Study of the Best Blastocyst Post Transfer by aCGH

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. Identifier: NCT01664546
Recruitment Status : Unknown
Verified August 2012 by Roberto Coco, University of Buenos Aires.
Recruitment status was:  Not yet recruiting
First Posted : August 14, 2012
Last Update Posted : August 15, 2012
Fecunditas Instituto de Medicina Reproductiva
Hospital del Mar
Red Latinoamericana de Reproducción Asistida
Information provided by (Responsible Party):
Roberto Coco, University of Buenos Aires

Brief Summary:
An Observational, blind and prospective study of Preimplantational Aneuploidy Screening by aCGH in Trophectoderm Biopsy

Condition or disease Intervention/treatment
Pregnancy Spontaneous Abortions Stillbirth Procedure: Trophectoderm biopsy

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Study of the Best Blastocyst Post Transfer by aCGH
Study Start Date : September 2012
Estimated Primary Completion Date : September 2013
Estimated Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Group/Cohort Intervention/treatment
Molecular blastocyst karyotype
Trophectoderm biopsy for genetic study by aCGH
Procedure: Trophectoderm biopsy

Primary Outcome Measures :
  1. Clinical pregnancy [ Time Frame: Five weeks after blastocyst transfer ]
    Gestational sac with a heartbeat

Secondary Outcome Measures :
  1. Trophectoderm molecular karyotype [ Time Frame: After blastocyst transfer ]
    Trophectoderm ploidy Imbalanced chromosome complement

Other Outcome Measures:
  1. Spontaneous miscarriage [ Time Frame: During pregnancy ]

    Absence of vital signs

    Abortion product


  2. Non pregnancy [ Time Frame: Two weeks after transfer ]
    Beta hCG

  3. Fetal karyotype [ Time Frame: Sixteenth week of pregnancy ]
    Karyotype in amniocytes obtained by amniocentesis

  4. Newborn karyotype [ Time Frame: At delivery ]
    Lymphocyte culture of cord blood

Biospecimen Retention:   Samples With DNA
Removed cells from human trophectoderm

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients who require IVF/ICSI procedure to achieve pregnancy

Inclusion Criteria:Each patient should apply the criteria in a period not exceeding 6 months prior to aspiration. The criteria are:

  1. Patients who have indicated an IVF
  2. ≥ 21 years of age
  3. Regular menstrual cycles every 27-35 days
  4. BMI less than 35
  5. Normal levels of FSH, LH and E2 in early follicular phase
  6. Antral follicles count ≥ 6
  7. Couple Normal karyotype
  8. Expansion of the triplet CGG of FMR1 gene ≤ 45 repetitions
  9. Pelvic transvaginal ultrasound no more than one year prior to oocyte retrieval
  10. Normal Hysterosalpingography made not more than 3 years prior to oocyte retrieval
  11. Normal Pap and breast exam no more than one year old
  12. Negative serology for HIV, hepatitis B and C
  13. Positive serology for Rubella and Varicella
  14. Administration of 1 mg folic acid / d in both partners from two to three months prior to the procedure
  15. Woman has had previous cycles of ovarian stimulation, requires a wash out period of 30 days.
  16. Patients must agree with the clinical trial and sign the informed consent which explains free participation in the project
  17. Patients can abandon participation in the project at any time.

Exclusion Criteria:

  1. Existence of a disease or condition that discourages achievement pregnancy
  2. Endometriosis grade III and IV
  3. Unilateral or bilateral Hydrosalpinx
  4. Previous cycles of IVF with poor response to ovarian stimulation (≤ 5 oocytes) or excessive response (OHSS)
  5. Azoospermia with TESA or TESE requiring
  6. Allergy to any of the drugs used in the procedure
  7. Carriers of genetic or chromosomal diseases
  8. Repeated IVF failures (≥ 5 cycles)
  9. Simultaneous participation in another clinical trial

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 identifier (NCT number): NCT01664546

Contact: Roberto Coco, PhD 541149613091
Contact: Maria E Ducatelli, PhD 541149626309

Fecunditas Reproductive Medicine Institute Not yet recruiting
Buenos Aires, Argentina, 1030
Contact: Roberto Coco, PhD    54119613091   
Contact: Maria E Ducatelli, PhD    54119626309   
Sponsors and Collaborators
University of Buenos Aires
Fecunditas Instituto de Medicina Reproductiva
Hospital del Mar
Red Latinoamericana de Reproducción Asistida
Study Director: Roberto Coco, PhD UBA

Responsible Party: Roberto Coco, Director, University of Buenos Aires Identifier: NCT01664546     History of Changes
Other Study ID Numbers: Funsare - 001
First Posted: August 14, 2012    Key Record Dates
Last Update Posted: August 15, 2012
Last Verified: August 2012

Additional relevant MeSH terms:
Abortion, Spontaneous
Fetal Death
Pregnancy Complications
Pathologic Processes