Evidence-based Stimulation Trial With Human rFSH in Europe and Rest of World 2 (ESTHER-2)
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| ClinicalTrials.gov Identifier: NCT01956123 |
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Recruitment Status :
Completed
First Posted : October 8, 2013
Results First Posted : September 21, 2018
Last Update Posted : September 21, 2018
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Sponsor:
Ferring Pharmaceuticals
Information provided by (Responsible Party):
Ferring Pharmaceuticals
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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 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 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: A
Follitropin Delta (FE 999049) (COS cycle 2)
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Drug: Follitropin Delta (FE 999049) |
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Active Comparator: B
Follitropin Alfa (GONAL-F) (COS cycle 2)
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Drug: Follitropin Alfa (GONAL-F) |
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Experimental: C
Follitropin Delta (FE 999049) (COS cycle 3)
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Drug: Follitropin Delta (FE 999049) |
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Active Comparator: D
Follitropin Alfa (GONAL-F) (COS cycle 3)
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Drug: Follitropin Alfa (GONAL-F) |
Primary Outcome Measures :
- 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 :
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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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 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
| 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 |
| Results First Posted: | September 21, 2018 |
| Last Update Posted: | September 21, 2018 |
| Last Verified: | August 2018 |
Additional relevant MeSH terms:
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Infertility Genital Diseases, Male Genital Diseases, Female Follicle Stimulating Hormone |
Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |