Table 3 Protocols for clinical trials intercepted about follitropin delta for ovarian stimulation in IVF/ICSI cycles. The search was performed on ClinicalTrials.gov, on clinicaltrialsregister.eu and on the national/international registries included on the WHO platform. Data are reported as detailed on the online register
Registry | Trial ID | Country (the first setting is reported) | Sample size (estimated for ongoing trial) | Study aim | Sponsor/funds | Status | Study start | Study competition (estimated) |
|---|---|---|---|---|---|---|---|---|
ClinicalTrials.gov EU-CTR | NCT01426386 EudraCT number: 2011-000633-36 | Belgium (multicenter) | 265 Caucasian infertile eumenorrheic patients aged between 18 and 37 years, with BMI between 18.5 and 32.0 kg/m2, and without anovulatory PCOS stratified for AMH levels. | To investigate the effects of different doses of follitropin delta in women undergoing controlled stimulation for IVF/ICSI treatment on oocyte retrieved. | Ferring Pharmaceuticals | Completed, with results (published by Arce et al., 2014 [22]) | 2011-09-08 | 2013-03 |
ClinicalTrials.gov EU-CTR | NCT01956110 EudraCT number: 2013-001669-17 | Belgium (multicenter) | 1329 Caucasian infertile eumenorrheic patients aged between 18 and 40 years, basal FSH levels less than 15 UI/l, and BMI between 17.5 and 32.0 kg/m2. | To compare the efficacy and safety of follitropin delta with follitropin alfa having as primary endpoints the ongoing pregnancy and implantation rate in women undergoing ovarian stimulation for IVF/ICSI. | Ferring Pharmaceuticals | Completed, with results (ESTHER-1 TRIAL published by Nyboe Andersen et al., 2017 [15]) | 2013-10 | 2017-01-03 |
ClinicalTrials.gov EU-CTR | NCT01956123 EudraCT number: 2013-001616-30 | Belgium (multicenter) | 513 infertile patients included in a previous trial (NCT01956110) and failed to achieve an ongoing pregnancy but who undergone oocyte retrieval or had cycle cancellation prior to oocyte retrieval due to poor ovarian response or excessive ovarian response, in the previous cycle(s). | To investigate in repeated cycles the immunogenicity of follitropin delta having follitropin alfa as comparator arm. | Ferring Pharmaceuticals | Completed, with results (ESTHER-2 TRIAL published by Bosh et al., 2019 [23]) | 2014-03-26 | 2017-01-03 |
ClinicalTrials.gov | NCT02309671 | Japan | 159 infertile eumenorrheic patients aged between 20 and 39 years without PCOS. | To investigate the effects of different doses of follitropin delta having as comparator arm follitropin alfa in infertile women undergoing IVF/ICSI treatment. | Ferring Pharmaceuticals | Completed, with results (published by Ishihara et al. 2021 – phase 2 trial [25]) | 2014-12 | 2016-09 |
ClinicalTrials.gov | NCT03228680 | Japan (multicenter) | 373 Japanese infertile eumenorrheic patients aged between 20 and 40 years, basal FSH levels less than 15 UI/l, and BMI between17.5 and 32.0 kg/m2. | Non-inferiority study comparing follitropin delta and follitropin beta in terms of number of oocytes retrieved in women undergoing ovarian stimulation for IVF/ICSI. | Ferring Pharmaceuticals | Completed, with results (STORK trial published by Ishihara et al., 2021 [26]) | 2017-07-29 | 2019-07-08 |
ClinicalTrials.gov | NCT03296527 | China (multicenter) | 1011 Asian infertile eumenorrheic patients aged between 20 and 40 years, basal FSH levels less than 15 UI/l, and BMI between 17.5 and 32.0 kg/m2. | To demonstrate non-inferiority of follitropin delta in comparison with follitropin alfa in terms of ongoing pregnancy rate in women undergoing controlled ovarian stimulation for IVF treatment. | Ferring Pharmaceuticals | Completed, with results (GRAPE TRIAL published by Qiao et al., 2021 [24]) | 2017-12-01 | 2020-07-26 |
ClinicalTrials.gov ANZCTR | NCT03393780 Specific number not available | Australia (multicenter) | 1018 infertile patients aged more than 18 years never treated with IVF/ICSI treatments | Observational study aimed to monitor the use in routine clinical practice of follitropin delta in patients who never underwent previous IVF/ICSI treatments. | Ferring Pharmaceuticals | Completed, with results (Blockeel et al., 2022 [39]) | 2018-03-16 | 2020-07-17 |
