Sperm Sorting for Gender Selection in Infertility Treatment
Palo Alto (17 mi)Overseen byGianpiero Palermo, MD, PhD
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: N/A
Recruiting
Sponsor: Weill Medical College of Cornell University
No Placebo Group
Approved in 2 jurisdictions
Trial Summary
What is the purpose of this trial?This trial is testing a method to choose sperm that will result in either a boy or a girl before fertilization. It targets couples undergoing infertility treatment. The process involves sorting sperm by density to identify male or female sperm, then using them for fertilization procedures like IVF or intrauterine insemination.
What safety data exists for sperm sorting for gender selection?The safety data for sperm sorting methods, such as MicroSort, indicate that these techniques are generally safe and effective. Clinical trials have shown that the method does not impair fertilization or embryo development and does not increase the risk of congenital abnormalities, with rates similar to those in the general population. The observed major congenital abnormality rate is 2.05%, which aligns with spontaneous occurrences. Additionally, the method has been shown to achieve significant enrichment of X- or Y-chromosome bearing sperm, with clinical outcomes and child health comparable to standard assisted reproduction techniques. However, some concerns remain about the accuracy and potential damage to sperm, which could affect fertility, but not offspring health.35679
Is sperm sorting a promising treatment for choosing a baby's gender?Yes, sperm sorting is a promising treatment for choosing a baby's gender. It can help families balance the gender of their children and reduce the risk of having children with certain genetic diseases. Some methods have shown success in increasing the chances of having a baby of the desired gender.23468
What data supports the idea that Sperm Sorting for Gender Selection in Infertility Treatment is an effective treatment?The available research shows that sperm sorting methods, like the MicroSort technique, can effectively increase the chances of selecting the desired gender. For example, the MicroSort method can shift the natural 50:50 ratio of X and Y sperm to 90% X or 75% Y, leading to consistent results in the gender of embryos and babies. Additionally, the Ericsson albumin filtration technique reported an 80% success rate for selecting male offspring. These methods are considered safe and effective, with clinical outcomes similar to those in the general population.12356
Do I have to stop taking my current medications for this trial?The trial protocol does not specify whether you need to stop taking your current medications.
Eligibility Criteria
This trial is for couples undergoing infertility treatments like IVF or insemination who wish to select the gender of their offspring, whether for medical or non-medical reasons. Couples with severe male factor infertility cannot participate.Treatment Details
The study tests a method to choose sperm based on desired gender before using them in standard fertility treatments such as in vitro fertilization (IVF) or intrauterine insemination.
1Treatment groups
Experimental Treatment
Group I: Sperm sortingExperimental Treatment1 Intervention
Selection of gender specific spermatozoa using a multilayer density gradient
Sperm Sorting is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Sperm Sorting for:
- Family balancing
- Avoidance of sex-linked genetic diseases
🇪🇺 Approved in European Union as Sperm Sorting for:
- Family balancing
- Avoidance of sex-linked genetic diseases
Find a clinic near you
Research locations nearbySelect from list below to view details:
Center for Reproductive Medicine- Weill Cornell MedicineNew York, NY
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Who is running the clinical trial?
Weill Medical College of Cornell UniversityLead Sponsor
References
The clinical relevance of sex selection techniques. [2019]Clinical and laboratory attempts to alter the sex ratio require more complete and thorough study. Improved identification of Y-bearing sperm through chromosome evaluation rather than by F-body identification is critical to provide a more precise definition. The tentative conclusions stated below are based on an assessment of literature from which it is generally difficult to draw conclusions: 1. The timing of intercourse in relation to ovulation and subsequent fertilization appears to influence the sex ratio. More females are conceived when coitus occurs relatively close to ovulation, and more males are conceived when the sperm or egg is in the reproductive tract for a relatively longer time before conception. The influence of coital timing on the sex ratio is overall quite subtle and is not a practical method to alter the sex ratio for individual couples. 2. The use of ovulation-inducing medications slightly favors female offspring. A decrease in sex ratio of 5% to 10% has been shown in multiple studies. 3. Artificial insemination with fresh donor or homologous spermatozoa results in more male births with a reported 7% to 10% increase in the sex ratio. It appears that ovulation induction combined with artificial insemination cancels the respective influences of each on the sex ratio. 4. Sperm separation techniques using albumin (for selection of Y-bearing sperm) or Sephadex column filtration (for selection of X-bearing sperm) are the only techniques that have been reported to alter the sex ratio to a degree that is clinically relevant. Although clinical birth data are just beginning to accumulate, these methods appear to have a 70% to 80% success for selection of assumed Y-bearing sperm and a 75% to 80% success for selection of assumed X-bearing sperm. The validity of these results will remain questionable until fully detailed accounts are published and successfully repeated. Free-flow electrophoresis appears to achieve significant separation; however, the depressed postprocedure spermatozoa motility presently limits the usefulness of this procedure. 5. There is a potential to combine clinical and laboratory methods to maximize the efficiency of sex selection for interested couples. Modern methods to identify ovulation (e.g., urinary LH kits, ultrasonography) may help the timing of coitus for sex selection. Clomiphene citrate may enhance female sex preselection when Sephadex column filtration is also employed. 6. The priority of sex preselection in terms of medical, social, and demographic consideration remains to be determined. The avoidance of sex-linked genetic disorders is a reasonable and desirable goal.(ABSTRACT TRUNCATED AT 400 WORDS)
Sex selection by sperm separation and insemination. [2017]The Ericsson albumin filtration technique was used to collect a fraction rich in Y sperm for selective insemination in couples desiring a male infant. Of 35 conceptions in which sex was known at delivery or spontaneous abortion, there were 28 males (80%). Twelve pregnancies were achieved after separation of sperm in a Sephadex gel filtration system designed to allow for collection of a fraction enriched in X sperm. Seven pregnancies have resulted in females, two in males, and one in twins of each sex. One patient aborted, and one is still pregnant. While selection for either sex can be done electively, on the basis of sociologic preference, female selection has, as an additional indication, avoidance of male offspring to carriers of sex-linked diseases.
