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Completed

NCT Number: NCT01956123

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

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

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

UZ Brussel (there may be other sites in this country), Brussels, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Follitropin Delta (FE 999049)

Drug

Follitropin Alfa (GONAL-F)

Drug

Primary outcomes

  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 participants 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 participants in COS cycle 2 are presented. Participants with observations in both cycles are only counted once.

Secondary outcomes

  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 participants 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 participants in COS cycle 2 are presented. Participants 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 participants 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 participants 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 participants 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)

    Participants 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.

Sponsors and collaborators

Lead sponsor

Ferring Pharmaceuticals

Industry

Registry information

Official study 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

Acronym: ESTHER-2

Important dates

Study start
2014
Primary completion
2015
Study completion
2017
First posted
Oct 8, 2013
Registry last updated
Sep 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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