Lower Gonadotropin doses.

Data supporting this claim is primarily from three prospective randomized control trials In total, the three trials included 600 patients. Link to publications

Table. Cumulative FSH doses (IU) administered during ovarian stimulation cycles. (n) is the number of patients in the respective study arms.

The average total gonadotropin dose during the entire cycle administered to Opt-IVF patients in each trial was significantly lower than the doses administered to patients in the control arms.

Type of Benefits – a reduction in dosage can be expected to reduce side effects associated with a drug. Additionally, in situations where the cost of medications represents a constraint, the lower dose requirements may increase availability of IVF to patients.

More Mii oocytes.

Using Opt-IVF to guide gonadotropin dosing during an ovarian stimulation cycle in an antagonist protocol results in a higher number of mature (Mii) oocytes when compared to standard clinical practice.

Table. Average number of Mii oocytes obtained in patients in each arm of the trial

RCT-1 showed a trend towards more Mii oocytes on average, but this was not statistically significant. RCT-2 and RCT-3 both showed a statistically significant increase in the average number of mature (Mii) oocytes harvested. RCT-3 had a much larger number of patients (392) than RCT-2 (115 patients), while RCT-1 was the smallest of the three (93 patients)

Type of benefit. The proximate goal of a controlled ovarian stimulation cycle is to collect mature oocytes for subsequent in vitro fertilization and implantation. The Opt-IVF algorithm attempts to maximize the number of Mii oocytes. Increasing the number of Mii oocytes harvested is not a clinical endpoint in and of itself. However, increasing the numbers of Mii oocytes harvested allows more to be fertilized in vitro and thus indirectly improves the odds of success at each subsequent stage.

Higher numbers of good day 5 blastocysts

Using Opt-IVF to guide gonadotropin dosing during an ovarian stimulation cycle in an antagonist protocol results in a higher number of day 5 good blastocysts following fertilization and embryo growth in vitro.

Table. Average number of day 5 good quality blastocysts obtained.

Embryo grading of day 5 blastocysts was performed according to Gardner’s embryo grading system. In both trials, patients in the Opt-IV arm had significantly more good quality embryos than patients in the control arms.

RCT-1 used a composite of day 3 good quality embryos and day 5 good blastocysts as the outcome measure, thus the results cannot be compared directly with RCT-2 and RCT-3. A statistically significant increase in good quality embryos was seen in this trial as well. Type of benefit

Development of high-quality blastocysts, that can be frozen for subsequent embryo transfer, represents an end point for a controlled ovarian stimulation cycle. An increase in the number of high-quality day 5 blastocysts is clinically significant, not only because it allows multiple attempts at transfer after a single stimulation cycle.

A higher proportion of patients had successful outcomes.

The magnitude of this benefit was studied in RCT-2 (Link). Whereas at least one Mii oocyte was obtained in most patients in both arms, a much higher proportion of patients had at least 1 good day 5 blastocyst obtained, and the proportions of patients with multiple good blastocysts was also higher.

Using Opt-IVF to guide gonadotropin dosing during an ovarian stimulation cycle in antagonist protocols results in higher clinical pregnancy rates.

Clinical pregnancy is defined by visualizing at least one gestational sac by transvaginal ultrasonography and by the detection of cardiac activity.

Table. Number of patients with clinical pregnancy after first embryo transfer.

Type of benefit – Clinical pregnancy is a significant outcome and our data shows that using the Opt-IVF clinical decision support tool led to a significantly higher clinical pregnancy rate in each trial.

Use of Opt-IVF eliminates the need for ultrasound or blood testing after day 5 of the ovarian stimulation cycle to guide dosing of FSH. As the dose for all remaining days of the cycle is provided on day 5 by the Opt-IVF clinical decision support tool, there is no need for additional testing.

In all three RCT, 100% of the patients in the Opt-IVF arms were dosed with gonadotropins as recommended by the Opt-IVF clinical decision support tool, and the in no case did the treating clinical investigators override the Opt-IVF recommendation, although study protocols allowed them to do so.

Using Opt-IVF to guide gonadotropin doses in expected poor responders yields superior outcomes

Certain patient characteristics predict lower success rates during IVF. These include poor responders. RCT-1 and RCT- 3 had sufficient data to assess the effectiveness of Opt-IVF in such patients. While our clinical trials were not designed to assess effectiveness of Opt-IVF in this subgroup of patients, data from such patients is available.

Table – Outcomes in expected poor responders in clinical trials.

On all relevant metrics, poor responders had better outcomes when Opt-IVF was used to guide gonadotropin dosages during ovarian stimulation cycles.

Using Opt-IVF to guide gonadotropin doses in patients with PCOS yields superior outcomes

Certain patient characteristics predict lower success rates during IVF. These include patients with polycystic ovarian syndrome (PCOS). PCOS is common and is often associated with infertility. RCT-1 and RCT- 3 had sufficient data to assess the effectiveness of Opt-IVF in such patients. While our clinical trials were not designed to assess effectiveness of Opt-IVF in this subgroup of patients, data from such patients is available.

Table. Outcomes in PCOS patients

RCT-1 – a composite of day 3 good quality embryos and day 5 good blastocysts,

RCT-3 -day 5 good quality blastocysts

On all metrics, other than Mii oocytes in RCT-1, patients with PCOS that received gonadotropin dosages guided by Opt-IVF had better outcomes.

Using Opt-IVF to guide gonadotropin doses in older patients yields superior outcomes

Certain patient characteristics predict lower success rates during IVF. These include older patients (age>35 years). While our clinical trials conducted were not designed to assess effectiveness of Opt-IVF in this subgroup of patients, data for clinical pregnancy rates is available.

Table. Clinical Pregnancy rates after first embryo transfer.

Although older patients in the Opt-IVF arms had lower clinical pregnancy rates than younger patients, as expected, the clinical pregnancy rates were higher in the Opt-IVF arms than in the control arms.