Overview

This trial is active, not recruiting.

Condition infertility
Treatments fe 999049, follitropin alfa (gonal-f)
Phase phase 3
Sponsor Ferring Pharmaceuticals
Start date October 2013
End date May 2015
Trial size 513 participants
Trial identifier NCT01956123, 000071, 2013-001616-30, U1111-1147-6922

Summary

This trial investigates the immunogenicity of FE 999049 in repeated cycles.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
FE 999049
fe 999049
(Active Comparator)
Follitropin alfa (Gonal-F)
follitropin alfa (gonal-f)

Primary Outcomes

Measure
Proportion of subjects with treatment-induced anti-FSH antibodies after up to two repeated controlled ovarian stimulation cycles
time frame: Up to 28 days after end of the last stimulation period

Secondary Outcomes

Measure
Proportion of subjects with treatment-induced anti-FSH antibodies with neutralising capacity after up to two repeated controlled ovarian stimulation cycles
time frame: Up to 28 days after end of the last stimulation period
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
time frame: Up to 28 days after end of the last stimulation period
Proportion of subject with cycle cancellation due to poor ovarian response or excessive ovarian response for each controlled ovarian stimulation cycle
time frame: Up to 20 stimulation days
Vital pregnancy rate for each controlled ovarian stimulation cycle
time frame: 5-6 weeks after blastocyst transfer
Implantation rate for each controlled ovarian stimulation cycle
time frame: 5-6 weeks after blastocyst transfer
Ongoing pregnancy rate for each controlled ovarian stimulation cycle
time frame: 10-11 weeks after blastocyst transfer
Ongoing implantation rate for each controlled ovarian stimulation cycle
time frame: 10-11 weeks after blastocyst transfer
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
time frame: Up to 20 stimulation days
Proportion of subjects with late OHSS (including OHSS of moderate/severe grade) for each controlled ovarian stimulation cycle
time frame: >9 days after triggering of final follicular maturation
Technical malfunctions of the administration pen for each controlled ovarian stimulation cycle
time frame: Up to 20 stimulation days

Eligibility Criteria

Female participants from 18 years up to 40 years old.

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.

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Ferring Pharmaceuticals.