Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00802295
Other study ID # VLC-JR-0204-307-11
Secondary ID
Status Completed
Phase N/A
First received December 3, 2008
Last updated September 17, 2009
Start date December 2008
Est. completion date April 2009

Study information

Verified date September 2009
Source Instituto Valenciano de Infertilidad, IVI VALENCIA
Contact n/a
Is FDA regulated No
Health authority Spain: Ministry of Health
Study type Interventional

Clinical Trial Summary

Our working hypothesis is that patients undergoing "in vitro" fertilization (IVF) with higher response to ovarian stimulation protocols recover a higher number of oocytes and, this elevated response could be translated into increased incidence of chromosomally abnormal embryos. Our objective is to develop a prospective study on healthy young donors, with a previous cycle with high ovarian response (>20 oocytes and/or E2 levels the day of the hCG injection >3000 pg/mL), but without developing mild or severe hyperstimulation syndrome. After signing a proper written consent, these donors would agree to undergo two subsequent stimulation cycles following two different protocols. In one cycle the stimulation pattern would be similar to the previous one, with elevated response and, in another cycle the amount of gonadotropins would be cut down in order to obtain lower ovarian response. Oocytes obtained in each cycle would be donated to anonymous recipients and after fertilization, embryo quality and chromosomal status of the resulting embryos would be evaluated. Preimplantation genetic diagnosis (PGD) will be performed on day-3 embryos and chromosomes 13, 15, 16, 17, 18, 21, 22, X and Y would be analyzed by fluorescence "in situ" hybridization (FISH).


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date April 2009
Est. primary completion date April 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 29 Years
Eligibility Inclusion Criteria:

- Healthy women between 18 - 29

- with previous cycle with standard dosis of Gonadotrophin and high response to the treatment (> 20 oocytes)

- No symptom of OHSS

Exclusion Criteria:

- donors with 2 previous miscarriages

- PCO

- Severe Male Factor

Study Design

Allocation: Non-Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Drug:
Gonadotrophins
Administration of standard ovarian stimulation protocol
Low dosis Gonadotrophin


Locations

Country Name City State
Spain Instituto Valenciano de Infertilidad Valencia

Sponsors (1)

Lead Sponsor Collaborator
Instituto Valenciano de Infertilidad, IVI VALENCIA

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Aneuploidy rate with two different stimulation protocols. three months No
Secondary Normal blastocyst rate three months No
See also
  Status Clinical Trial Phase
Completed NCT03673592 - Clinical Value of Mosaicism Diagnosis on the Trophectoderm Biopsies
Completed NCT02268786 - Single Embryo TrAnsfeR of Euploid Embryo N/A
Completed NCT01574404 - Polar Body Biopsy for Preimplantation Genetic Screening N/A
Not yet recruiting NCT03981120 - The Effect of Acupuncture on Pregnancy Rates in Women Undergoing in Vitro Fertilization With Preimplantation Genetic Screening N/A
Recruiting NCT05547555 - Invasive PGT-A Embryo Selection Versus Non Invasive PGT-A Assisted Embryo Selection
Recruiting NCT05545995 - Time Lapse Assisted Embryo Selection Versus Non Invasive PGT-A Assisted Embryo Selection
Completed NCT02787486 - Expanded Noninvasive Genomic Medical Assessment: The Enigma Study
Active, not recruiting NCT04865367 - How Secreted-embryo-derived Trypsin Initiates, Maintains and Terminates Ca2+ Signals in Uterine Epithelial Cells
Completed NCT01052688 - Noninvasive Screening for Affected Pregnancies: Assay Development & Optimization in Affected Pregnancies
Completed NCT03816423 - Use of Videos to Improve Patient Knowledge on Prenatal Genetics N/A
Recruiting NCT03449225 - Prenatal Computer-Aided Genetics Education Module N/A
Completed NCT03860064 - Aneuploidy Rates of in Vitro Matured Oocytes
Recruiting NCT04000152 - RCT Study to Validate niPGT-A Clinical Benefit. N/A
Recruiting NCT06419127 - Embryo Assessment Utilizing Timelapse Imaging in Conjunction With Preimplantation Genetic Testing for Aneuploidy With Next Generation Sequencing
Active, not recruiting NCT04901247 - A Time-lapse Monitoring Prospective Study
Active, not recruiting NCT05492981 - Does an Educational Video for Aneuploidy Screening Improve Informed Choice Among Pregnant Women? N/A
Completed NCT04420858 - Effect of Video Education on Patients' Knowledge and Attitudes of Privacy in Prenatal Genetics N/A
Completed NCT01597063 - Clinical Evaluation of the SEQureDx Trisomy Test in Low Risk Pregnancies N/A
Completed NCT02284399 - National Prevalence and Impact of Noninvasive Prenatal Testing
Terminated NCT01545674 - Prenatal Non-invasive Aneuploidy Test Utilizing SNPs Trial