An eight centre, retrospective, clinical practice data analysis of algorithm-based treatment with follitropin delta

Bachmann, Annette; Kissler, Stefan; Laubert, Ina; Mehrle, Patrick; Mempel, Andrea; Reißmann, C.; Sauer, David Sebastian; Tauchert, S.; Bielfeld, Alexandra Petra

doi:10.1016/j.rbmo.2021.12.013

Cited by 5 publications

(6 citation statements)

References 13 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Regardless of the differences in follitropin delta utilization among these studies, PROFILE demonstrates that the follitropin delta dosing algorithm based on bodyweight and AMH levels allows for acceptable ovarian responses and ongoing pregnancy rates that were similar to, or higher than, the rates observed in RCTs with follitropin delta (11,13,18,23). PROFILE is in line with the findings of a recent retrospective study of 360 women undergoing ovarian stimulation with follitropin delta for IVF/ICSI at eight German fertility clinics (24).…”

Section: Discussionsupporting

confidence: 82%

Prospective multicenter non-interventional real-world study to assess the patterns of use, effectiveness and safety of follitropin delta in routine clinical practice (the PROFILE study)

et al. 2022

View full text Add to dashboard Cite

ObjectiveTo observe the real-world utilization patterns, effectiveness and safety profile of follitropin delta in women ≥18 years naïve to ovarian stimulation undergoing in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI).DesignProspective, multinational, multicenter, observational study. All IVF/ICSI treatment protocols were conducted according to routine clinical practice, including undertaking fresh/frozen transfers. Outcomes included use of dosing algorithm, follitropin delta dosing patterns, ovarian response, pregnancy rates and adverse drug reactions (ADRs).ResultsThe first ovarian stimulation cycle using follitropin delta was initiated in 944 women. Mean baseline demographics were: age, 33.5 ± 4.7 years; bodyweight, 67.1 ± 13.6 kg; anti-Müllerian hormone, 20.3 ± 16.1 pmol/L (2.84 ± 2.25 ng/mL). The dosing algorithm was used to calculate the follitropin delta daily starting dose in 893/944 women (94.5%). The mean difference between the calculated and prescribed daily dose was small (0.2 ± 1.40 µg). The mean daily starting follitropin delta dose was 10.4 ± 2.72 µg and the mean total dose administered was 104 µg. Follitropin delta dose adjustments were reported for 57/944 (6.0%) women. The mean number of retrieved oocytes was 10.1 ± 7.03. Ongoing pregnancy at 10–11 weeks was reported for 255 women (27.0% per initiated cycle and 43.1% per fresh transfer [n=592]). Cumulative ongoing pregnancy rate after fresh and/or frozen transfer was 36.4% (344/944). Four women discontinued follitropin delta due to ADRs. Ovarian hyperstimulation syndrome (OHSS) was the most frequently reported ADR (n=37 [3.9%]); most cases of OHSS were of mild or moderate intensity (n=30 [3.2%]).ConclusionsThis large real-world study of follitropin delta utilization patterns confirms its good pregnancy rates while minimizing OHSS risk during first ovarian stimulation cycle.

show abstract

Section: Discussionsupporting

confidence: 82%

Prospective multicenter non-interventional real-world study to assess the patterns of use, effectiveness and safety of follitropin delta in routine clinical practice (the PROFILE study)

et al. 2022

View full text Add to dashboard Cite

show abstract

“…Considering the low immunogenicity among women undergoing multiple stimulation cycles [35], the post hoc analyses emphasize a similar number of oocytes yielded and retrieved [33,35,37], irrespective of ovarian reserve, which interestingly was subsequently contradicted on further examinations [36]. Regardless of the reported mean retrieval of > 10 oocytes [38][39][40] except in one instance [41] and that > 40% achieved the established optimal range between 8 and 14 oocytes [38,40,41], the pregnancy…”

Section: Discussionmentioning

confidence: 98%

“…outcomes did not reveal significant discrepancies between the groups, neither cumulative or per fresh ET [38][39][40][41][42].…”

Section: Nsmentioning

confidence: 99%

The pregnancy outcomes among women receiving individualized algorithm dosing with follitropin delta: a systematic review of randomized controlled trials

