Phase 3
Completed N=513
Evidence-based Stimulation Trial With Human rFSH in Europe and Rest of World 2
Source: ClinicalTrials.gov NCT01956123 ↗Enrolled (actual)
513
Serious AEs
1.3%
Results posted
Sep 2018
Primary outcomePrimary: Proportion (Percentage) of Subjects With Treatment-induced Anti-Follicle-Stimulating Hormone (FSH) Antibodies After up to Two Repeated Controlled Ovarian Stimulation Cycles — 0.79; 0.38 Percentage of participants
◆ Published Evidence
Established
20citations · ~7 / year
Incidence and severity of ovarian hyperstimulation syndrome (OHSS) in high responders after gonadotropin-releasing hormone (GnRH) agonist trigger in "freeze-all" approach.
Summary
This trial investigates the immunogenicity of FE 999049 in repeated cycles.
Linked Publications (3)
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Incidence and severity of ovarian hyperstimulation syndrome (OHSS) in high responders after gonadotropin-releasing hormone (GnRH) agonist trigger in "freeze-all" approach.
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Pregnancy and neonatal outcomes in fresh and frozen cycles using blastocysts derived from ovarian stimulation with follitropin delta.
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Anti-Müllerian hormone variability and its implications for the number of oocytes retrieved following individualized dosing with follitropin delta.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion (Percentage) of Subjects With Treatment-induced Anti-Follicle-Stimulating Hormone (FSH) Antibodies After up to Two Repeated Controlled Ovarian Stimulation Cycles |
0.79; 0.38 | — |
| SECONDARY Proportion (Percentage) of Subjects With Treatment-induced Anti-FSH Antibodies With Neutralising Capacity After up to Two Repeated Controlled Ovarian Stimulation Cycles |
0.00; 0.00 | — |
| SECONDARY Proportion (Percentage) 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 |
0.79; 0.38; 1.05; 1.08; 0.00; 0.00 | — |
| SECONDARY Proportion (Percentage) of Subjects With Early Ovarian Hyperstimulation Syndrome (OHSS) (Including OHSS of Moderate/Severe Grade) and/or Preventive Interventions for Early OHSS for Each Controlled Ovarian Stimulation Cycle |
0.8; 2.3; 1.1; 0.0; 0.0; 1.9 | — |
| SECONDARY Proportion (Percentage) of Subject With Cycle Cancellation Due to Poor Ovarian Response or Excessive Ovarian Response for Each Controlled Ovarian Stimulation Cycle |
2.0; 3.8; 2.1; 2.2; 0.4; 0.0 | — |
| SECONDARY Vital Pregnancy Rate for Each Controlled Ovarian Stimulation Cycle |
29.4; 27.2; 27.4; 29.0 | — |
| SECONDARY Implantation Rate for Each Controlled Ovarian Stimulation Cycle |
34.6; 30.6; 28.8; 32.2 | — |
| SECONDARY Ongoing Pregnancy Rate for Each Controlled Ovarian Stimulation Cycle |
27.8; 25.7; 27.4; 28 | — |
| SECONDARY Ongoing Implantation Rate for Each Controlled Ovarian Stimulation Cycle |
28.7; 25.5; 25.0; 28.9 | — |
| SECONDARY Frequency of Injection Site Reactions (Redness, Pain, Itching, Swelling and Bruising) Assessed by the Subject During the Stimulation Period for Each Controlled Ovarian Stimulation Cycle |
3.0; 2.4; 2.8; 2.3 | — |
| SECONDARY Proportion (Percentage) of Subjects With Late OHSS (Including OHSS of Moderate/Severe Grade) for Each Controlled Ovarian Stimulation Cycle |
0.4; 0.8; 1.1; 1.1; 0.0; 0.8 | — |
| SECONDARY Technical Malfunctions of the Administration Pen for Each Controlled Ovarian Stimulation Cycle |
0.0; 0.0; 0.0; 0.0 | — |
Eligibility Criteria
Inclusion Criteria
- Informed Consent Documents signed prior to screening evaluations related to this protocol
- Participation in the pivotal efficacy trial (trial 000004/ESTHER-1)
- Anti-FSH antibody results from baseline and at least one post-dosing assessment in the previous cycle(s) available.
- Having undergone the oocyte retrieval procedure, or having had cycle cancellation prior to oocyte retrieval due to poor ovarian response or excessive ovarian response, in the previous cycle(s).
- Failure to achieve ongoing pregnancy in the previous cycle(s).
Exclusion Criteria
- Non-compliance to protocol compliance in the previous cycle(s).
- Having undergone any stimulation with gonadotropins since the end-of-trial / end-of-cycle visit in the previous cycle
- One or more follicles ≥10 mm observed on the transvaginal ultrasound prior to start of dosing on stimulation day 1
- Severe OHSS in a previous cycle.
- Any clinically relevant change to any of the eligibility criteria in the previous cycle(s).
- Clinically relevant medical history since the previous cycle which precludes gonadotropin stimulation or is associated with a reduced chance of pregnancy.
Data sourced from ClinicalTrials.gov (NCT01956123) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.