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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
Results First Posted : September 21, 2018
Last Update Posted : July 15, 2021
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals

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

Condition or disease Intervention/treatment Phase
Infertility Drug: Follitropin Delta (FE 999049) Drug: Follitropin Alfa (GONAL-F) Phase 3

Study Design
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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
Actual Study Start Date : March 26, 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : January 3, 2017
Arms and Interventions
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Arm Intervention/treatment
Experimental: A
Follitropin Delta (FE 999049) (COS cycle 2)
 Drug: Follitropin Delta (FE 999049)
Active Comparator: B
Follitropin Alfa (GONAL-F) (COS cycle 2)
 Drug: Follitropin Alfa (GONAL-F)
Experimental: C
Follitropin Delta (FE 999049) (COS cycle 3)
 Drug: Follitropin Delta (FE 999049)
Active Comparator: D
Follitropin Alfa (GONAL-F) (COS cycle 3)
 Drug: Follitropin Alfa (GONAL-F)


Outcome Measures
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Primary Outcome Measures :
  1. Proportion (Percentage) of Subjects With Treatment-induced Anti-Follicle-Stimulating Hormone (FSH) Antibodies After up to Two Repeated Controlled Ovarian Stimulation Cycles [ Time Frame: 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 ]
    The proportion (percentage) of subjects with at least one treatment-induced anti-FSH antibody response at any time point is presented. The cumulative incidences in COS cycle 2 and COS cycle 3 divided by subjects in COS cycle 2 are presented. Subjects with observations in both cycles are only counted once.


Secondary Outcome Measures :
  1. Proportion (Percentage) of Subjects With Treatment-induced Anti-FSH Antibodies With Neutralising Capacity After up to Two Repeated Controlled Ovarian Stimulation Cycles [ Time Frame: 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 ]
    The proportion (percentage) of subjects with treatment-induced anti-FSH antibodies with neutralising capacity at any time point is presented. The cumulative incidences in COS cycle 2 and COS cycle 3 divided by subjects in COS cycle 2 are presented. Subjects with observations in both cycles are only counted once.

  2. 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 [ Time Frame: 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 ]
    The proportion (percentage) of subjects with treatment-induced anti-FSH antibodies, overall as well as with neutralising capacity, after one and after two repeated COS cycles is presented.

  3. 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 [ Time Frame: ≤9 days after triggering of final follicular maturation. ]
    The proportion (percentage) of subjects with early OHSS, early OHSS of moderate or severe grade, preventive interventions for early OHSS, early OHSS and/or preventive interventions for early OHSS, and early OHSS of moderate or severe grade and/or preventive interventions for early OHSS are presented.

  4. Proportion (Percentage) of Subject With Cycle Cancellation Due to Poor Ovarian Response or Excessive Ovarian Response for Each Controlled Ovarian Stimulation Cycle [ Time Frame: End-of-stimulation (up to 20 stimulation days) ]
    Proportion (percentage) of subjects with cycle cancellation due to poor ovarian response, excessive ovarian response, and triggering with gonadotropin-releasing hormone (GnRH) agonist are presented.

  5. Vital Pregnancy Rate for Each Controlled Ovarian Stimulation Cycle [ Time Frame: 5-6 weeks after blastocyst transfer ]
    Vital pregnancy was defined as at least one intrauterine gestational sac with fetal heart beat 5-6 weeks after blastocyst transfer.

  6. Implantation Rate for Each Controlled Ovarian Stimulation Cycle [ Time Frame: 5-6 weeks after blastocyst transfer ]
    Implantation rate was defined as the number of gestational sacs 5-6 weeks after transfer divided by number of blastocysts transferred.

  7. Ongoing Pregnancy Rate for Each Controlled Ovarian Stimulation Cycle [ Time Frame: 10-11 weeks after blastocyst transfer ]
    Ongoing pregnancy rate was defined as at least one intrauterine viable fetus 10-11 weeks after blastocyst transfer.

  8. Ongoing Implantation Rate for Each Controlled Ovarian Stimulation Cycle [ Time Frame: 10-11 weeks after blastocyst transfer ]
    Ongoing implantation rate was defined as the number of intrauterine viable fetuses 10-11 weeks after transfer divided by number of blastocysts transferred.

  9. 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: End-of-stimulation (up to 20 stimulation days) ]
    Subjects self-assessed injection site reactions (redness, itching, pain, swelling and bruising) immediately, 30 minutes and 24 hours after each injection. The injection site reactions were assessed as none, mild, moderate and severe. The frequency of injection site reactions (mild, moderate or severe) based on all assessment performed is presented.

  10. Proportion (Percentage) 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 ]
    Late OHSS was defined as OHSS with onset >9 days after triggering of final follicular maturation.

  11. Technical Malfunctions of the Administration Pen for Each Controlled Ovarian Stimulation Cycle [ Time Frame: End-of-stimulation (up to 20 stimulation days) ]
    Incidences of confirmed technical malfunction of administration pen are presented.


Eligibility Criteria
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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.
Contacts and Locations
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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
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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 Alegre, 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
Czechia
IVF CUBE SE (there may be other sites in this country)
Prague, Czechia
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
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Study Director: Clinical Development Support Ferring Pharmaceuticals
More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01956123    
Other Study ID Numbers: 000071
2013-001616-30 ( EudraCT Number )
U1111-1147-6922 ( Other Identifier: WHO )
First Posted: October 8, 2013    Key Record Dates
Results First Posted: September 21, 2018
Last Update Posted: July 15, 2021
Last Verified: August 2018
Additional relevant MeSH terms:
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Infertility
Follicle Stimulating Hormone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs