Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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?

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02149251
Recruitment Status : Completed
First Posted : May 29, 2014
Last Update Posted : January 22, 2015
Sponsor:
Information provided by (Responsible Party):
AbdelGany Hassan, Cairo University

Brief 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.

Condition or disease Intervention/treatment
Pregnancy Genetic: Pre-genetic diagnosis

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


Layout table for study information
Study Type : Observational
Actual Enrollment : 11006 participants
Observational Model: Case Control
Time Perspective: Retrospective
Official Title: 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?
Study Start Date : May 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Miscarriage

Group/Cohort Intervention/treatment
Pre-genetic diagnosis
Women in this group had ICSI and PGD to exclude genetically affected children or for sex selection
Genetic: Pre-genetic diagnosis
Control group
This group will include women who had IVF without PGD



Primary Outcome Measures :
  1. Miscarriage [ Time Frame: 28 weeks after the pregnancy test ]

Secondary Outcome Measures :
  1. pregnancy [ Time Frame: 5 weeks after embryo transfer ]
    pregnancy was defined as the presence of an intrauterine gestational sac 5 weeks after embryo transfer



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
All women who had IVF/ICSI over the past 3 years in Dar AlTeb subfertility centre will be included in the study
Criteria

Inclusion Criteria:

  • IVF/ICSI
  • Age 20-40 years

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02149251


Locations
Layout table for location information
Egypt
Dar AlTeb subfertility centre
Cairo, Egypt
Sponsors and Collaborators
Cairo University
Investigators
Layout table for investigator information
Principal Investigator: AbdelGany MA Hassan, MRCOG, MD Cairo University

Publications:

Layout table for additonal information
Responsible Party: AbdelGany Hassan, Lecturer of Gynecology and Obstetrics, Cairo University
ClinicalTrials.gov Identifier: NCT02149251     History of Changes
Other Study ID Numbers: Gany 125
First Posted: May 29, 2014    Key Record Dates
Last Update Posted: January 22, 2015
Last Verified: November 2014

Keywords provided by AbdelGany Hassan, Cairo University:
Pre-genetic diagnosis
ICSI

Additional relevant MeSH terms:
Layout table for MeSH terms
Abortion, Spontaneous
Pregnancy Complications