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PregnancyNCT02149251

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?

An observational study of Pregnancy, run by Cairo University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Records of women who had Pre-genetic diagnosis (PGD) over the last 3 years will be reviewed and its outcome will be compared to other records of women who had IVF/ICSI without PGD. Read more about this study

Who is it for?
Ages 20 to 40 years, women onlyHealthy volunteers can take part
Conditions the study is for
Pregnancy
What is being tested?
Pre-genetic diagnosis
How many people
11,006 participants
Where
1 siteEgypt
Study dates
May 2014to Oct 2014
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 40 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Study population: All women who had IVF/ICSI over the past 3 years in Dar AlTeb subfertility centre will be included in the study

Who may be able to join

  • IVF/ICSI
  • Age 20-40 years

Who cannot join

  • Frozen embryos
  • Poor responders defined according to the Bologna criteria
  • Recurrent miscarriage

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Dar AlTeb subfertility centre

    Cairo

Other trials in Egypt

About this study

Records of women who had Pre-genetic diagnosis (PGD) over the last 3 years will be reviewed and its outcome will be compared to other records of women who had IVF/ICSI without PGD.

Read the detailed description

Records of women who had PGD over the last 3 years will be reviewed and its outcome will be compared to other records of women who had IVF/ICSI without PGD Before starting the PGD process couples were seen by a geneticist to assess the feasibility of the procedure for each couple. Couples were then counselled by a gynaecologist specialised in IVF to assess their fertility status and explain the whole procedure including the expected success rates and risks of IVF.

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
Pregnancy
Being tested
Pre-genetic diagnosis
Keywords
Pre-genetic diagnosis, ICSI

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pre-genetic diagnosisGenetic

Study groups in NCT02149251
Study groupRoleWhat they receive
Pre-genetic diagnosisWomen in this group had ICSI and PGD to exclude genetically affected children or for sex selection
Receives: Genetic: Pre-genetic diagnosis
Control groupThis group will include women who had IVF without PGD

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Miscarriage

    Measured: 28 weeks after the pregnancy test

Secondary outcomes (1)

  1. pregnancy

    pregnancy was defined as the presence of an intrauterine gestational sac 5 weeks after embryo transfer

    Measured: 5 weeks after embryo transfer

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 May 2014 (estimated)
  2. Study startMay 2014
  3. Primary completionOct 2014
  4. Study completionOct 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Retrospective
Enrolment
11,006 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02149251
Sponsor's protocol ID
Gany 125
Status last verified
Nov 2014
First submitted
24 May 2014
Last updated
22 Jan 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 2330030

  • 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.

    PubMed 20966462

  • 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.

    PubMed 18829009

  • 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.

    PubMed 22736325

  • 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.

    PubMed 14967352

  • 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.

    PubMed 12408539

  • 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.

    PubMed 18092985

  • 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.

    PubMed 9949438

Questions about this trial

What is this clinical trial studying?

An observational study of Pregnancy, run by Cairo University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Miscarriage (time frame: 28 weeks after the pregnancy test). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02149251, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2015.

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