Aneuploidy, Blastocyst Disintegration, Chemical Pregnancy, Complication of Implant, Embryo/Fetus Death
Conditions
Keywords
Time-lapse monitoring of embryos., Embryoscope, IVF-ET/ICSI, Cetrorelix, Gonal-F
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.
Interventions
DRUGrecombinant 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.
Sponsors
Padmashree Dr. D. Y. Patil Medical College
Bloom IVF and Fertility Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 39 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| No. of mature M2 oocytes obtained | 2 weeks | Mature oocyte identified by presence of polar body, fluffy granulosa cells surrounded by corona radiata. |
Countries
India
Outcome results
None listed