Clinical trial NCT01760278: 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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Embryo/Fetus Death
Blastocyst Disintegration
Aneuploidy
Complication of Implant
Chemical Pregnancy
Keywords: Time-lapse monitoring of embryos.
Embryoscope
IVF-ET/ICSI
Cetrorelix
Gonal-F
Lead sponsor: Bloom IVF and Fertility Centre
Sponsor class: OTHER
Collaborators: name: Padmashree Dr. D. Y. Patil Medical College
First posted: 2013-01-04
Enrollment: 200
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: No.of top quality embryos produced in both the arms, study arm and control arm.
timeFrame: 2 weeks
Secondary outcomes:
measure: Clinical pregnancy
timeFrame: 6 weeks after embryo transfer (ET)
Other outcomes:
measure: No. of mature M2 oocytes obtained
timeFrame: 2 weeks
Locations:
city: Mumbai
country: India
facility: Lilavati Hospital and Research Center, IVF department
state: Maharashtra
Study officials:
affiliation: Bloom IVF and Fertility Centre
name: Hrishikesh D Pai, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Bloom IVF and Fertility Centre
name: Manchi R Bharucha, Ph.D.
role: STUDY_DIRECTOR
References:
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.