Assessment of Implantation Potential of Embryos by Time-lapse Technology

Aneuploidy Clinical Trial

— 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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01760278
• Other study ID #: Time-lapse monitoring
• Secondary ID: Study of embryo
• Status: Active, not recruiting
• Phase: Phase 4
• First received: December 26, 2012
• Last updated: January 3, 2013
• Start date: December 2012
• Est. completion date: April 2013

Study information

• Verified date: January 2013
• Source: Bloom IVF and Fertility Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Indian Council of Medical Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: April 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 39 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aneuploidy
• Blastocyst Disintegration
• Chemical Pregnancy
• Complication of Implant
• Embryo Loss
• Embryo/Fetus Death

Intervention

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.

Locations

Country	Name	City	State
India	Lilavati Hospital and Research Center, IVF department	Mumbai	Maharashtra

Sponsors (2)

Lead Sponsor	Collaborator
Bloom IVF and Fertility Centre	Padmashree Dr. D. Y. Patil Medical College

Country where clinical trial is conducted

India, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	No. of mature M2 oocytes obtained	Mature oocyte identified by presence of polar body, fluffy granulosa cells surrounded by corona radiata.	2 weeks	No
Primary	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	No
Secondary	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)	Yes