None listed
Conditions
Interventions
Intervention1: RoboICSI�®: To evaluate the performance of gripper-based holding in intracytoplasmicsperm injection technique.
Control Intervention1: Micropipette based aspiration technique for ICSI:
Sponsors
SPOVUM TECHNOLOGIES PRIVATE LIMITED
Eligibility
Inclusion criteria
Inclusion criteria: 1. Oocyte from donors aged between 23 - 30 years. 2. Recruitment is done according to ICMR Guideline. 3. Subject has FSH level 4. Or Subject has an AMH level more than 1.5ng/mL during the screening menstrual cycle. 5. Evaluate FSH and Estradiol levels or AMH levels. The AMH level determination if chosen will have to be performed only during the prescreening menstrual cycle. 6. Subject has an AFC of 10 or more (sum of both ovaries), each follicle �10 mm in diameter at prescreening. 7. Subject has a body mass index �18.5 and 8. Subject has results of clinical laboratory tests (haematology, blood chemistry, and urinalysis) within normal reference range, or outside the reference range, but not clinically significant as determined by the investigator at screening. 9. Subject agrees to use a barrier contraception technique for the duration of the clinical phase of the study. 10. Subject willing to provide written informed consent for experimental procedure.
Exclusion criteria
Exclusion criteria: 1. Subject with history of any endocrine abnormality, with documented hormone levels outside the reference range, which are clinically relevant, at screening. 2. Subject with only one ovary or ovarian abnormality (including endometrioma >10 mm visible on USG), at screening. 3. Subject with documented severe endometriosis (American Society of Reproductive Medicine stage 3 or stage 4) or hydrosalpinx, at screening. 4. Subject with a history of extrauterine pregnancy within 3 months of screening. 5. Subject with pregnancy detected at the time of screening. 6. Subject with history of poor response to gonadotropin treatment (retrieval of 7. Subject who have tested positive for Human Immunodeficiency Virus, Hepatitis B or Hepatitis C at screening. 8. Subject known to be allergic, hypersensitive, or intolerant to any of the preparations of r-FSH or its excipients/ HP-hMG or its excipients, that will be used in the stimulation. 9. Subject with contraindications to the use of gonadotropins (e.g., tumours, undiagnosed vaginal bleeding, or ovarian cysts) or GnRH antagonists (e.g. hypersensitivity). 10. Subject with a history of epilepsy, thrombophilia, cardiovascular, gastrointestinal, hepatic, renal, pulmonary, auto-immune disease or any active infection/clinically significant systemic disease, requiring treatment which at the investigatorââ?¬•s discretion might interfere with the study. 11. Subject with history of malignancy. 12. Subject who smokes or has stopped smoking within the last 3 months prior to screening. 13. Subject with history of alcohol or drug abuse within 12 months prior to screening. 14. Subject who has received any treatment listed below within 5 half-lives prior to screening: y1Any agent(s) known to affect ovulation (e.g., neuroleptics). 15. Subject who has received an investigational product or has used an invasive investigational medical device within 60 days before the planned first dose of the study drug or is currently enrolled in an investigational study. 16. Subject unwilling to sign the written informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Accuracy of grasping of oocyte will be determined by estimate and comparing the time of immobilization by RoboICSIÃ?® and micropipette-based aspiration process. 2. Turnaround time (TAT) will be calculated and compared for the following parameters for RoboICSIÃ?® and micropipette-based aspiration process. Device setup (installation) time Per-cycle loading and unloading time Time for immobilization (holding the oocyte) Overall time for the injection.Timepoint: Untill recruitment of 10 oocyte donor | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Measure the mortality rate(damage/lysis/death) of oocytes with RoboICSIÃ?® and micropipette-based aspiration process for ICSI technique. 2. Measure fertilization rate and blastocyst conversion rate and compare with RoboICSIÃ?® and micropipette-based aspiration process for ICSI technique. 3. Establish a baseline for mechanical characteristics of an oocyte. Here, the mechanical characteristics shall include bulk-stiffness and deformation pattern.Timepoint: within 3 months | — |
Countries
India
Contacts
Public ContactSubham Dutta
Spovum Technologies Private Limited
Outcome results
None listed