine genetic information on an embryo before replacement.

Sort
The process of using MicroSort flow cytometry to separate the X- or Y-bearing sperm.

X Chromosome-bearing or X-bearing
Sperm cells that contain the X (female) chromosome and will subsequently result in a female offspring after fertilization.

Y Chromosome-bearing or Y-bearing
Sperm cells that contain the Y (male) chromosome and will subsequently result in a male offspring after fertilization.