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

February 1, 2022 updated by: Organon and Co

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.

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

99

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 39 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Corifollitropin alpha
Drug: Puregon®
Subcutaneous Puregon® 150 IU
Other Names:
  • recFSH
Drug: Orgalutran®
Subcutaneous Orgalutran® 0.25 mg
Other Names:
  • 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 Names:
  • Corifollitropin alpha
Drug: Puregon®
Subcutaneous Puregon® 150 IU
Other Names:
  • recFSH
Drug: Orgalutran®
Subcutaneous Orgalutran® 0.25 mg
Other Names:
  • 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 Names:
  • Corifollitropin alpha
Drug: Puregon®
Subcutaneous Puregon® 150 IU
Other Names:
  • recFSH
Drug: Orgalutran®
Subcutaneous Orgalutran® 0.25 mg
Other Names:
  • 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 Names:
  • recFSH
Drug: Orgalutran®
Subcutaneous Orgalutran® 0.25 mg
Other Names:
  • ganirelix (Ganirelix Acetate Injection)
Drug: Pregnyl®
Subcutaneous Pregnyl® 10,000 IU
Other Names:
  • human chorionic gonadatropin
  • hCG

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Day 8 Up to End of Menstrual Cycle

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of Participants Experiencing Cancellation of Menstrual Cycle
Time Frame: Up to End of Menstrual Cycle
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
Up to End of Menstrual Cycle
Number of Good Quality Embryos Obtained
Time Frame: Up to One Menstrual Cycle
Up to One Menstrual Cycle
Number of Participants With Ongoing Pregnancies
Time Frame: Up to 10 Weeks Following hCG Administration
Up to 10 Weeks Following hCG Administration
Number of Participants With Anti-Org 36286 Antibodies
Time Frame: Up to 2 Weeks Following Embryo Transfer
Up to 2 Weeks Following Embryo Transfer
Number of Participants With Abnormal Laboratory Findings
Time Frame: Up to 2 Weeks Following Embryo Transfer
Up to 2 Weeks Following Embryo Transfer
Number of Participants With Abnormal Vital Signs
Time Frame: Up to 2 Weeks Following Embryo Transfer
Up to 2 Weeks Following Embryo Transfer
Number of Participants With Serious Adverse Events (SAEs)
Time Frame: Up to 2 Weeks Following Embryo Transfer
Up to 2 Weeks Following Embryo Transfer

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Organon and Co

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2001

Primary Completion (Actual)

October 15, 2002

Study Completion (Actual)

October 15, 2002

Study Registration Dates

First Submitted

June 18, 2008

First Submitted That Met QC Criteria

June 19, 2008

First Posted (Estimate)

June 20, 2008

Study Record Updates

Last Update Posted (Actual)

February 3, 2022

Last Update Submitted That Met QC Criteria

February 1, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P07015
  • 38807

Plan for Individual participant data (IPD)

Study Data/Documents

  1. CSR Synopsis

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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