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Trial · Interventional

Status unknownPhase 4Registry data

Assessment of Implantation Potential of Embryos by Time-lapse Technology

Short name Embryoscope

NCTNCT01760278 (opens ClinicalTrials.gov in a new tab)Other idTime-lapse monitoringOther idStudy of embryo morphokinetics
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Status unknown
Phase
Phase 4
Enrollment
200 participants (estimated)
Sponsor
Bloom IVF and Fertility Centre · Other
Design
Randomized · Open label (no masking)
Countries
1 country

India

Start
Dec 2012
Primary completion
Mar 2013 (estimated)
Completion
Apr 2013 (estimated)
First posted
4 Jan 2013 (estimated)
Last update posted
4 Jan 2013 (estimated)
Conditions
Embryo/Fetus Death · Blastocyst Disintegration · Aneuploidy · Complication of Implant · Chemical Pregnancy

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201220132014
  1. Ph 4

    Embryoscope

    NCT01760278

    Dec 2012 to est. Apr 2013

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • recombinant Follicle Stimulating Hormone (rFSH)Drug

Arms2

  • Experimental

    Study Arm

    Subjects would receive recombinant Follicle Stimulating Hormone (rFSH) by S.C. injection 150 - 225 IU/day for 9 days. The embryos of subjects would be cultured by time-lapse imagery technique (embryoscope) and analysis would be done using patients receive rFSH (Gonembryo viewer equipped with latest software.

  • Active comparator

    Control Arm

    Subjects would receive recombinant Follicle Stimulating Hormone (rFSH) by S.C. injection 150 - 225 IU/day for 9 days. The embryos of subjects would be cultured in conventional culture environment and analysis would be done using established subjective morphological criteria.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. No.of top quality embryos produced in both the arms, study arm and control arm.

    Time frame · 2 weeks

    Registry description

    1. 4-cell embryos on day 2 of fertilization in both,Study arm and Control arm. 2. 8-cell embryos on day 3 of fertilization in both Study arm and Control arm. 3. Blastocyst embryos on day 5 or day 6 of fertilization in both Study arm and Control arm.

Secondary outcomes(1)

  1. Clinical pregnancy

    Time frame · 6 weeks after embryo transfer (ET)

    Registry description

    Clinical pregnancy will be identified by presence of gestational sac(s) and fetal heart-beat by transvaginal ultrasonography in sixth week after embryo transfer.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • ResultLemmen JG, Agerholm I, Ziebe S. Kinetic markers of human embryo quality using time-lapse recordings of IVF/ICSI-fertilized oocytes. Reprod Biomed Online. 2008 Sep;17(3):385-91. doi: 10.1016/s1472-6483(10)60222-2. PMID 18765009

Eligibility

Who could join, as posted.

Sex
Female
Age
from 21 Years up to 39 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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.

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