A controlled, assessor-blind, parallel groups, multicentre, multinational trial evaluating the immunogenicity of FE 999049 in repeated cycles of controlled ovarian stimulation in women undergoing an assisted reproductive technology programme

A controlled, assessor-blind, parallel groups, multicentre, multinational trial evaluating the immunogenicity of FE 999049 in repeated cycles of controlled ovarian stimulation in women undergoing an assisted reproductive technology programme - ESTHER-2

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-001616-30-BE

Enrollment

400

Registered

2013-08-07

Start date

2013-09-17

Completion date

Unknown

Last updated

2017-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility MedDRA version: 16.0 Level: PT Classification code 10021926 Term: Infertility System Organ Class: 10038604 - Reproductive system and breast disorders

Interventions

Product Name: FE 999049 Product Code: FE 999049 Pharmaceutical Form: Solution for injection INN or Proposed INN: FE 999049 Current Sponsor code: FE 999049 Other descriptive name: human recombinant fol

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Subjects who participated in ESTHER-1 - trial 000004 (COS cycle 1) and failed to achieve an ongoing pregnancy may be included in this trial. Subjects failing to achieve an ongoing pregnancy in COS cycle 2 may be offered to start COS cycle 3 after ensuring that they are still compliant with the eligibility criteria. Continuation to COS cycle 3 is only an option until the required number of subjects have been included (approximately 200). [COS controlled ovarian stimulation] Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 400 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Any clinically relevant changes to any of the eligibility criteria in the previous cycle(s)

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the immunogenicity of FE 999049 and GONAL-F based on the presence of anti-FSH antibodies and their neutralising capacity in women undergoing repeated controlled ovarian stimulation cycles;Secondary Objective: To evaluate the effect of FE 999049 and GONAL-F in repeated controlled ovarian stimulation cycles on ovarian response, including follicular development and endocrine profile, as well as on embryo development, treatment efficiency and pregnancy rates in the fresh cycles To evaluate the safety profile of FE 999049 and GONAL-F, including adverse events, routine safety laboratory parameters and local tolerability, in repeated controlled ovarian stimulation cycles To evaluate FE 999049 with GONAL-F with respect to cost-effectiveness To evaluate FE 999049 in an expanded dose range ;Primary end point(s): Proportion of subjects with treatment-induced anti-FSH antibodies after up to two repeated controlled ovarian stimulation cycles;Timepoint(s) of evaluation of this end point: Stimulation day 1, 7-10 days after last FE 999049 or GONAL-F dose and 21-28 days after last FE 999049 or GONAL-F dose	—

Measure

Time frame

Main Objective: To evaluate the immunogenicity of FE 999049 and GONAL-F based on the presence of anti-FSH antibodies and their neutralising capacity in women undergoing repeated controlled ovarian stimulation cycles;Secondary Objective: To evaluate the effect of FE 999049 and GONAL-F in repeated controlled ovarian stimulation cycles on ovarian response, including follicular development and endocrine profile, as well as on embryo development, treatment efficiency and pregnancy rates in the fresh cycles To evaluate the safety profile of FE 999049 and GONAL-F, including adverse events, routine safety laboratory parameters and local tolerability, in repeated controlled ovarian stimulation cycles To evaluate FE 999049 with GONAL-F with respect to cost-effectiveness To evaluate FE 999049 in an expanded dose range ;Primary end point(s): Proportion of subjects with treatment-induced anti-FSH antibodies after up to two repeated controlled ovarian stimulation cycles;Timepoint(s) of evaluation of this end point: Stimulation day 1, 7-10 days after last FE 999049 or GONAL-F dose and 21-28 days after last FE 999049 or GONAL-F dose

