IVF
Conditions
Brief summary
Aim: A Clinical trial to determine the effectiveness of using the proposed decision support tool (OPTIVF) for each patient's customized optimal drug dosage profile. This will be a two-arm (in the ratio 1:3) clinical trial involving more than 80 participants; one arm will undergo superovulation using dosages predicted by the decision support tool while the other arm has undergone current standard treatment. The investigators will compare the outcomes of the two groups of participants in terms of the numbers and percentage of mature follicles retrieved at the end of each cycle, total FSH and HMG dosages used, and the number of required testing days for that cycle. The participants considered will include all ages, with and without PCOS, and low, average, and high responders.
Detailed description
This is a multi-site cohort with two arms (one arm for the intervention and one arm for the traditional approach) clinical trial involving more than 70 participants. The population size for the clinical trial was kept small because retrospective data for 170 patients is already collected each for comparing the two arms of the trial. Further, the data for 45 patients is there from the early small clinical trial we conducted in India. The main site for this task is the Akansha Hospital, India, and all the analysis will be carried out at the Stochastic Research site. Dr. Urmila Diwekar will be an investigator from the Stochastic Research Technologies LLC, and Dr. Nayana Patel will be an investigator from Akansha Hospital and Research Institute. In our study, the investigators will be using the participant's age and day three serum day AMH and FSH levels to decide the starting dose for the patient's cycle. The investigators will use the first two days of data collected (Follicular size distribution, estrogen levels) for that paticipant to determine the optimal dosage profile for the entire cycle for that participant with the help of the decision support tool OPT-IVF for this intervention in the clinical trial. Primary and secondary outcomes will be measured.
Interventions
DEVICEOPT-IVF dosage
Dosage predicted for each patient by the decision support tool OPTIVF
Sponsors
Akansha Hospital and Research Institute, India
Stochastic Research Technologies LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Identity of the patient in any form is not provided.
Intervention model description
OPT-IVF is a decision support tool which personalizes and optimizes dosage for each patient for each cycle.
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Women undergoing infertility treatment
Exclusion criteria
* No male participants
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of follicles retrieved | At the end of cycle 1 (each cycle ranges from 10 to 12 days) | follicles retrieved |
| Number of M2s | At the end of cycle 1(each cycle ranges from 10 to 12 days) | Number of M2s retrieved |
| No. of Very Good Embryos | At the end of cycle 1 (each cycle ranges from 10 to 12 days) | Grade A Embryos |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pregnancy | 9 to 12 days after the transfer | Whether pregnancy is resulted or not |
Countries
India
Outcome results
None listed