Assessment of Implantation Potential of Embryos by Time-lapse Technology

Bloom IVF and Fertility Centre200 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

200

Conditions

Embryo/Fetus Death Blastocyst Disintegration Aneuploidy

Interventions

recombinant Follicle Stimulating Hormone (rFSH)DRUG

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.

Eligibility

Sex: FEMALEMin age: 21 YearsMax age: 39 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

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.

Time frame: 2 weeks

Secondary Outcomes

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.

Time frame: 6 weeks after embryo transfer (ET)