Does Preimplantation Genetic Diagnosis for Sex Selection Affect the Pregnancy and Miscarriage Rates in Women With an Expected Good Ovarian Response Undergoing IVF/ICSI Cycles?
NCT ID: NCT02149251
Last Updated: 2015-01-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
11006 participants
OBSERVATIONAL
2014-05-31
2014-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effectiveness of PGT-A: IVF Versus ICSI
NCT03708991
Cell-free DNA Analysis of Spent Embryo Culture Media as a Non-invasive Approach for Preimplantation Genetic Diagnosis
NCT07076719
Follow-up With Preimplantation Genetic Testing Patients
NCT04477863
Comparison Between Biopsied and Non-biopsied Intracytoplasmatic Sperm Injection (ICSI) Embryos and Natural Pregnancy Embryos
NCT04280757
Predictive Value of Embryonic Testing
NCT03604107
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Women had standard pituitary down-regulation with GnRHa (Triptorelin 0.1mg, Decapeptyl® Ferring, Germany) day 7 after ovulation of previous cycle or on day 21 of the oral contraceptive cycles. GnRHa was continued for 2 weeks. Human menopausal gonadotrophin(HMG) (Merional ®IBSA) 150-300 IU/day was administered until the day of HCG administration, Transvaginal oocyte retrieval will be performed 34-36 h after the administration of HCG.
After fertilization, biopsy was obtained from cleavage stage embryos. FISH analysis was used to distinguish embryos with balanced and unbalanced chromosomal abnormalities for carriers of structural chromosomal aberrations. In the analysis of translocations, unique FISH probes that flank the breakpoints of each translocation or that require the use of subtelomeric probes (specific to the chromosome ends of the translocated segments) for each affected individual must be designed and validated to detect normal and balanced products in embryonic tissue.
The principle of PGD by FISH is that target-specific DNA probes labelled with different fluorochromes or haptens can be used to detect the copy number of specific loci, and thereby to detect chromosome imbalance associated with meiotic segregation of chromosome rearrangements which includes the Robertsonian translocations, reciprocal translocations, inversions, and complex rearrangements. FISH can also be used to select female embryos in families with X-linked disease Polymerase chain reaction (PCR) has been used to diagnose monogenic disorders. PCR is used to amplify sufficient DNA from embryo cells . A blastomere is placed in a solution that lyses the cell and releases the DNA and the PCR reaction mix is then added to begin the PCR. Because of its high sensitivity, contamination of the study sample with extraneous DNA is a danger and has led to the adoption of rigorous laboratory procedures and standards, such as the use of intracytoplasmic sperm injection.
PGD analysis results were available on day 5 after oocyte retrieval. If possible, 2 unaffected embryos were transferred and the rest of the unaffected embryos were cryopreserved.
Women were followed up and a pregnancy test was performed to detect pregnancy, pregnant women were followed up and any pregnancy complications were recorded
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
RETROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Pre-genetic diagnosis
Women in this group had ICSI and PGD to exclude genetically affected children or for sex selection
Pre-genetic diagnosis
Control group
This group will include women who had IVF without PGD
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Pre-genetic diagnosis
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Age 20-40 years
Exclusion Criteria
* Poor responders defined according to the Bologna criteria
* Recurrent miscarriage
20 Years
40 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Cairo University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
AbdelGany Hassan
Lecturer of Gynecology and Obstetrics
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
AbdelGany MA Hassan, MRCOG, MD
Role: PRINCIPAL_INVESTIGATOR
Cairo University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Dar AlTeb subfertility centre
Cairo, , Egypt
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Handyside AH, Kontogianni EH, Hardy K, Winston RM. Pregnancies from biopsied human preimplantation embryos sexed by Y-specific DNA amplification. Nature. 1990 Apr 19;344(6268):768-70. doi: 10.1038/344768a0.
Harton GL, De Rycke M, Fiorentino F, Moutou C, SenGupta S, Traeger-Synodinos J, Harper JC; European Society for Human Reproduction and Embryology (ESHRE) PGD Consortium. ESHRE PGD consortium best practice guidelines for amplification-based PGD. Hum Reprod. 2011 Jan;26(1):33-40. doi: 10.1093/humrep/deq231. Epub 2010 Oct 21.
Klitzman R, Zolovska B, Folberth W, Sauer MV, Chung W, Appelbaum P. Preimplantation genetic diagnosis on in vitro fertilization clinic websites: presentations of risks, benefits and other information. Fertil Steril. 2009 Oct;92(4):1276-1283. doi: 10.1016/j.fertnstert.2008.07.1772. Epub 2008 Sep 30.
Haapaniemi Kouru K, Malmgren H, Nordenskjold M, Fridstrom M, Csemiczky G, Blennow E. One-cell biopsy significantly improves the outcome of preimplantation genetic diagnosis (PGD) treatment: retrospective analysis of 569 PGD cycles at the Stockholm PGD centre. Hum Reprod. 2012 Sep;27(9):2843-9. doi: 10.1093/humrep/des235. Epub 2012 Jun 26.
Olivius C, Friden B, Borg G, Bergh C. Why do couples discontinue in vitro fertilization treatment? A cohort study. Fertil Steril. 2004 Feb;81(2):258-61. doi: 10.1016/j.fertnstert.2003.06.029.
Sills ES, Palermo GD. Preimplantation genetic diagnosis for elective sex selection, the IVF market economy, and the child--another long day's journey into night? J Assist Reprod Genet. 2002 Sep;19(9):433-7. doi: 10.1023/a:1016819908612.
Ehrich K, Williams C, Farsides B, Sandall J, Scott R. Choosing embryos: ethical complexity and relational autonomy in staff accounts of PGD. Sociol Health Illn. 2007 Nov;29(7):1091-106. doi: 10.1111/j.1467-9566.2007.01021.x.
Inzunza J, Iwarsson E, Fridstrom M, Rosenlund B, Sjoblom P, Hillensjo T, Blennow E, Jones B, Nordenskjold M, Ahrlund-Richter L. Application of single-needle blastomere biopsy in human preimplantation genetic diagnosis. Prenat Diagn. 1998 Dec;18(13):1381-8. doi: 10.1002/(sici)1097-0223(199812)18:133.0.co;2-n.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Gany 125
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.