Study of the Best Blastocyst Post Transfer by aCGH

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by University of Buenos Aires.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborators:
Fecunditas Instituto de Medicina Reproductiva
Hospital del Mar de la Universidad Autónoma de Barcelona
Red Latinoamericana de Reproducción Asistida
Information provided by (Responsible Party):
Roberto Coco, University of Buenos Aires
ClinicalTrials.gov Identifier:
NCT01664546
First received: August 3, 2012
Last updated: August 14, 2012
Last verified: August 2012
  Purpose

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


Condition Intervention
Pregnancy
Spontaneous Abortions
Stillbirth
Procedure: Trophectoderm biopsy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Study of the Best Blastocyst Post Transfer by aCGH

Resource links provided by NLM:


Further study details as provided by University of Buenos Aires:

Primary Outcome Measures:
  • Clinical pregnancy [ Time Frame: Five weeks after blastocyst transfer ] [ Designated as safety issue: Yes ]
    Gestational sac with a heartbeat


Secondary Outcome Measures:
  • Trophectoderm molecular karyotype [ Time Frame: After blastocyst transfer ] [ Designated as safety issue: No ]
    Trophectoderm ploidy Imbalanced chromosome complement


Other Outcome Measures:
  • Spontaneous miscarriage [ Time Frame: During pregnancy ] [ Designated as safety issue: Yes ]

    Absence of vital signs

    Abortion product

    Stillbirth


  • Non pregnancy [ Time Frame: Two weeks after transfer ] [ Designated as safety issue: Yes ]
    Beta hCG

  • Fetal karyotype [ Time Frame: Sixteenth week of pregnancy ] [ Designated as safety issue: Yes ]
    Karyotype in amniocytes obtained by amniocentesis

  • Newborn karyotype [ Time Frame: At delivery ] [ Designated as safety issue: Yes ]
    Lymphocyte culture of cord blood


Biospecimen Retention:   Samples With DNA

Removed cells from human trophectoderm


Estimated Enrollment: 150
Study Start Date: September 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Molecular blastocyst karyotype
Trophectoderm biopsy for genetic study by aCGH
Procedure: Trophectoderm biopsy

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adult patients who require IVF/ICSI procedure to achieve pregnancy

Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01664546

Contacts
Contact: Roberto Coco, PhD 541149613091 robertococo@fecunditas.com.ar
Contact: Maria E Ducatelli, PhD 541149626309 mariaducatelli@yahoo.com.ar

Locations
Argentina
Fecunditas Reproductive Medicine Institute Not yet recruiting
Buenos Aires, Argentina, 1030
Contact: Roberto Coco, PhD    54119613091    robertococo@fecunditas.com.ar   
Contact: Maria E Ducatelli, PhD    54119626309    mariaducatelli@yahoo.com.ar   
Sponsors and Collaborators
University of Buenos Aires
Fecunditas Instituto de Medicina Reproductiva
Hospital del Mar de la Universidad Autónoma de Barcelona
Red Latinoamericana de Reproducción Asistida
Investigators
Study Director: Roberto Coco, PhD UBA
  More Information

No publications provided

Responsible Party: Roberto Coco, Director, University of Buenos Aires
ClinicalTrials.gov Identifier: NCT01664546     History of Changes
Other Study ID Numbers: Funsare - 001
Study First Received: August 3, 2012
Last Updated: August 14, 2012
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Argentina: Human Research Bioethics Committee

Additional relevant MeSH terms:
Abortion, Spontaneous
Pregnancy Complications

ClinicalTrials.gov processed this record on September 30, 2014