Doroftei,

Ilie,

Dabuleanu

et al. 2024

J Assist Reprod Genet

View full text Add to dashboard Cite

Purpose To investigate whether the ovarian stimulation with follitropin delta in an individualized algorithm-based manner is inferior to recombinant human-follicle stimulating’s follitropin alfa or follitropin beta conventional dosing regarding a series of established primary endpoints. Methods We conducted a registered systematic review (CRD42024512792) on PubMed-MEDLINE, Web of Science™, Cochrane Database of Systematic Reviews, and Scopus. Our search was designed to cover all relevant literature, particularly randomized controlled trials. We critically and comparatively analyzed the outcomes for each primary endpoint based on the intervention, reflected by the positive βhCG test, clinical pregnancy, vital pregnancy, ongoing pregnancy, live birth, live birth at 4 weeks, and multiple pregnancies. Results Six randomized controlled trials were included in the quality assessment as priority manuscripts, revealing an 83.3% low risk of bias. Follitropin delta led to non-significant differences in each parameter of interest from positive βhCG test (691; 53.44% vs. 602; 46.55%), ongoing pregnancies (603; 53.79% vs. 518; 46.20%), clinical and vital pregnancies (1,073; 52.80% vs. 959; 47.19%), to live birth and at 4 weeks (595; 54.14% vs. 504; 45.85%) with only 2 losses, and even multiple pregnancies (8; 66.66% vs. 4; 33.33%). However, follitropin delta was well-tolerated among hypo- and hyper-responders without significant risk of ovarian hyperstimulation syndrome and/or preventive interventions in contrast with follitropin alfa or follitropin beta. Conclusion The personalized individualized-based algorithm dosing with follitropin delta is non-inferior to conventional follitropin alfa or follitropin beta. It is as effective in promoting a similar response in women without significant comparable adverse effects.

show abstract

“…Only one computer decision support system encompasses the whole stimulation cycle with day-to-day decisions, but exclusively for IVF controlled hyperstimulation [10]. The few other algorithm-based treatments ever published take into account only one of two specific steps of the stimulation cycle and quite exclusively for IVF purposes: the starting dose [7][8][9][10][11] or the criteria for ovulation triggering [12,13]. To date, StimXpert represents the only stimulation software available assuming both 1 -the entire treatment cycle, and 2 -all validated protocols, from mono-follicular classic stimulation to multi-follicular controlled hyperstimulation.…”

Section: What About Other Algorithm-based Systems?mentioning

confidence: 99%

Artificial Intelligence for Ovarian Stimulation

Emperaire¹,

Eldridge²

2023

IVF Technologies and Infertility - Current Practices and New Perspectives

View full text Add to dashboard Cite

Ovarian stimulation, the basis of treatment strategies for infertility, from anovulation to in vitro fertilization, is a highly efficient therapeutic procedure. The stimulation should ensure a complete development of the follicle(s) along with maturation of the oocyte(s), all without risking hyperstimulation and multiple pregnancies. For these reasons, a stimulation protocol should be personalized, and its evolution must be continually scrutinized using measures of both blood hormone levels and ovarian responses by ultrasound. Essentially all of the stimulation algorithms proposed to date focus only on determination of the starting dose of gonadotropin. But ovarian stimulation should be continually monitored until the final decision is made to trigger or to abort the cycle. This decision can be achieved through use of an experience-based computer software system that monitors menstrual cycles through a beginning pregnancy. This software (StimXpert®) should work effectively with a classical stimulation as well as a controlled hyperstimulation for IVF. It may also be modified from experience-based to evidence-based programming through progressive learning.

show abstract

An eight centre, retrospective, clinical practice data analysis of algorithm-based treatment with follitropin delta

Cited by 5 publications

References 13 publications

Prospective multicenter non-interventional real-world study to assess the patterns of use, effectiveness and safety of follitropin delta in routine clinical practice (the PROFILE study)

Prospective multicenter non-interventional real-world study to assess the patterns of use, effectiveness and safety of follitropin delta in routine clinical practice (the PROFILE study)

The pregnancy outcomes among women receiving individualized algorithm dosing with follitropin delta: a systematic review of randomized controlled trials

Artificial Intelligence for Ovarian Stimulation

Contact Info

Product

Resources

About