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Investigate Dose of Org 36286 to Initiate Multiple Follicular Growth in a Controlled Ovarian Hyperstimulation Protocol for IVF or IVF/ICSI (P07015)

Primary Purpose

Infertility, In Vitro Fertilization

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Org 36286
Puregon®
Orgalutran®
Pregnyl®
Sponsored by
Organon and Co
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring Pharmacological effects of drugs, Hormones, Hormone substitutes and Hormone Antagonists, Pharmacological Actions, Randomized, Multi-center, Multi-national

Eligibility Criteria

18 Years - 39 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Females of couples with an indication for COH and IVF or IVF/ICSI;
  • Body mass index (BMI) >=18 and <=29 kg/m^2;
  • Normal menstrual cycle length: 24-35 days;
  • Ejaculatory sperm;

Exclusion Criteria:

  • History of/or current endocrine abnormality such as polycystic ovary syndrome (PCOS), or polycystic ovaries according to ultrasound scan (USS), (treated) hyperprolactinemia or evidence of ovarian dysfunction;
  • More than three unsuccessful COH cycles for IVF since the last established ongoing pregnancy (if applicable);
  • History of non- or low ovarian response to FSH/human menopausal gonadotropin (hMG) treatment;
  • Any clinically relevant hormone value outside the reference range during the early follicular phase (menstrual Cycle Day 2-7) as measured by the local laboratory (FSH, luteinizing hormone [LH], estradiol [E2], progesterone [P], total testosterone [T], thyroid stimulating hormone [TSH], and prolactin);
  • Any clinically relevant abnormal laboratory value;
  • Any ovarian and/or abdominal abnormality interfering with ultrasound examination;
  • Contraindications for the use of gonadotropins (e.g. tumors, pregnancy/lactation, undiagnosed vaginal bleeding, hypersensitivity, ovarian cysts);
  • Epilepsy, diabetes, cardiovascular, gastro-intestinal, hepatic, renal, pulmonary, or abdominal disease;
  • History or presence of alcohol or drug abuse within 12 months prior to signing informed consent;
  • Hypersensitivity to Orgalutran® or any of its components;
  • Administration of investigational drugs within three months prior to screening.
  • Use of hormonal preparations within one month prior to the start of Org 36286 with the exception of thyroid medication.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Active Comparator

    Arm Label

    Org 36286 120 μg + Puregon® 150 IU

    Org 36286 180 μg + Puregon® 150 IU

    Org 36286 240 μg + Puregon® 150 IU

    Puregon® 150 IU

    Arm Description

    On Cycle Day 2 or Day 3, a single intra-abdominal injection of Org 36286 120 μg was administered to participants. On stimulation Day 8, a daily subcutaneous dose of Puregon® 150 IU was administered up to and including the time of Pregnyl® administration as a single dose of 10,000 IU subcutaneously. The maximum treatment duration of Puregon® 150 IU was 19 days. Orgalutran® 0.25 mg was administered subcutaneously once daily up to and including the day of Pregnyl®, when the leading follicle reached a size of >= 14 mm.

    Cycle Day 2 or Day 3, a single intra-abdominal injection of Org 36286 180 μg was administered to participants. On stimulation Day 8, a daily subcutaneous dose of Puregon® 150 IU was administered up to and including the time of Pregnyl® administration as a single dose of 10,000 IU subcutaneously. The maximum treatment duration of Puregon® 150 IU was 19 days. Orgalutran® 0.25 mg was administered subcutaneously once daily up to and including the day of Pregnyl®, when the leading follicle reached a size of >= 14 mm.

    Cycle Day 2 or Day 3, a single intra-abdominal injection of Org 36286 240 μg was administered to participants. On stimulation Day 8, a daily subcutaneous dose of Puregon® 150 IU was administered up to and including the time of Pregnyl® administration as a single dose of 10,000 IU subcutaneously. The maximum treatment duration of Puregon® 150 IU was 19 days. Orgalutran® 0.25 mg was administered subcutaneously once daily up to and including the day of Pregnyl®, when the leading follicle reached a size of >= 14 mm.

    On stimulation Day 8, a daily subcutaneous dose of Puregon® 150 IU was administered up to and including the time of Pregnyl® administration as a single dose of 10,000 IU subcutaneously. The maximum treatment duration of Puregon® 150 IU was 19 days. Orgalutran® 0.25 mg was administered subcutaneously once daily up to and including the day of Pregnyl®, when the leading follicle reached a size of >= 14 mm.

    Outcomes

    Primary Outcome Measures

    Median Puregon® Dose (IU) Required To Reach Criteria for Administration of Human Chorionic Gonadotropin (hCG) For Induction of Final Oocyte Maturation

    Secondary Outcome Measures

    Number of Participants Experiencing Cancellation of Menstrual Cycle
    Number of Cumulus-Oocyte-Complexes Experienced By Participants During One Menstrual Cycle
    Number of Good Quality Embryos Obtained
    Number of Participants With Ongoing Pregnancies
    Number of Participants With Anti-Org 36286 Antibodies
    Number of Participants With Abnormal Laboratory Findings
    Number of Participants With Abnormal Vital Signs
    Number of Participants With Serious Adverse Events (SAEs)

    Full Information

    First Posted
    June 18, 2008
    Last Updated
    February 1, 2022
    Sponsor
    Organon and Co
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00702806
    Brief Title
    Investigate Dose of Org 36286 to Initiate Multiple Follicular Growth in a Controlled Ovarian Hyperstimulation Protocol for IVF or IVF/ICSI (P07015)
    Official Title
    A Phase II, Open Label, Prospective, Randomized, Comparative Clinical Trial to Investigate the Appropriate Dose of a Single Injection of Org 36286 (Corifollitropin Alfa) to Initiate Multiple Follicular Growth in a Controlled Ovarian Hyperstimulation Protocol for IVF or IVF/ICSI.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    July 1, 2001 (Actual)
    Primary Completion Date
    October 15, 2002 (Actual)
    Study Completion Date
    October 15, 2002 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Organon and Co

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The primary objective of this trial was to investigate the appropriate dose of a single injection of Org 36286 to initiate multifollicular growth for the first seven days in a controlled ovarian hyperstimulation (COH) protocol for IVF and IVF/ICSI. After seven days, participants were converted to treatment with Puregon® 150 IU and administration of the GnRH antagonist Orgalutran® to finalize the stimulation cycle. Secondary objectives were the safety (including the absence of antibody formation) and the direct effects of Org 36286 on reproductive functions (steroidogenesis, oocyte maturation, embryo quality and implantation).
    Detailed Description
    This trial was made up of two stages with different designs and was conducted at two clinical trial sites. Stage I was open-label and uncontrolled in a small cohort of women (n=6) to obtain first experience in employing Org 36286 in women meeting all inclusion and none of the exclusion criteria. Based on the results of a previous study, the most appropriate dose was anticipated to be 120 μg Org 36286, which was administered on Cycle Day 2 or 3. After seven days, treatment was continued with a fixed dose of 150 IU Puregon® SC. If the size of the leading follicle was >=14 mm, 0.25 mg Orgalutran® SC once daily was administered concurrently with 150 IU Puregon® up to and including the day of hCG. The maximum total treatment duration was 19 days. Treatment of the first two participants with Org 36286 120 μg, that was expected to be adequate for COH, was cancelled due to disrupted follicular growth beyond Day 7. Therefore, the dose of Org 36286 was adapted from 120 μg to 180 µg. Treatment of the first participants gave an indication of the validity of the anticipated doses to be used in Stage II, the actual dose-finding trial. Stage II was open-label, prospective and randomized, comparing three experimental regimens differing in dose of Org 36286 (120 μg, 180 μg, or 240 μg) with a reference treatment. Post-treatment assessments were completed at the visit two weeks after embryo transfer.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Infertility, In Vitro Fertilization
    Keywords
    Pharmacological effects of drugs, Hormones, Hormone substitutes and Hormone Antagonists, Pharmacological Actions, Randomized, Multi-center, Multi-national

