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Cumulative Pregnancy Rate With Lower and Higher Gonadotropin Dose During IVF Among Poor Responders
NA trial testing Follitropin Alfa in Infertility in 190 participants. Completed in 20 July 2023.
| Lead sponsor | Peter Kovacs MD |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 190 |
| Start date | 2 December 2021 |
| Primary completion | 20 July 2023 |
| Estimated completion | 20 July 2023 |
| Sites | 1 location across Hungary |
Peter Kovacs MD
Adults 18 to 42, female only, with Infertility or Ovarian Dysfunction. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
an ultrasound confirmation of an intrauterine gestational sac with an embryo with detectable heartbeat in it after the fresh + if available frozen embryo transfer treatments
| Group | Value | 95% CI |
|---|---|---|
| Lower Gonadotropin Dose Stimulation | 27 | |
| Higher Gonadotropin Dose Stimulation | 17 |
delivery of a viable newborn after 24 weeks gestation
| Group | Value | 95% CI |
|---|---|---|
| Lower Gonadotropin Dose Stimulation | 15 | |
| Higher Gonadotropin Dose Stimulation | 10 |
Cumulative live birth: delivery of a viable newborn after 24 weeks gestation after the fresh embryo transfer or if it is unsuccessful but surplus embryos were frozen then after any of the subsequent frozen embryo transfer cycles. All these transfers (fresh and frozen) are the result of a single stimulation. If a live birth is reached during the fresh or any of the subsequent frozen transfers from the same stimulation then it is considered a positive outcome; if the fresh transfer or any of the subsequent frozen transfers from the same stimulation do not result in a live birth it is considered
| Group | Value | 95% CI |
|---|---|---|
| Lower Gonadotropin Dose Stimulation | 17 | |
| Higher Gonadotropin Dose Stimulation | 13 |
Controlled ovarian hyperstimulation (COH) is an important step during in vitro fertilization (IVF). Its aim optimally is to recruit 10-15 oocytes. When deciding on the actual treatment, different stimulation protocols, various stimulating agents and wide range of gonadotropin dose can one choose from. Prior to the decision on the actual stimulation protocol and gonadotropin (Gn) dose the patient's expected response to stimulation is assessed primarily using ovarian reserve markers. Most medications used during stimulation exert their effect in a dose-dependent manner hence with a higher Gn dose one would expect a better response, more oocytes. More oocytes could translate into more embryos and potentially a higher pregnancy rate. The currently available evidence however does not support this practice as randomized controlled trials (RCT) have failed to show that the use of higher Gn dose results in higher pregnancy, live-birth rates. These studies however identified patients based on different criteria, compared different stimulation protocols and various Gn doses. There are only two RCTs that compared cumulative live birth rates (fresh + frozen embryo transfers) and they identified poor responders based on different criteria and used different drug regimens. Therefore, the aim of our study is to compare cumulative IVF clinical pregnancy rates using a lower and a higher gonadotropin dose among poor responders identified based on universally accepted criteria.
3 peer-reviewed publications reference this trial (live from Europe PMC):
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