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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Padmashree Dr. D. Y. Patil Medical College
Information provided by (Responsible Party):
Bloom IVF and Fertility Centre
ClinicalTrials.gov Identifier:
NCT01760278
First received: December 26, 2012
Last updated: January 3, 2013
Last verified: January 2013

December 26, 2012
January 3, 2013
December 2012
March 2013   (final data collection date for primary outcome measure)
No.of top quality embryos produced in both the arms, study arm and control arm. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  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.
Same as current
Complete list of historical versions of study NCT01760278 on ClinicalTrials.gov Archive Site
Clinical pregnancy [ Time Frame: 6 weeks after embryo transfer (ET) ] [ Designated as safety issue: Yes ]
Clinical pregnancy will be identified by presence of gestational sac(s) and fetal heart-beat by transvaginal ultrasonography in sixth week after embryo transfer.
Same as current
No. of mature M2 oocytes obtained [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Mature oocyte identified by presence of polar body, fluffy granulosa cells surrounded by corona radiata.
Same as current
 
Assessment of Implantation Potential of Embryos by Time-lapse Technology
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.
  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.
  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.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Embryo/Fetus Death
  • Blastocyst Disintegration
  • Aneuploidy
  • Complication of Implant
  • Chemical Pregnancy
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
  • 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)
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.
 
Active, not recruiting
200
April 2013
March 2013   (final data collection date for primary outcome measure)

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.
Female
21 Years to 39 Years
Yes
Contact information is only displayed when the study is recruiting subjects
India
 
NCT01760278
Time-lapse monitoring, Study of embryo morphokinetics
Yes
Bloom IVF and Fertility Centre
Bloom IVF and Fertility Centre
Padmashree Dr. D. Y. Patil Medical College
Principal Investigator: Hrishikesh D Pai, M.D. Bloom IVF and Fertility Centre
Study Director: Manchi R Bharucha, Ph.D. Bloom IVF and Fertility Centre
Bloom IVF and Fertility Centre
January 2013

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