search
Back to results

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

Primary Purpose

Embryo/Fetus Death, Blastocyst Disintegration, Aneuploidy

Status
Unknown status
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
recombinant Follicle Stimulating Hormone (rFSH)
Sponsored by
Bloom IVF and Fertility Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Embryo/Fetus Death focused on measuring Time-lapse monitoring of embryos., Embryoscope, IVF-ET/ICSI, Cetrorelix, Gonal-F

Eligibility Criteria

21 Years - 39 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Lilavati Hospital and Research Center, IVF department

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Study Arm

Control Arm

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

No.of top quality embryos produced in both the arms, study arm and control arm.
4-cell embryos on day 2 of fertilization in both,Study arm and Control arm. 8-cell embryos on day 3 of fertilization in both Study arm and Control arm. Blastocyst embryos on day 5 or day 6 of fertilization in both Study arm and Control arm.

Secondary Outcome Measures

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

Full Information

First Posted
December 26, 2012
Last Updated
January 3, 2013
Sponsor
Bloom IVF and Fertility Centre
Collaborators
Padmashree Dr. D. Y. Patil Medical College
search

1. Study Identification

Unique Protocol Identification Number
NCT01760278
Brief Title
Assessment of Implantation Potential of Embryos by Time-lapse Technology
Acronym
Embryoscope
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.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Unknown status
Study Start Date
December 2012 (undefined)
Primary Completion Date
March 2013 (Anticipated)
Study Completion Date
April 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bloom IVF and Fertility Centre
Collaborators
Padmashree Dr. D. Y. Patil Medical College

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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. The 3D images thus produced,are analysed with the help of Embryoviewer, a part of the Embryoscope,through latest software. Embryoviewer also identifies embryos for transfer, freezing and to be discarded.
Detailed Description
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. 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. Embryos with definite implantation potential will be transferred in both arms. Embryos not transferred will be frozen and/or discarded in both arms.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Embryo/Fetus Death, Blastocyst Disintegration, Aneuploidy, Complication of Implant, Chemical Pregnancy
Keywords
Time-lapse monitoring of embryos., Embryoscope, IVF-ET/ICSI, Cetrorelix, Gonal-F

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study Arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Arm
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
recombinant Follicle Stimulating Hormone (rFSH)
Other Intervention Name(s)
Gonal-F, Progesterone vaginal, Ovitrell 250mcg, Cetrorelix 0.25 mg
Intervention Description
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.
Primary Outcome Measure Information:
Title
No.of top quality embryos produced in both the arms, study arm and control arm.
Description
4-cell embryos on day 2 of fertilization in both,Study arm and Control arm. 8-cell embryos on day 3 of fertilization in both Study arm and Control arm. Blastocyst embryos on day 5 or day 6 of fertilization in both Study arm and Control arm.
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Clinical pregnancy
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.
Time Frame
6 weeks after embryo transfer (ET)
Other Pre-specified Outcome Measures:
Title
No. of mature M2 oocytes obtained
Description
Mature oocyte identified by presence of polar body, fluffy granulosa cells surrounded by corona radiata.
Time Frame
2 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Women of age 21-39 yrs. Basal FSH < 12mIU/ml Anterior mullerian hormone(AMH) > 1.0 ng/ML Antral follicle count (AFC) > 8 Body mass index (BMI) < 35 mt2/kg Estradiol (E2) < 50PG/ML Exclusion Criteria: Women with one ovary. Women in whom both ovaries are not seen on ultrasonography. Women with too small uterine cavity. Women with history of recurrent pregnancy loss Women with systemic lupus erythematosus (SLE), Nephrotic syndrome, Meyer Rocky Tansky Kustner Hammer(MRKH) syndrome,etc. Human immunodeficiency virus (HIV) I and II positive women.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hrishikesh D Pai, M.D.
Organizational Affiliation
Bloom IVF and Fertility Centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Manchi R Bharucha, Ph.D.
Organizational Affiliation
Bloom IVF and Fertility Centre
Official's Role
Study Director
Facility Information:
Facility Name
Lilavati Hospital and Research Center, IVF department
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400050
Country
India

12. IPD Sharing Statement

Citations:
PubMed Identifier
18765009
Citation
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. doi: 10.1016/s1472-6483(10)60222-2.
Results Reference
result

Learn more about this trial

Assessment of Implantation Potential of Embryos by Time-lapse Technology

We'll reach out to this number within 24 hrs