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

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.

Study Overview

• Status: Unknown
• Conditions: Aneuploidy; Blastocyst Disintegration; Embryo/Fetus Death; Complication of Implant; Chemical Pregnancy
• Intervention / Treatment: Drug: recombinant Follicle Stimulating Hormone (rFSH)

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: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 4

Contacts and Locations

Study Locations

• India
  • Maharashtra
    • Mumbai, Maharashtra, India, 400050
      • Lilavati Hospital and Research Center, IVF department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 39 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 weeks after embryo transfer (ET)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
No. of mature M2 oocytes obtained	Mature oocyte identified by presence of polar body, fluffy granulosa cells surrounded by corona radiata.	2 weeks

Collaborators and Investigators

• Sponsor: Bloom IVF and Fertility Centre
• Collaborators: 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

Publications and helpful links

General 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. doi: 10.1016/s1472-6483(10)60222-2.

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (ANTICIPATED): March 1, 2013
• Study Completion (ANTICIPATED): April 1, 2013

Study Registration Dates

• First Submitted: December 26, 2012
• First Submitted That Met QC Criteria: January 3, 2013
• First Posted (ESTIMATE): January 4, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): January 4, 2013
• Last Update Submitted That Met QC Criteria: January 3, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: Cetrorelix; Gonal-F; Time-lapse monitoring of embryos.; Embryoscope; IVF-ET/ICSI
• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Death; Chromosome Aberrations; Abortion, Spontaneous; Aneuploidy; Embryo Loss; Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Reproductive Control Agents; Fertility Agents, Female; Fertility Agents; Progestins; Follicle Stimulating Hormone; Hormones; Cetrorelix; Progesterone
• Other Study ID Numbers: Time-lapse monitoring; Study of embryo morphokinetics (OTHER: Bloom IVFand Fertility Centre)