IVF Clinical Trial - An Advanced Decision Support Tool for Personalized

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05377879
Study type	Interventional
Source	Stochastic Research Technologies LLC
Contact
Status	Completed
Phase	N/A
Start date	May 10, 2022
Completion date	July 1, 2022

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05969574` - Is Decreased Ovarian Reserve Related to an Increased Number of Previous Early Miscarriages?
Completed	`NCT04778358` - Higher Dose of Rekovelle in Oocyte Donors	Phase 2
Completed	`NCT04052464` - The Study of the Implantation Window From Endometrial Biopsy With Gene Expression Methods
Completed	`NCT04108039` - Micronized Progesterone vs Gonadotropin-releasing Hormone (GnRH) Antagonist in Freeze-all IVF Cycles.	N/A
Suspended	`NCT04669652` - Evaluating Piezo-ICSI. - The EPI Study.	N/A
Completed	`NCT04524026` - RIOTC: Reducing the Impact of Ovarian Stimulation. Novel Approaches to Luteal Support in IVF-Study 2	Phase 2
Recruiting	`NCT05981898` - Opt-IVF Multi-center Trial 2 Including All Protocols	N/A
Recruiting	`NCT05737381` - Quality of Human Embryos in IVF, Culturing in Differentiated Oxygen	N/A
Recruiting	`NCT04447872` - The LUTEAL Trial: Luteal Stimulation vs. Estrogen Priming Protocol	N/A
Completed	`NCT04425317` - Detection of SARS-CoV-2 in Follicular Fluid and Cumulus-oocyte-complexes in COVID-19 Patients	N/A
Not yet recruiting	`NCT05932082` - The Impact of Myomectomy on IVF Outcomes	N/A
Not yet recruiting	`NCT04283435` - Endometrial Effects of Sildenafil in Frozen-Thawed Cycles in Women With Thin Endometrium	Phase 1
Recruiting	`NCT04654741` - The Rate of Embryo Euploidy in Progestin-primed Ovarian Stimulation Cycles	Phase 4
Completed	`NCT04099784` - Health of Frozen Transferred Versus Fresh Transferred Children
Recruiting	`NCT05788822` - MVA to Improve the Pregnancy Outcome in Aged Infertility Women With Assisted Reproductive Technology	N/A
Completed	`NCT04956848` - Comparing KIDScore™ D5 and iDAScore®. The KiDA Study	N/A
Not yet recruiting	`NCT06048666` - Platelet Rich Plasma on Ovarian Reserve Parameters and Intra Cytoplasmic Sperm Injection Outcomes in Patients With Diminished Ovarian Reserve	Phase 3
Not yet recruiting	`NCT05954962` - Efficacy of Micronized Natural Progesterone vs GnRH Antagonist in the Prevention of LH Peak During Ovarian Stimulation.	Phase 4
Not yet recruiting	`NCT02698488` - Embryo Selection by Metabolomic Profiling of Embryo Culture Medium With Mass Spectroscopy as an Adjunct to Morphology	N/A
Completed	`NCT01385618` - Gene-polymorphisms Relating to Human Subfertility	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

An Advanced Decision Support Tool for Personalized Medicine for IVF Using Modeling and Optimization — OPT-IVF

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms