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

NCT00702806 | Completed Phase 2 DMC

• 2 other identifiers: P0701538807
• Study Type: interventional
• Target: 99
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Infertility; In Vitro Fertilization

Keywords

Pharmacological effects of drugs; Hormones; Hormone substitutes and Hormone Antagonists; Pharmacological Actions; Randomized; Multi-center; Multi-national

Outcome Measures

Primary Outcomes (1)

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

  Day 8 Up to End of Menstrual Cycle

Secondary Outcomes (8)

• Number of Participants Experiencing Cancellation of Menstrual Cycle

  Up to End of Menstrual Cycle

• Number of Cumulus-Oocyte-Complexes Experienced By Participants During One Menstrual Cycle

  Up to End of Menstrual Cycle

• Number of Good Quality Embryos Obtained

  Up to One Menstrual Cycle

• Number of Participants With Ongoing Pregnancies

  Up to 10 Weeks Following hCG Administration

• Number of Participants With Anti-Org 36286 Antibodies

  Up to 2 Weeks Following Embryo Transfer

Study Arms (4)

Org 36286 120 μg + Puregon® 150 IU

EXPERIMENTAL

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.

Drug: Org 36286; Drug: Puregon®; Drug: Orgalutran®; Drug: Pregnyl®

Org 36286 180 μg + Puregon® 150 IU

EXPERIMENTAL

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.

Drug: Org 36286; Drug: Puregon®; Drug: Orgalutran®; Drug: Pregnyl®

Org 36286 240 μg + Puregon® 150 IU

EXPERIMENTAL

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.

Drug: Org 36286; Drug: Puregon®; Drug: Orgalutran®; Drug: Pregnyl®

Puregon® 150 IU

ACTIVE COMPARATOR

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.

Drug: Puregon®; Drug: Orgalutran®; Drug: Pregnyl®

Interventions

Org 36286 DRUG

Intra-abdominal injection of Org 36286

Also known as: Corifollitropin alpha

Org 36286 120 μg + Puregon® 150 IU; Org 36286 180 μg + Puregon® 150 IU; Org 36286 240 μg + Puregon® 150 IU

Puregon® DRUG

Subcutaneous Puregon® 150 IU

Also known as: recFSH

Org 36286 120 μg + Puregon® 150 IU; Org 36286 180 μg + Puregon® 150 IU; Org 36286 240 μg + Puregon® 150 IU; Puregon® 150 IU

Orgalutran® DRUG

Subcutaneous Orgalutran® 0.25 mg

Also known as: ganirelix (Ganirelix Acetate Injection)

Org 36286 120 μg + Puregon® 150 IU; Org 36286 180 μg + Puregon® 150 IU; Org 36286 240 μg + Puregon® 150 IU; Puregon® 150 IU

Pregnyl® DRUG

Subcutaneous Pregnyl® 10,000 IU

Also known as: human chorionic gonadatropin, hCG

Org 36286 120 μg + Puregon® 150 IU; Org 36286 180 μg + Puregon® 150 IU; Org 36286 240 μg + Puregon® 150 IU; Puregon® 150 IU

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Organon and Co: lead

Related Publications (1)

• 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.

  PMID: 15126522 RESULT

MeSH Terms

Conditions

Infertility

Interventions

follicle stimulating hormone, human, with HCG C-terminal peptide; follitropin beta; ganirelix; Chorionic Gonadotropin

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropins; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Placental Hormones; Peptides; Amino Acids, Peptides, and Proteins; Pregnancy Proteins; Proteins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2008
• First Posted: June 20, 2008
• Study Start: July 1, 2001
• Primary Completion: October 15, 2002
• Study Completion: October 15, 2002
• Last Updated: August 15, 2024

Record last verified: 2022-02