ClinicalTrials.gov EU-CTR | NCT03564509 EudraCT number: 2017-003810-13 | Belgium (multicenter) | 620 infertile patients aged between 30 and 42 years with AMH levels between 5.0 and 35.0 pmol/L, and without anovulatory PCOS. | To investigate the efficacy of FE 999,302 as add-on treatment to follitropin delta in women undergoing ovarian stimulation for IVF/ICSI in a long GnRH-a protocol, and to assess the safety profile, the potential immunogenicity, and the impact of body weight. | Ferring Pharmaceuticals | Completed, with results (Rainbow trial published by Fernández Sánchez et al., 2022 [21]) | 2018-05-14 | 2020-01-08 |
ClinicalTrials.gov | NCT03738618 | United States (multicenter) | 521 infertile eumenorrheic patients aged between 35 and 42 years, basal FSH levels less than 15 UI/l, and BMI between 17.5 and 38.0 kg/m2. | To investigate the safety and efficacy of follitropin delta in comparison to placebo arm. | Ferring Pharmaceuticals | Completed | 2018-10-29 | 2020-12-21 |
ClinicalTrials.gov | NCT03740737 | United States | 579 infertile eumenorrheic patients aged between 18 and 34 years, basal FSH levels less than 15 UI/l, and BMI between17.5 and 38.0 kg/m2. | To investigate the safety and efficacy of follitropin delta in comparison to placebo arm. | Ferring Pharmaceuticals | Completed | 2018-10-26 | 2020-11-20 |
ClinicalTrials.gov EU-CTR | NCT03809429 EudraCT number: 2017-002783-40 | Austria (multicenter) | 437 patients aged between 18 and 40 years with BMI between17.5 and 38.0 kg/m2 and without elevated markers of ovarian reserve. | To compare the efficacy and safety of follitropin delta for ovarian stimulation in IVF/ICSI cycles down-regulated with long GnRH agonist protocol vs. a short GnRH antagonist protocol. | Ferring Pharmaceuticals | Completed, with results1 | 2019-04-29 | 2022-02-16 |
ClinicalTrials.gov | NCT04150861 | China (multicenter) | 24 Chinese infertile patients eumenorrheic patients aged between 21 and 40 years, with BMI between 18.5 and 25.0 kg/m2, and without PCOS. | Open-label study to investigate the pharmacokinetic, safety and tolerability of follitropin delta in single subcutaneous dose in GnRH-agonist down-regulated IVF cycles. | Ferring Pharmaceuticals | Completed, with results (published by Shao et al., 2023 [27]) | 2019-06-23 | 2019-12-16 |
ClinicalTrials.gov | NCT04654039 | Korea | 600 Korean infertile patients who were prescribed follitropin delta for the first time. | Post-marketing surveillance study for re-examine the safety of follitropin delta to identify potential new adverse events, and to confirm its safety and effectiveness. | Ferring Pharmaceuticals | Recruiting | 2020-10-26 | 2023-10-31 |
ClinicalTrials.gov | NCT04773353 | India (multicenter) | 220 Indian infertile eumenorrheic patients aged between 21 and 40 years, basal FSH levels less than 15 UI/l, and BMI between 17.5 and 32.0 kg/m2. | Non-inferiority study comparing follitropin delta and follitropin alfa in terms of ongoing pregnancy rate in women undergoing ovarian stimulation for IVF/ICSI. | Ferring Pharmaceuticals | Active, not recruiting | 2021-12-03 | 2024-02 |
ClinicalTrials.gov EU-CTR | NCT05263388 EudraCT number: 2021-001785-38 | Austria (multicenter) | 300 infertile eumenorrheic patients aged between 18 and 40 years. | To compare the efficacy of follitropin delta (starting dose of 15 µg daily) in comparison with follitropin alfa (starting dose of 225 IU daily) for ovarian stimulation in IVF/ICSI cycles in terms of oocytes retrieved. | Ferring Pharmaceuticals | Recruiting | 2022-07-10 | 2024-04-15 |
EU-CTR | EudraCT number: 2017-003810-13 | 773 subjects were screened of 619 subjects were exposed to investigational medicinal product (IMP): 515 to FE 999,302 and 104 to placebo. | To investigate the efficacy and safety of FE 999,302 as add-on treatment to follitropin delta in women undergoing ovarian stimulation in a long GnRH-a protocol | Ferring Pharmaceuticals | Completed with results unpublished. | 2019-10-21 | 2020-01-30 | |
ReBec | U1111-1247-3260 | Brasil | 44 (intervention group) vs. 280 (historical control group) infertile eumenorrheic patients aged between 18 and 40 years, basal FSH levels less than 15 UI/l, and BMI between 17.5 and 32.0 kg/m2. | Prospective interventional study with historical control aimed to evaluate the effect of hp-FSH addition at standard staring doses (150 UI daily) in patients who receive follitropin delta. | Ferring Pharmaceuticals | Not yet recruiting | 2020-01-03 | 2020-12-31 |