Assessment of Implantation Potential of Embryos by Time-lapse Technology (Embryoscope)

Bloom IVF and Fertility Centre

Status and phase: Unknown; Phase 4

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

Treatments: Drug: recombinant Follicle Stimulating Hormone (rFSH)

Study type: Interventional

Funder types: Other

Identifiers

NCT01760278

Study of embryo morphokinetics (Other Identifier)

Time-lapse monitoring

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: Female

Ages: 21 to 39 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Study Arm

Experimental group

Description:

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.

Treatment:

Drug: recombinant Follicle Stimulating Hormone (rFSH)

Control Arm

Active Comparator group

Description:

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.

Treatment:

Drug: recombinant Follicle Stimulating Hormone (rFSH)