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.
Overview
- Phase
- Phase 4
- Intervention
- recombinant Follicle Stimulating Hormone (rFSH)
- Conditions
- Embryo/Fetus Death
- Sponsor
- Bloom IVF and Fertility Centre
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- No.of top quality embryos produced in both the arms, study arm and control arm.
- Last Updated
- 13 years ago
Overview
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
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.
Investigators
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.
Arms & Interventions
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.
Intervention: recombinant Follicle Stimulating Hormone (rFSH)
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.
Intervention: recombinant Follicle Stimulating Hormone (rFSH)
Outcomes
Primary Outcomes
No.of top quality embryos produced in both the arms, study arm and control arm.
Time Frame: 2 weeks
1. 4-cell embryos on day 2 of fertilization in both,Study arm and Control arm. 2. 8-cell embryos on day 3 of fertilization in both Study arm and Control arm. 3. Blastocyst embryos on day 5 or day 6 of fertilization in both Study arm and Control arm.
Secondary Outcomes
- Clinical pregnancy(6 weeks after embryo transfer (ET))