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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)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00702806
First Posted: June 20, 2008
Last Update Posted: May 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  Purpose
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).

Condition Intervention Phase
Infertility In Vitro Fertilization Drug: Org 36286 Drug: Puregon® Drug: Orgalutran® Drug: Pregnyl® Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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 Measures:
  • Number of Participants Experiencing Cancellation of Menstrual Cycle [ Time Frame: Up to End of Menstrual Cycle ]
  • Number of Cumulus-Oocyte-Complexes Experienced By Participants During One Menstrual Cycle [ Time Frame: Up to End of Menstrual Cycle ]
  • Number of Good Quality Embryos Obtained [ Time Frame: Up to One Menstrual Cycle ]
  • Number of Participants With Ongoing Pregnancies [ Time Frame: Up to 10 Weeks Following hCG Administration ]
  • Number of Participants With Anti-Org 36286 Antibodies [ Time Frame: Up to 2 Weeks Following Embryo Transfer ]
  • Number of Participants With Abnormal Laboratory Findings [ Time Frame: Up to 2 Weeks Following Embryo Transfer ]
  • Number of Participants With Abnormal Vital Signs [ Time Frame: Up to 2 Weeks Following Embryo Transfer ]
  • Number of Participants With Serious Adverse Events (SAEs) [ Time Frame: Up to 2 Weeks Following Embryo Transfer ]

Enrollment: 99
Actual Study Start Date: July 1, 2001
Study Completion Date: October 15, 2002
Primary Completion Date: October 15, 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Org 36286 120 μg + Puregon® 150 IU
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
Intra-abdominal injection of Org 36286
Other Name: Corifollitropin alpha
Drug: Puregon®
Subcutaneous Puregon® 150 IU
Other Name: recFSH
Drug: Orgalutran®
Subcutaneous Orgalutran® 0.25 mg
Other Name: ganirelix (Ganirelix Acetate Injection)
Drug: Pregnyl®
Subcutaneous Pregnyl® 10,000 IU
Other Names:
  • human chorionic gonadatropin
  • hCG
Experimental: Org 36286 180 μg + Puregon® 150 IU
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
Intra-abdominal injection of Org 36286
Other Name: Corifollitropin alpha
Drug: Puregon®
Subcutaneous Puregon® 150 IU
Other Name: recFSH
Drug: Orgalutran®
Subcutaneous Orgalutran® 0.25 mg
Other Name: ganirelix (Ganirelix Acetate Injection)
Drug: Pregnyl®
Subcutaneous Pregnyl® 10,000 IU
Other Names:
  • human chorionic gonadatropin
  • hCG
Experimental: Org 36286 240 μg + Puregon® 150 IU
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
Intra-abdominal injection of Org 36286
Other Name: Corifollitropin alpha
Drug: Puregon®
Subcutaneous Puregon® 150 IU
Other Name: recFSH
Drug: Orgalutran®
Subcutaneous Orgalutran® 0.25 mg
Other Name: ganirelix (Ganirelix Acetate Injection)
Drug: Pregnyl®
Subcutaneous Pregnyl® 10,000 IU
Other Names:
  • human chorionic gonadatropin
  • hCG
Active Comparator: Puregon® 150 IU
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®
Subcutaneous Puregon® 150 IU
Other Name: recFSH
Drug: Orgalutran®
Subcutaneous Orgalutran® 0.25 mg
Other Name: ganirelix (Ganirelix Acetate Injection)
Drug: Pregnyl®
Subcutaneous Pregnyl® 10,000 IU
Other Names:
  • human chorionic gonadatropin
  • hCG

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Study Data/Documents: CSR Synopsis  This link exits the ClinicalTrials.gov site

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00702806     History of Changes
Other Study ID Numbers: P07015
38807
First Submitted: June 18, 2008
First Posted: June 20, 2008
Last Update Posted: May 19, 2017
Last Verified: May 2017

Keywords provided by Merck Sharp & Dohme Corp.:
Pharmacological effects of drugs
Hormones
Hormone substitutes and Hormone Antagonists
Pharmacological Actions
Randomized
Multi-center
Multi-national

Additional relevant MeSH terms:
Infertility
Ovarian Hyperstimulation Syndrome
Genital Diseases, Male
Genital Diseases, Female
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases
Ganirelix
Chorionic Gonadotropin
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Reproductive Control Agents