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Evidence-based Stimulation Trial With Human rFSH in Europe and Rest of World 2 (ESTHER-2)

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ClinicalTrials.gov Identifier: NCT01956123
Recruitment Status : Completed
First Posted : October 8, 2013
Last Update Posted : February 7, 2017
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals

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

Condition or disease Intervention/treatment Phase
Infertility Drug: FE 999049 Drug: Follitropin alfa (Gonal-F) Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 513 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : October 2013
Actual Primary Completion Date : May 2015
Actual Study Completion Date : January 3, 2017

Arm Intervention/treatment
Experimental: A
FE 999049
Drug: FE 999049
Active Comparator: B
Follitropin alfa (Gonal-F)
Drug: Follitropin alfa (Gonal-F)



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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 ]
  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 [ Time Frame: Up to 28 days after end of the last stimulation period ]
  3. 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 ]
  4. Vital pregnancy rate for each controlled ovarian stimulation cycle [ Time Frame: 5-6 weeks after blastocyst transfer ]
  5. Implantation rate for each controlled ovarian stimulation cycle [ Time Frame: 5-6 weeks after blastocyst transfer ]
  6. Ongoing pregnancy rate for each controlled ovarian stimulation cycle [ Time Frame: 10-11 weeks after blastocyst transfer ]
  7. Ongoing implantation rate for each controlled ovarian stimulation cycle [ Time Frame: 10-11 weeks after blastocyst transfer ]
  8. 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 ]
  9. 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 ]
  10. Technical malfunctions of the administration pen for each controlled ovarian stimulation cycle [ Time Frame: Up to 20 stimulation days ]


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01956123


Locations
Belgium
UZ Brussel (there may be other sites in this country)
Brussels, Belgium
Brazil
Fertilitat and PUC-RS (there may be other sites in this country)
Porto Alegro, Rio Grande Do Sul, Brazil
Canada, British Columbia
Pacific Centre for Reproductive Medicine
Burnaby, British Columbia, Canada
Olive Fertility Centre
Vancouver, British Columbia, Canada
Canada, Ontario
Ottawa Fertility Centre
Ottawa, Ontario, Canada
Czech Republic
IVF CUBE SE (there may be other sites in this country)
Prague, Czech Republic
Denmark
Rigshospitalet Fertilitetsklinikken (there may be other sites in this country)
Copenhagen, Denmark
France
Department of Endocrine Gynaecology and Reproductive Medicine, Hôpital Jeanne de Flandre (there may be other sites in this country)
Lille, France
Italy
Centro Natalità San Raffaele (there may be other sites in this country)
Milano, Italy
Poland
The nOvum Clinic (there may be other sites in this country)
Warszawa, Poland
Russian Federation
IVF & Reproductive Genetics Center (there may be other sites in this country)
Moscow, Russian Federation
Spain
IVI Sevilla (there may be other sites in this country)
Sevilla, Spain
United Kingdom
Glasgow Centre for Reproductive Medicine Ltd. (there may be other sites in this country)
Glasgow, United Kingdom
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals

Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01956123     History of Changes
Other Study ID Numbers: 000071
2013-001616-30 ( EudraCT Number )
U1111-1147-6922 ( Other Identifier: WHO )
First Posted: October 8, 2013    Key Record Dates
Last Update Posted: February 7, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Follicle Stimulating Hormone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs