Assessment of Implantation Potential of Embryos by Time-lapse Technology

Brief Title

Assessment of Implantation Potential of Embryos by Time-lapse Technology

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.

Brief 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.
    

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 Phase

Phase 4

Study Type

Interventional


Primary Outcome

No.of top quality embryos produced in both the arms, study arm and control arm.

Secondary Outcome

 Clinical pregnancy

Condition

Embryo/Fetus Death

Intervention

recombinant Follicle Stimulating Hormone (rFSH)

Study Arms / Comparison Groups

 Study 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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

200

Start Date

December 2012

Completion Date

April 2013

Primary Completion Date

March 2013

Eligibility 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.
      

Gender

Female

Ages

21 Years - 39 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Hrishikesh D Pai, M.D., , 

Location Countries

India

Location Countries

India

Administrative Informations


NCT ID

NCT01760278

Organization ID

Time-lapse monitoring

Secondary IDs

Study of embryo morphokinetics

Responsible Party

Sponsor

Study Sponsor

Bloom IVF and Fertility Centre

Collaborators

 Padmashree Dr. D. Y. Patil Medical College

Study Sponsor

Hrishikesh D Pai, M.D., Principal Investigator, Bloom IVF and Fertility Centre


Verification Date

January 2013