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Assessment of Implantation Potential of Embryos by Time-lapse Technology (Embryoscope)

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ClinicalTrials.gov Identifier: NCT01760278
Recruitment Status : Unknown
Verified January 2013 by Bloom IVF and Fertility Centre.
Recruitment status was:  Active, not recruiting
First Posted : January 4, 2013
Last Update Posted : January 4, 2013
Sponsor:
Collaborator:
Padmashree Dr. D. Y. Patil Medical College
Information provided by (Responsible Party):
Bloom IVF and Fertility Centre

Tracking Information
First Submitted Date  ICMJE December 26, 2012
First Posted Date  ICMJE January 4, 2013
Last Update Posted Date January 4, 2013
Study Start Date  ICMJE December 2012
Estimated Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 3, 2013)
No.of top quality embryos produced in both the arms, study arm and control arm. [ Time Frame: 2 weeks ]
  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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 3, 2013)
Clinical pregnancy [ Time Frame: 6 weeks after embryo transfer (ET) ]
Clinical pregnancy will be identified by presence of gestational sac(s) and fetal heart-beat by transvaginal ultrasonography in sixth week after embryo transfer.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 3, 2013)
No. of mature M2 oocytes obtained [ Time Frame: 2 weeks ]
Mature oocyte identified by presence of polar body, fluffy granulosa cells surrounded by corona radiata.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Assessment of Implantation Potential of Embryos by Time-lapse Technology
Official Title  ICMJE 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.
Brief Summary
  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.
Detailed 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Embryo/Fetus Death
  • Blastocyst Disintegration
  • Aneuploidy
  • Complication of Implant
  • Chemical Pregnancy
Intervention  ICMJE Drug: recombinant Follicle Stimulating Hormone (rFSH)

There are two arms of the study. The Study arm and the Control arm. In each arm, subjects, after randomization, will be stimulated with rFSH 225IU/day.

On day 6, Cetrorelix 0.25mg/day to be added till the day of Ovitrell. Thereafter, ovum pick-up and embryo transfer to be done. Six weeks after transfer clinical pregnancy identified which will be the end-point of the study.

Other Names:
  • Gonal-F
  • Progesterone vaginal
  • Ovitrell 250mcg
  • Cetrorelix 0.25 mg
Study Arms  ICMJE
  • 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.
    Intervention: Drug: recombinant Follicle Stimulating Hormone (rFSH)
  • 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.
    Intervention: Drug: recombinant Follicle Stimulating Hormone (rFSH)
Publications * Lemmen 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 3, 2013)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2013
Estimated Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 21 Years to 39 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01760278
Other Study ID Numbers  ICMJE Time-lapse monitoring
Study of embryo morphokinetics ( Other Identifier: Bloom IVFand Fertility Centre )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bloom IVF and Fertility Centre
Study Sponsor  ICMJE Bloom IVF and Fertility Centre
Collaborators  ICMJE Padmashree Dr. D. Y. Patil Medical College
Investigators  ICMJE
Principal Investigator: Hrishikesh D Pai, M.D. Bloom IVF and Fertility Centre
Study Director: Manchi R Bharucha, Ph.D. Bloom IVF and Fertility Centre
PRS Account Bloom IVF and Fertility Centre
Verification Date January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP