Assessment of Implantation Potential of Embryos by Time-lapse Technology

Study Overview
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Brief Summary
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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
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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. 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. Embryos with definite implantation potential will be transferred in both arms. Embryos not transferred will be frozen and/or discarded in both arms.

Official Title
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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.

Conditions
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Embryo/Fetus Death, Blastocyst Disintegration, Aneuploidy, Complication of Implant, Chemical Pregnancy

Intervention / Treatment
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* Drug: recombinant Follicle Stimulating Hormone (rFSH)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Arm<br>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)<br>* 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.<br>* Other names: Cetrorelix 0.25 mg;|
| Active Comparator: Control Arm<br>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)<br>* 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.<br>* Other names: Cetrorelix 0.25 mg;|

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Time-lapse monitoring of embryos., Embryoscope, IVF-ET/ICSI, Cetrorelix, Gonal-F