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?

January 20, 2015 updated by: AbdelGany Hassan, Cairo University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Actual)

11006

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Dar AlTeb subfertility centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

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

Description

Inclusion Criteria:

  • IVF/ICSI
  • Age 20-40 years

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Miscarriage
Time Frame: 28 weeks after the pregnancy test
28 weeks after the pregnancy test

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pregnancy
Time Frame: 5 weeks after embryo transfer
pregnancy was defined as the presence of an intrauterine gestational sac 5 weeks after embryo transfer
5 weeks after embryo transfer

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

May 24, 2014

First Submitted That Met QC Criteria

May 28, 2014

First Posted (Estimate)

May 29, 2014

Study Record Updates

Last Update Posted (Estimate)

January 22, 2015

Last Update Submitted That Met QC Criteria

January 20, 2015

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Gany 125

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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