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Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: 1. As in Primary End Point 2. As in Primary End Point 3. Stimulation day 6, end-of-stimulation 4. Oocyte retrieval 5. 9 days after triggering 6. End-of-stimulation 7. Prior to insemination, and on culture day 1,3 and 5 8. Stimulation day 6, end-of-stimulation 9. End-of-stimulation 10. 13-15 days after transfer 11. 5-6 weeks after transfer 12. 5-6 weeks after transfer 13. 5-6 weeks after transfer 14. 10-11 weeks after transfer 15. 10-11 weeks after transfer 16. From signing Informed consent until end-of-trial 17. Stimulation day 1, end-of-stimulation, end-of-trial 18. End-of-stimulation;Secondary end point(s): 1. Proportion of subjects with treatment-induced anti-FSH antibodies with neutralising capacity after up to two repeated controlled ovarian stimulation cycles 2. Proportion of subjects with treatment-induced anti-FSH antibodies, overall as well as with neutralising capacity, after one and after two repeated controlled ovarian stimulation cycles 3. Number and size of follicles on stimulation day 6 and end-of stimulation for each controlled ovarian stimulation cycle 4. Proportion of subjects with extreme ovarian responses, defined as <4, =15 or =20 oocytes retrieved, for each controlled ovarian stimulation cycle 5. Proportion of subjects with early OHSS (including OHSS of moderate/severe grade) and/or preventive interventions for early OHSS for each controlled ovarian stimulation cycle 6. Proportion of subjects with cycle cancellation due to poor ovarian response or excessive ovarian response for each controlled ovarian stimulation cycle 7. Percentage of metaphase II oocytes (only applicable for those inseminated using ICSI), fertilisation rate as well as number and quality of embryos on day 3 and blastocysts on day 5 after oocyte retrieval for each controlled ovarian stimulation cycle 8. Circulating concentrations of FSH, LH, estradiol, progesterone, inhibin A and inhibin B on stimulation d	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: 1. As in Primary End Point 2. As in Primary End Point 3. Stimulation day 6, end-of-stimulation 4. Oocyte retrieval 5. 9 days after triggering 6. End-of-stimulation 7. Prior to insemination, and on culture day 1,3 and 5 8. Stimulation day 6, end-of-stimulation 9. End-of-stimulation 10. 13-15 days after transfer 11. 5-6 weeks after transfer 12. 5-6 weeks after transfer 13. 5-6 weeks after transfer 14. 10-11 weeks after transfer 15. 10-11 weeks after transfer 16. From signing Informed consent until end-of-trial 17. Stimulation day 1, end-of-stimulation, end-of-trial 18. End-of-stimulation;Secondary end point(s): 1. Proportion of subjects with treatment-induced anti-FSH antibodies with neutralising capacity after up to two repeated controlled ovarian stimulation cycles 2. Proportion of subjects with treatment-induced anti-FSH antibodies, overall as well as with neutralising capacity, after one and after two repeated controlled ovarian stimulation cycles 3. Number and size of follicles on stimulation day 6 and end-of stimulation for each controlled ovarian stimulation cycle 4. Proportion of subjects with extreme ovarian responses, defined as <4, =15 or =20 oocytes retrieved, for each controlled ovarian stimulation cycle 5. Proportion of subjects with early OHSS (including OHSS of moderate/severe grade) and/or preventive interventions for early OHSS for each controlled ovarian stimulation cycle 6. Proportion of subjects with cycle cancellation due to poor ovarian response or excessive ovarian response for each controlled ovarian stimulation cycle 7. Percentage of metaphase II oocytes (only applicable for those inseminated using ICSI), fertilisation rate as well as number and quality of embryos on day 3 and blastocysts on day 5 after oocyte retrieval for each controlled ovarian stimulation cycle 8. Circulating concentrations of FSH, LH, estradiol, progesterone, inhibin A and inhibin B on stimulation d

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Countries

Belgium, Brazil, Canada, Czech Republic, Denmark, European Union, Italy, Mexico, Poland, Russian Federation, Spain, United Kingdom

Contacts

Public ContactClinical Development Support

Ferring Pharmaceuticals A/S

DK0-Disclosure@ferring.com+452878 76 25

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026