Sex-selection of human spermatozoa: evolution of current techniques and applications. [2019]Methods claiming to achieve sex selection by sperm sorting have existed for many years. Numerous applications for safe and effective selection procedures exist in current clinical practice, as sex-linked conditions could be theoretically eliminated by use of appropriate sperm for fertilization or insemination. Use of such techniques could also address the need to effect family balancing for some couples. Modern preconception sex-selection methods may be classified into two general types: those that attempt to segregate spermatozoa on the basis of subtle physical or kinetic features, and those that rely on distinctive nuclear characteristics unique either to X- or Y-chromosome bearing sperm. Laboratories providing sperm sexing using the former method have been available for some years, although the associated efficiency and reproducibility are controversial. Sex selection of spermatozoa by chromatin differences has been shown to achieve significant enrichment of X- or Y-chromosome bearing sperm, but clinical experience in humans is limited. The fundamental elements of the two approaches introduced here are reviewed and compared. Selected key historical concepts in sex selection by sperm sorting are outlined, followed by a summary of promising areas for future research.
X-Y sperm selection: fact or fiction? [2019]Selecting the gender of offspring has given rise to various and sometimes amusing stories. But regardless of which prefertilisation technique is used to influence the sex ratio of offspring it must fulfill certain criteria. First of all it must achieve a complete separation of the X and Y bearing sperm in sufficient quantities. Secondly sperm must be viable after separation and capable of fertilising. Sex preselection methods can be divided into two general groups which either separate spermatozoa on the basis of subtle physical or kinetic features or those which rely on distinctive nuclear characteristics unique either to X or Y chromosome bearing sperm. These, in turn, can be divided into in vivo methods designed to produce optimal conditions for fertilisation by either the X or Y bearing sperm, or in vitro sperm separation methods designed to separate X or Y bearing sperm. According to all published data, the different separation techniques have been shown not to be very effective. Only sex selection of spermatozoa by chromatin differences (cell sorting by flow cytometry) has demonstrated a significant enrichment of the X bearing sperm.
Gender selection: pressure from patients and industry should not alter our adherence to ethical guidelines. [2007]Patients who undergo assisted reproduction occasionally request that physicians intervene with techniques that help to determine the gender of their offspring. Conventionally, all of these methods require an invasive procedure that places both the mother and pregnancy at risk. However, for sex-linked disorders, the risk/benefit ratio is favorable; therefore, in such cases, gender selection is warranted. The recent introduction of noninvasive techniques for X- and Y-chromosome-bearing sperm sorting now provides another option for couples. However, the method is not absolute in its ability to sort sperm correctly; in many cases, the offspring are not of the desired sex. Sperm sorting has been marketed increasingly as a means for "family balancing," which is contrary to recommendations that are offered by ethics committees of several professional societies. More studies are needed with respect to the impact of gender selection on families before this method is introduced into routine practice.
Scientific aspects of preconception gender selection. [2022]Although numerous methods have been promoted as having an influence on the gender of offspring, most lack credible scientific evidence of effectiveness. Preconception gender selection has an important application in reducing the risk of having children with X-linked disease. A preconception, flow cytometric sperm sorting method of gender selection (MicroSort) is based upon the detection of differential fluorescence emitted by fluorescently stained X and Y chromosome-bearing spermatozoa. Ongoing clinical trial results illustrate the safety and efficacy of the method. Fluorescence in-situ hybridization (FISH) analysis of specimens pre- and post-sort show the 50:50 X:Y ratio in unsorted spermatozoa can be shifted to 90% X or 75% Y after sorting. Embryo gender and fetal/baby gender are consistent with post-sort FISH results. Intrauterine insemination (IUI) and IVF/ICSI (intracytoplasmic sperm injection) pregnancy rates are consistent with those reported in the assisted reproduction literature. Clinical loss rates are similar to those in the general population. The observed major congenital abnormality rate of 2.05% for babies born after using this sperm sorting method coincides with that occurring spontaneously. Current results indicate that the method is a safe and effective process and is a valuable tool for families wishing to balance the gender distribution of their children or to reduce the likelihood of having children with X-linked disease.
