» Articles » PMID: 33267959

Individualized Ovarian Stimulation for In vitro Fertilization: a Multicenter, Open Label, Exploratory Study with a Mixed Protocol of Follitropin Delta and Highly Purified Human Menopausal Gonadotropin

Overview
Journal Fertil Steril
Date 2020 Dec 3
PMID 33267959
Citations 6
Authors
Affiliations
Soon will be listed here.
Abstract

Objective: To evaluate the safety profile and the number of usable blastocysts on day 5 and on day 6 after treatment with an individualized dosing regimen of a follitropin delta and highly purified human menopausal gonadotropin (HP-hMG) for controlled ovarian stimulation.

Design: Multicenter, open label, exploratory study.

Setting: Reproductive medicine clinics.

Patient(s): A total of 110 patients (aged 18-40 years).

Intervention(s): Follitropin delta coadministered with HP-hMG, with follitropin delta dose fixed according to an established algorithm and HP-hMG dose at 75 IU when the follitropin delta starting dosage was <12 μg; 150 IU when follitropin delta dosage was 12 μg and weight <100 kg, and 225 IU when follitropin delta dosage was 12 μg and weight ≥100 kg (dosage adjustments confined to HP-hMG only).

Main Outcome Measure(s): Mean number of good-quality blastocysts obtained at day 5 and day 6 as well as the proportion of women with ovarian hyperstimulation syndrome (OHSS).

Result(s): A cohort study was compared with the follitropin delta group from the Evidence-based Stimulation Trial with Human Recombinant Follicle-Stimulating Hormone in Europe and Rest of World 1 (ESTHER-1) study. Even when stratified by age, a statistically significantly higher mean in the number of oocytes retrieved and number of good-quality blastocysts was observed in this study compared with the ESTHER-1 trial in which follitropin delta was used alone. The rate of patients triggered with a gonadotropin-releasing hormone agonist was statistically significantly higher in our Menopur and Rekovelle Combined Study (MARCS) cohort (43%) when compared with the rates reported in the follitropin delta cohort in the ESTHER-1 study (2.3%). Incidence of any grade of OHSS was 9.3% in the present study compared to 2.6% in follitropin delta group from ESTHER-1 trial. No cases of moderate or severe OHSS were observed in our study compared with 1.4% in the follitropin delta group of ESTHER-1.

Conclusion(s): Optimizing the ovarian response during in vitro fertilization employing a mixed protocol of individualized dosing of follitropin delta and HP-hMG resulted in a statistically significant number of usable blastocysts on days 5 and 6 with an increased risk of mild OHSS, which did not require medical intervention or hospitalization.

Clinical Trial Registration Number: NCT03483545.

Citing Articles

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

Doroftei B, Ilie O, Dabuleanu A, Armeanu T, Maftei R J Assist Reprod Genet. 2024; 41(7):1851-1861.

PMID: 38809330 PMC: 11263530. DOI: 10.1007/s10815-024-03146-1.


Efficacy and safety of follitropin delta versus follitropin alpha/beta in infertility treatment: A systematic review and meta-analysis.

Komiya S, Watanabe J, Terayama T, Kamijo K, Okada H Reprod Med Biol. 2024; 23(1):e12573.

PMID: 38528991 PMC: 10961712. DOI: 10.1002/rmb2.12573.


Efficacy and safety of follitropin delta for ovarian stimulation in vitro fertilization/ intracytoplasmic sperm injection cycles: a systematic review with meta-analysis.

Palomba S, Caserta D, Levi-Setti P, Busnelli A J Ovarian Res. 2024; 17(1):60.

PMID: 38486276 PMC: 10938807. DOI: 10.1186/s13048-024-01372-w.


Follitropin delta combined with menotropin in patients at risk for poor ovarian response during in vitro fertilization cycles: a prospective controlled clinical study.

Duarte-Filho O, Miyadahira E, Matsumoto L, Yamakami L, Tomioka R, Podgaec S Reprod Biol Endocrinol. 2024; 22(1):7.

PMID: 38166856 PMC: 10759374. DOI: 10.1186/s12958-023-01172-9.


Inadvertent Administration of 72 µg of Follitropin-Δ for Three Consecutive Days Does Not Appear to Be Dangerous for Poor Responders: A Case Series.

Baldini G, Mastrorocco A, Sciorio R, Palini S, Dellino M, Cascardi E J Clin Med. 2023; 12(16).

PMID: 37629245 PMC: 10456029. DOI: 10.3390/jcm12165202.