CTRI/2018/11/016300
Suspended
未知
A comparative study to evaluate the performance of gripper-based holding(referred asRoboICSI�®) in intracytoplasmicsperm injection (ICSI) technique with the existingmicropipette-based aspiration technique.
SPOVUM TECHNOLOGIES PRIVATE LIMITED0 sites0 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- SPOVUM TECHNOLOGIES PRIVATE LIMITED
- Status
- Suspended
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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 \<10 IU/L and Estradiol levels \<50 pg /mL at day 2\-3 of the prescreening menstrual cycle and on the day 2\- 3 of screening menstrual cycle.
- •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 ââ?°Â¤10 mm in diameter at prescreening.
- •7\. Subject has a body mass index ââ?°Â¥18\.5 and \<30 kg/m2\.
- •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
- •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 \<5 oocytes) in the previous ART cycle.
- •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.
Outcomes
Primary Outcomes
Not specified
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