Overview

This trial is active, not recruiting.

Conditions embryo/fetus death, blastocyst disintegration, aneuploidy, complication of implant, chemical pregnancy
Treatment recombinant follicle stimulating hormone (rfsh)
Phase phase 4
Sponsor Bloom IVF and Fertility Centre
Collaborator Padmashree Dr. D. Y. Patil Medical College
Start date December 2012
End date March 2013
Trial size 200 participants
Trial identifier NCT01760278, Study of embryo morphokinetics, Time-lapse monitoring

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.
recombinant follicle stimulating hormone (rfsh) Gonal-F
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.
(Active Comparator)
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.
recombinant follicle stimulating hormone (rfsh) Gonal-F
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.

Primary Outcomes

Measure
No.of top quality embryos produced in both the arms, study arm and control arm.
time frame: 2 weeks

Secondary Outcomes

Measure
Clinical pregnancy
time frame: 6 weeks after embryo transfer (ET)

Eligibility Criteria

Female participants from 21 years up to 39 years old.

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.

Additional Information

Official title 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.
Principal investigator Hrishikesh D Pai, M.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2013.
Information provided to ClinicalTrials.gov by Bloom IVF and Fertility Centre.