Assessment of Implantation Potential of Embryos by Time-lapse Technology

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2013-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

recombinant Follicle Stimulating Hormone (rFSH)

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

recombinant Follicle Stimulating Hormone (rFSH)

Intervention Type 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.

Interventions

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recombinant Follicle Stimulating Hormone (rFSH)

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.

Intervention Type DRUG

Other Intervention Names

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Gonal-F Progesterone vaginal Ovitrell 250mcg Cetrorelix 0.25 mg

Eligibility Criteria

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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.

Minimum Eligible Age

21 Years

Maximum Eligible Age

39 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes