Gender selection test – Baby Gender
The best choice for gender selection
1. Presentation. What is a gender selection test?
Baby Gender is a gender selection test used alongside in-vitro fertilization (IVF) to screen abnormalities in embryos for 5 chromosome; 21, 18, 13, X and Y prior to transfer. The information obtained also helps us to select the sex of the baby prior to transfer.
The appropriate number of chromosomes is necessary for normal growth and development. There are 24 chromosome types: twenty-two autosome pairs (designated 1-22) and two sex chromosomes X and Y.
2. Objective. What is it used for?
Baby Gender identifies chromosomal abnormalities in chromosome 21, 18, 13, X & Y prior to transfer in order to know if the embryo is male or female and is normal for chromosome 21, 18, 13, X & Y
Baby Gender test is comprised of five main steps. Your fertility center will perform the first three steps including in vitro fertilization, embryo biopsy, and cell preparation. Then samples are then shipped to IGENOMIX, where the analysis is performed.
In Vitro Fertilization (IVF): Baby Gender test requires cell(s) from embryos to be analyzed; therefore, an in vitro fertilization procedure is required. Your fertility/IVF center will advise you on this process and may require a separate consent form. ICSI (intracytoplasmic sperm injection) may be performed to reduce the risk of test errors due to cell contamination.
Biopsy, Cell Preparation and Transport: Biopsy, cell preparation and transport will be taken care of by your IVF clinic. IGENOMIX can analyze biopsies from day-3 or day-5 embryos. Your physician will determine the type of biopsy procedure. For the embryo biopsy, the embryologist at your center will remove a single cell from the embryo on a day-3 biopsy (called a blastomere biopsy) or multiple cells on a day-5 biopsy (called a trophectoderm biopsy). The embryos will remain at your IVF center. After the biopsy procedure, cell(s) are washed and transferred to a small test tube. Then the samples are transported by special courier for either same day delivery or overnight delivery to the IGENOMIX Laboratory.
Analysis and Reporting of Results: The analysis of the cells is performed by IGENOMIX using advanced NGS techniques known as DNA extraction and quantitative PCR with polymorphic markers. Once the analysis is completed at the IGENOMIX laboratory, your IVF physician will receive a report with the test results. Your physician will decide which embryos to transfer based on these results.
1) Does the BabyGender test process include an unlimited number of embryos?
2) How are samples obtained and collected?
The sample is obtained by blastomere biopsy from day 3 embryos or by sampling various trophoectoderm cells on day 5. The biopsied cells are collected in a microtube containing sterile solution, and are sent in a cold container. Once the sample is received, it is maintained at ‐20 °C until it is processed.
3) Does BabyGender analyze chromosomal abnormalities?
YES, but test only detect chromosomal abnormalities for Chromosome 21, 18, 13, X & Y. No, other birth defects or genetic/developmental anomalies are not detected in gender selection testing:
- Birth defects.
BabyGender test can identify trisomy of chromosome 21, 18 & 13. As per studies, there is a 3-5% risk in the general population of birth defects. These may be caused by genetic and/or non-genetic etiologies. For a complete genetic screening we have a Carrier Genetic Test (CGT). BabyGender is not the test done to identify series of general birth defects.
- Single gene mutations.
BabyGender test does not analyze specific genes and cannot detect conditions caused by single gene mutations, such as Sickle Cell anemia, cystic fibrosis or Tay-Sachs disease. Any known genetic conditions in the family should be discussed with your fertility doctor.
- Uniparental disomy (UPD).
UPD is the presence of two copies of a given chromosome from one parent and none from the other. UPD for certain chromosomes is associated with particular genetic syndromes or medical, cognitive or physical disabilities.
Is a numerical change in a whole set of chromosomes. Polyploidy may arise from fertilization of an egg by more than one sperm (polyspermia), fertilization of a diploid egg, or fertilization by a diploid sperm.
Is more than one chromosomally distinct cell into the same embryo. Mosaicism occurs by chance during embryonic development and can underlie birth defects or cognitive impairment in individuals.
4) What are the limitations of the test?
- Risks of embryo biopsy:
Thus far, babies born after different types of procedures that include embryo biopsy have had a similar rate of birth defects to babies in the general population. Although data has shown that embryo biopsy has no adverse impact on growth or medical outcomes, there may be a risk of decreased viability of the embryo due to the biopsy procedure itself.
- Risks of abnormal embryos:
BabyGender test detects only chromosomal abnormalities in chromosome 21, 18, 13, X & Y, is not a method to diagnose complete 23 pairs of chromosomal (numeric or structural) or genetic abnormalities. In cases of history of unexplained infertility, repetitive implantation failure, previous miscarriages or birth defects in previous offspring, IGENOMIX advises to carry out PGS (Preimplantion Genetic Screening) in selected embryos.
Misdiagnosis due to Test Error: There remains an empirically determined 1% chance of a misdiagnosis.
- No diagnosis:
There is a chance of uncontrollable problems with transportation, such as weather and air travel issues, or other circumstances beyond the control of IGENOMIX that would not allow results to be obtained in time for embryo transfer. There is also a chance that the sample received in the IGENOMIX laboratory is unacceptable for analysis and results can’t be obtained from the sample provided. On rare occasions, genetic testing cannot be performed due to improper biopsy techniques, loss of biopsied cells, or poor DNA quality (often found in damaged or dying cells). IGENOMIX is not responsible for any sample before it arrives at the IGENOMIX laboratory.
- No selected embryos to transfer:
There is a chance that all embryo samples tested during an IVF cycle will be found as a female or male, in this case Doctor and patients must decide whether to transfer embryos of a different gender than desired. Likewise, there is also a chance that an embryo sample will be the desired gender, but the embryo may not develop normally and will not be selected for transfer.
- Intracytoplasmic Sperm Injection (ICSI):
ICSI as a method of fertilization is recommended, but not required prior to gender selection. If ICSI is not performed, there is an increased risk of “misdiagnosis results” on one or more samples due to contamination of the sperm.
5) Should there be a period of sexual abstinence prior to sample collection?
Abstinence from intercourse is recommended for two weeks prior to egg retrieval. Sperm can survive several days in a woman’s body and not all eggs may be retrieved. A misdiagnosis could result if a spontaneous pregnancy occurs.