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    99 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Org 36286 120 μg + Puregon® 150 IU
    Arm Type
    Experimental
    Arm Description
    On Cycle Day 2 or Day 3, a single intra-abdominal injection of Org 36286 120 μg was administered to participants. On stimulation Day 8, a daily subcutaneous dose of Puregon® 150 IU was administered up to and including the time of Pregnyl® administration as a single dose of 10,000 IU subcutaneously. The maximum treatment duration of Puregon® 150 IU was 19 days. Orgalutran® 0.25 mg was administered subcutaneously once daily up to and including the day of Pregnyl®, when the leading follicle reached a size of >= 14 mm.
    Arm Title
    Org 36286 180 μg + Puregon® 150 IU
    Arm Type
    Experimental
    Arm Description
    Cycle Day 2 or Day 3, a single intra-abdominal injection of Org 36286 180 μg was administered to participants. On stimulation Day 8, a daily subcutaneous dose of Puregon® 150 IU was administered up to and including the time of Pregnyl® administration as a single dose of 10,000 IU subcutaneously. The maximum treatment duration of Puregon® 150 IU was 19 days. Orgalutran® 0.25 mg was administered subcutaneously once daily up to and including the day of Pregnyl®, when the leading follicle reached a size of >= 14 mm.
    Arm Title
    Org 36286 240 μg + Puregon® 150 IU
    Arm Type
    Experimental
    Arm Description
    Cycle Day 2 or Day 3, a single intra-abdominal injection of Org 36286 240 μg was administered to participants. On stimulation Day 8, a daily subcutaneous dose of Puregon® 150 IU was administered up to and including the time of Pregnyl® administration as a single dose of 10,000 IU subcutaneously. The maximum treatment duration of Puregon® 150 IU was 19 days. Orgalutran® 0.25 mg was administered subcutaneously once daily up to and including the day of Pregnyl®, when the leading follicle reached a size of >= 14 mm.
    Arm Title
    Puregon® 150 IU
    Arm Type
    Active Comparator
    Arm Description
    On stimulation Day 8, a daily subcutaneous dose of Puregon® 150 IU was administered up to and including the time of Pregnyl® administration as a single dose of 10,000 IU subcutaneously. The maximum treatment duration of Puregon® 150 IU was 19 days. Orgalutran® 0.25 mg was administered subcutaneously once daily up to and including the day of Pregnyl®, when the leading follicle reached a size of >= 14 mm.
    Intervention Type
    Drug
    Intervention Name(s)
    Org 36286
    Other Intervention Name(s)
    Corifollitropin alpha
    Intervention Description
    Intra-abdominal injection of Org 36286
    Intervention Type
    Drug
    Intervention Name(s)
    Puregon®
    Other Intervention Name(s)
    recFSH
    Intervention Description
    Subcutaneous Puregon® 150 IU
    Intervention Type
    Drug
    Intervention Name(s)
    Orgalutran®
    Other Intervention Name(s)
    ganirelix (Ganirelix Acetate Injection)
    Intervention Description
    Subcutaneous Orgalutran® 0.25 mg
    Intervention Type
    Drug
    Intervention Name(s)
    Pregnyl®
    Other Intervention Name(s)
    human chorionic gonadatropin, hCG
    Intervention Description
    Subcutaneous Pregnyl® 10,000 IU
    Primary Outcome Measure Information:
    Title
    Median Puregon® Dose (IU) Required To Reach Criteria for Administration of Human Chorionic Gonadotropin (hCG) For Induction of Final Oocyte Maturation
    Time Frame
    Day 8 Up to End of Menstrual Cycle
    Secondary Outcome Measure Information:
    Title
    Number of Participants Experiencing Cancellation of Menstrual Cycle
    Time Frame
    Up to End of Menstrual Cycle
    Title
    Number of Cumulus-Oocyte-Complexes Experienced By Participants During One Menstrual Cycle
    Time Frame
    Up to End of Menstrual Cycle
    Title
    Number of Good Quality Embryos Obtained
    Time Frame
    Up to One Menstrual Cycle
    Title
    Number of Participants With Ongoing Pregnancies
    Time Frame
    Up to 10 Weeks Following hCG Administration
    Title
    Number of Participants With Anti-Org 36286 Antibodies
    Time Frame
    Up to 2 Weeks Following Embryo Transfer
    Title
    Number of Participants With Abnormal Laboratory Findings
    Time Frame
    Up to 2 Weeks Following Embryo Transfer
    Title
    Number of Participants With Abnormal Vital Signs
    Time Frame
    Up to 2 Weeks Following Embryo Transfer
    Title
    Number of Participants With Serious Adverse Events (SAEs)
    Time Frame
    Up to 2 Weeks Following Embryo Transfer

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    39 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Females of couples with an indication for COH and IVF or IVF/ICSI; Body mass index (BMI) >=18 and <=29 kg/m^2; Normal menstrual cycle length: 24-35 days; Ejaculatory sperm; Exclusion Criteria: History of/or current endocrine abnormality such as polycystic ovary syndrome (PCOS), or polycystic ovaries according to ultrasound scan (USS), (treated) hyperprolactinemia or evidence of ovarian dysfunction; More than three unsuccessful COH cycles for IVF since the last established ongoing pregnancy (if applicable); History of non- or low ovarian response to FSH/human menopausal gonadotropin (hMG) treatment; Any clinically relevant hormone value outside the reference range during the early follicular phase (menstrual Cycle Day 2-7) as measured by the local laboratory (FSH, luteinizing hormone [LH], estradiol [E2], progesterone [P], total testosterone [T], thyroid stimulating hormone [TSH], and prolactin); Any clinically relevant abnormal laboratory value; Any ovarian and/or abdominal abnormality interfering with ultrasound examination; Contraindications for the use of gonadotropins (e.g. tumors, pregnancy/lactation, undiagnosed vaginal bleeding, hypersensitivity, ovarian cysts); Epilepsy, diabetes, cardiovascular, gastro-intestinal, hepatic, renal, pulmonary, or abdominal disease; History or presence of alcohol or drug abuse within 12 months prior to signing informed consent; Hypersensitivity to Orgalutran® or any of its components; Administration of investigational drugs within three months prior to screening. Use of hormonal preparations within one month prior to the start of Org 36286 with the exception of thyroid medication.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    15126522
    Citation
    Devroey P, Fauser BC, Platteau P, Beckers NG, Dhont M, Mannaerts BM. Induction of multiple follicular development by a single dose of long-acting recombinant follicle-Stimulating hormone (FSH-CTP, corifollitropin alfa) for controlled ovarian stimulation before in vitro fertilization. J Clin Endocrinol Metab. 2004 May;89(5):2062-70. doi: 10.1210/jc.2003-031766.
    Results Reference
    result
    Available IPD and Supporting Information:
    Available IPD/Information Type
    CSR Synopsis
    Available IPD/Information URL
    http://www.merck.com/clinical-trials/policies-perspectives.html

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    Investigate Dose of Org 36286 to Initiate Multiple Follicular Growth in a Controlled Ovarian Hyperstimulation Protocol for IVF or IVF/ICSI (P07015)

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