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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
History of Changes
  Purpose
  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.

Condition Intervention Phase
Embryo/Fetus Death
Blastocyst Disintegration
Aneuploidy
Complication of Implant
Chemical Pregnancy
 Drug: recombinant Follicle Stimulating Hormone (rFSH)
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bloom IVF and Fertility Centre:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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.


Estimated Enrollment: 200
Study Start Date: December 2012
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 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
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.
 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

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.
  Eligibility

Ages Eligible for Study:   21 Years to 39 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01760278

Locations
India
Lilavati Hospital and Research Center, IVF department
Mumbai, Maharashtra, India, 400050
Sponsors and Collaborators
Bloom IVF and Fertility Centre
Padmashree Dr. D. Y. Patil Medical College
Investigators
Principal Investigator: Hrishikesh D Pai, M.D. Bloom IVF and Fertility Centre
Study Director: Manchi R Bharucha, Ph.D. Bloom IVF and Fertility Centre
  More Information

Publications:

Responsible Party: Bloom IVF and Fertility Centre
ClinicalTrials.gov Identifier: NCT01760278     History of Changes
Other Study ID Numbers: Time-lapse monitoring, Study of embryo morphokinetics
Study First Received: December 26, 2012
Last Updated: January 3, 2013
Health Authority: India: Indian Council of Medical Research

Keywords provided by Bloom IVF and Fertility Centre:
Time-lapse monitoring of embryos.
Embryoscope
IVF-ET/ICSI
Cetrorelix
Gonal-F

Additional relevant MeSH terms:
Aneuploidy
Embryo Loss
Fetal Death
Chromosome Aberrations
Pathologic Processes
Abortion, Spontaneous
Pregnancy Complications
Death
Hormones
 Progesterone
Follicle Stimulating Hormone
Cetrorelix
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Progestins
Hormone Antagonists

ClinicalTrials.gov processed this record on June 18, 2013