Assessment of Implantation Potential of Embryos by Time-lapse Technology
This trial is active, not recruiting.
|Conditions||embryo/fetus death, blastocyst disintegration, aneuploidy, complication of implant, chemical pregnancy|
|Treatment||recombinant follicle stimulating hormone (rfsh)|
|Sponsor||Bloom IVF and Fertility Centre|
|Collaborator||Padmashree Dr. D. Y. Patil Medical College|
|Start date||December 2012|
|End date||March 2013|
|Trial size||200 participants|
|Trial identifier||NCT01760278, Study of embryo morphokinetics, Time-lapse monitoring|
1. Culture conditions of developing embryos are highly controlled in the Embryoscope and are monitored by Time-lapse videography to produce 3D images at different stages.This cannot be done under conventional culture conditions.
2. The 3D images thus produced,are analysed with the help of Embryoviewer, a part of the Embryoscope,through latest software.
3. Embryoviewer also identifies embryos for transfer, freezing and to be discarded.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
No.of top quality embryos produced in both the arms, study arm and control arm.
time frame: 2 weeks
time frame: 6 weeks after embryo transfer (ET)
Female participants from 21 years up to 39 years old.
Inclusion Criteria: 1. Women of age 21-39 yrs. 2. Basal FSH < 12mIU/ml 3. Anterior mullerian hormone(AMH) > 1.0 ng/ML 4. Antral follicle count (AFC) > 8 5. Body mass index (BMI) < 35 mt2/kg 6. Estradiol (E2) < 50PG/ML Exclusion Criteria: 1. Women with one ovary. 2. Women in whom both ovaries are not seen on ultrasonography. 3. Women with too small uterine cavity. 4. Women with history of recurrent pregnancy loss 5. Women with systemic lupus erythematosus (SLE), Nephrotic syndrome, Meyer Rocky Tansky Kustner Hammer(MRKH) syndrome,etc. 6. Human immunodeficiency virus (HIV) I and II positive women.
|Official title||Assessment of Implantation Potential of Embryos Cultured by Time-lapse Technology (Embryoscope) Before Transfer in In-vitro Fertilization (IVF) / Intracytoplasmic Sperm Injection (ICSI) Cycles: A Randomized Control Study.|
|Principal investigator||Hrishikesh D Pai, M.D.|
|Description||1. There will be two arms of the study. The Study arm in which embryos of patients will be cultured in the Embryoscope. The control arm in which the embryos of patients will be cultured under conventional conditions. 2. Embryos to be transferred will be identified by the Embryoviewer in the Study arm and the ones in the control arm will be identified by established subjective morphological criteria. 3. Embryos with definite implantation potential will be transferred in both arms. 4. Embryos not transferred will be frozen and/or discarded in both arms.|
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