Study of the Best Blastocyst Post Transfer by aCGH
This study is not yet open for participant recruitment.
Verified August 2012 by University of Buenos Aires
Sponsor:
University of Buenos Aires
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
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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:
- Patients who have indicated an IVF
- ≥ 21 years of age
- Regular menstrual cycles every 27-35 days
- BMI less than 35
- Normal levels of FSH, LH and E2 in early follicular phase
- Antral follicles count ≥ 6
- Couple Normal karyotype
- Expansion of the triplet CGG of FMR1 gene ≤ 45 repetitions
- Pelvic transvaginal ultrasound no more than one year prior to oocyte retrieval
- Normal Hysterosalpingography made not more than 3 years prior to oocyte retrieval
- Normal Pap and breast exam no more than one year old
- Negative serology for HIV, hepatitis B and C
- Positive serology for Rubella and Varicella
- Administration of 1 mg folic acid / d in both partners from two to three months prior to the procedure
- Woman has had previous cycles of ovarian stimulation, requires a wash out period of 30 days.
- Patients must agree with the clinical trial and sign the informed consent which explains free participation in the project
- Patients can abandon participation in the project at any time.
Exclusion Criteria:
- Existence of a disease or condition that discourages achievement pregnancy
- Endometriosis grade III and IV
- Unilateral or bilateral Hydrosalpinx
- Previous cycles of IVF with poor response to ovarian stimulation (≤ 5 oocytes) or excessive response (OHSS)
- Azoospermia with TESA or TESE requiring
- Allergy to any of the drugs used in the procedure
- Carriers of genetic or chromosomal diseases
- Repeated IVF failures (≥ 5 cycles)
- Simultaneous participation in another clinical trial
Contacts and Locations
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 May 16, 2013