Sexing mammalian sperm - Where do we go from here? [2022]The only commercially viable method of sexing mammalian sperm is to use a flow cytometer to measure sperm DNA content via fluorescence of the DNA-bound fluorophore Hoechst 33342, and then sort sperm into three populations, probably X, probably Y, and undetermined. Millions of insemination doses of sexed sperm are produced annually by this procedure. Although accuracy of sexing usually exceeds 90%, this procedure of sexing one sperm at a time has serious limitations, including cost, sort rates, and damage to sperm resulting in lowered fertility, but not abnormalities in offspring. Suggested areas for research include determining how sperm are damaged and where in the process of fertilization and embryonic development the infertility is manifest. Pre and post sorting procedures are done in approximately hourly batches, and these might be changed to continuous procedures. Numerous genetic, physical, and immunological procedures for sexing millions of sperm in parallel have been proposed, but none appears to be suitable for commercialization at this time due to issues of accuracy, repeatability, damage to sperm, and other problems. However, increasing numbers of reports are appearing concerning improvements in these procedures, and it appears inevitable that one or more of them eventually will prove to be efficacious. In developing such procedures, it is critical to monitor sexing accuracy regularly by rapid and inexpensive procedures such as fluorescence in situ hybridization, quantitative PCR, or sort reanalysis by flow cytometry. Furthermore, monitoring fertility of sexed sperm such as in vitro fertilization should be integral to the development process. Intellectual property issues could be substantive.
Sperm separating techniques do not work. [2019]Techniques to sort sperm so that couples can select the sex of their children don't work, according co Australian researchers.
A non-randomized clinical trial to determine the safety and efficacy of a novel sperm sex selection technique. [2023]The desire to have offspring of a specific sex has a long history but has been particularly present with the appearance of assisted reproduction. However, embryo selection raises ethical concerns. Thus, several techniques to select sex-specific spermatozoa have been proposed but carry limitations. There are many variations of each technique, and some are time consuming and costly. Concerns about effectiveness and safety have also rendered many of them unappealing. Therefore, we propose a novel sperm sex selection technique (SST) that appears to be consistently safe and effective. A single-center, non-randomized clinical trial was designed. We included 1,317 couples, who were assigned to one of two groups: ICSI/PGTA or ICSI/PGTA+GS. Ejaculates from male partners of couples in the ICSI/PGTA+GS group (n = 105) were processed using SST to enrich spermatozoa for their desired sex. Standard sperm processing was carried out for couples undergoing PGT-A solely for aneuploidy (n = 1,212), comprising the ICSI/PGTA control group. To validate the efficacy of our technique, we performed an analysis on spermatozoa pre- and post-selection, followed by an assessment of the proportion of the conceptuses' sex to confirm clinical reliability. We also followed up on ICSI clinical outcomes and child/newborn health to establish the safety of our method. Our main outcome measures included the proportion of spermatozoa and embryos enriched for female and male sex, as well as embryo euploidy rates and ICSI clinical outcomes. These outcomes were compared between the two groups. For the ICSI/PGTA group (n = 1,212) (maternal age, 37.0±4yrs; paternal age, 39.1±6yrs), with ejaculated spermatozoa processed in the standard fashion, 2,303 ICSI cycles (1.2±1) yielded an 81.0% (14,375/17,737) fertilization. PGT-A results indicated a euploidy rate of 73.1% (n = 3,718) for female and 72.4% (n = 3,054) for male embryos. These couples achieved a 76.4% (699/915) implantation and 65.2% (597/915) clinical pregnancy rate, with 551 deliveries (48.5% female, 51.5% male). All 105 men in the ICSI/PGTA+GS group had sperm specimens with an equal sex distribution at baseline. Of them, 59 (paternal age, 40.9±6yrs) who desired female offspring obtained an 81.6% enrichment after SST. They underwent 73 ICSI cycles with their partners (maternal age, 37.9±4yrs), achieving a 77.3% (583/754) fertilization. This resulted in 79.1% (231/292) female embryos that generated a 79.3% (23/29) implantation rate, with 16 singleton deliveries of the desired female sex without major or minor congenital malformations. Forty-six couples (maternal age, 37.3±4yrs; paternal age, 40.7±6yrs) desiring male offspring obtained an 80.8% sperm sex enrichment. They underwent 50 ICSI cycles, achieving a 75.4% (462/613) fertilization and equivalent proportion of male embryos (223/280, 79.6%). Their implantation was 90.5% (19/21), with 13 singleton deliveries of healthy male offspring. Furthermore, 78.8% (182/231) of female and 66.4% (148/223) of male embryos from the ICSI/PGTA+GS cohort were euploid. These euploid rates were comparable to those from the ICSI/PGTA group. In couples undergoing ICSI with PGT-A, SST consistently enriched spermatozoa, resulting in a higher proportion of embryos and thus offspring of the desired sex. Moreover, SST did not impair the fertilization or embryo developmental competence of spermatozoa, nor did it affect offspring health. Trial registration: Clinicaltrials.gov NCT05500573.