Assessment of Implantation Potential of Embryos by Time-lapse Technology

Phase 4

• Conditions: Embryo/Fetus Death; Blastocyst Disintegration; Aneuploidy; Complication of Implant; Chemical Pregnancy
• Interventions: Drug: recombinant Follicle Stimulating Hormone (rFSH)

• Registration Number: NCT01760278
• Lead Sponsor: Bloom IVF and Fertility Centre

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 Timeline

• Study Start: 2012-12
• Study First Submitted: 2012-12-26
• Status Verified: 2013-01
• Study First Submitted QC: 2013-01-03
• Last Update Submitted: 2013-01-03
• Study First Posted: 2013-01-04
• Last Update Posted: 2013-01-04
• Primary Completion: 2013-03
• Study Completion: 2013-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 200

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study Arm	recombinant Follicle Stimulating Hormone (rFSH)	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.
Control Arm	recombinant Follicle Stimulating Hormone (rFSH)	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.

Primary Outcome Measures

Name	Time	Method
No.of top quality embryos produced in both the arms, study arm and control arm.	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 Outcome Measures

Name	Time	Method
Clinical pregnancy	6 weeks after embryo transfer (ET)	Clinical pregnancy will be identified by presence of gestational sac(s) and fetal heart-beat by transvaginal ultrasonography in sixth week after embryo transfer.

Trial Locations

Locations (1)

Lilavati Hospital and Research Center, IVF department; 🇮🇳 Mumbai, Maharashtra, India