Study of the Best Blastocyst Post Transfer by aCGH
1 other identifier
observational
150
1 country
1
Brief Summary
An Observational, blind and prospective study of Preimplantational Aneuploidy Screening by aCGH in Trophectoderm Biopsy
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 3, 2012
CompletedFirst Posted
Study publicly available on registry
August 14, 2012
CompletedStudy Start
First participant enrolled
September 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedAugust 15, 2012
August 1, 2012
1 year
August 3, 2012
August 14, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Clinical pregnancy
Gestational sac with a heartbeat
Five weeks after blastocyst transfer
Secondary Outcomes (1)
Trophectoderm molecular karyotype
After blastocyst transfer
Other Outcomes (4)
Spontaneous miscarriage
During pregnancy
Non pregnancy
Two weeks after transfer
Fetal karyotype
Sixteenth week of pregnancy
- +1 more other outcomes
Study Arms (1)
Molecular blastocyst karyotype
Trophectoderm biopsy for genetic study by aCGH
Interventions
Eligibility Criteria
Adult patients who require IVF/ICSI procedure to achieve pregnancy
You may qualify if:
- 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.
- +2 more criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Buenos Aireslead
- Fecunditas Instituto de Medicina Reproductivacollaborator
- Hospital del Marcollaborator
- Red Latinoamericana de Reproducción Asistidacollaborator
Study Sites (1)
Fecunditas Reproductive Medicine Institute
Buenos Aires, Buenos Aires, 1030, Argentina
Biospecimen
Removed cells from human trophectoderm
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Roberto Coco, PhD
UBA
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
August 3, 2012
First Posted
August 14, 2012
Study Start
September 1, 2012
Primary Completion
September 1, 2013
Study Completion
September 1, 2014
Last Updated
August 15, 2012
Record last verified: 2012-08