InfertilityPhase 2NCT00702806
Investigate Dose of Org 36286 to Initiate Multiple Follicular Growth in a Controlled Ovarian Hyperstimulation Protocol for IVF or IVF/ICSI (P07015)
A Phase 2 study testing Org 36286, Puregon® and Orgalutran® in people with Infertility and In Vitro Fertilization, run by Organon and Co.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 39 years, women only
- Conditions the study is for
- Infertility, In Vitro Fertilization
- What is being tested?
- Org 36286, Puregon® and Orgalutran®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2001to 15 Oct 2002
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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;
Who cannot join
- 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;
Show all 12Show fewer
- 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.
About this study
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.
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).
Read the 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.
- Conditions
- Infertility, In Vitro Fertilization
- Being tested
- Org 36286, Puregon®, Orgalutran®, Pregnyl®
- Keywords
- Pharmacological effects of drugs, Hormones, Hormone substitutes and Hormone Antagonists, Pharmacological Actions, Randomized, Multi-center, Multi-national
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Org 36286Drug
Also called Corifollitropin alpha
Intra-abdominal injection of Org 36286
Puregon®Drug
Also called recFSH
Subcutaneous Puregon® 150 IU
Orgalutran®Drug
Also called ganirelix (Ganirelix Acetate Injection)
Subcutaneous Orgalutran® 0.25 mg
Pregnyl®Drug
Also called human chorionic gonadatropin, hCG
Subcutaneous Pregnyl® 10,000 IU
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Puregon®; Drug: Orgalutran®; Drug: Pregnyl® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median Puregon® Dose (IU) Required To Reach Criteria for Administration of Human Chorionic Gonadotropin (hCG) For Induction of Final Oocyte Maturation
Measured: Day 8 Up to End of Menstrual Cycle
Secondary outcomes (8)
Number of Participants Experiencing Cancellation of Menstrual Cycle
Measured: Up to End of Menstrual Cycle
Number of Cumulus-Oocyte-Complexes Experienced By Participants During One Menstrual Cycle
Measured: Up to End of Menstrual Cycle
Number of Good Quality Embryos Obtained
Measured: Up to One Menstrual Cycle
Number of Participants With Ongoing Pregnancies
Measured: Up to 10 Weeks Following hCG Administration
Number of Participants With Anti-Org 36286 Antibodies
Measured: Up to 2 Weeks Following Embryo Transfer
Number of Participants With Abnormal Laboratory Findings
Measured: Up to 2 Weeks Following Embryo Transfer
Number of Participants With Abnormal Vital Signs
Measured: Up to 2 Weeks Following Embryo Transfer
Number of Participants With Serious Adverse Events (SAEs)
Measured: Up to 2 Weeks Following Embryo Transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2008 (estimated)
- Study start1 Jul 2001
- Primary completion15 Oct 2002
- Study completion15 Oct 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00702806
- Sponsor's protocol ID
- P07015
- Other IDs
- 38807
- Status last verified
- Feb 2022
- First submitted
- 18 Jun 2008
- Last updated
- 15 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 15126522
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00702806
- Acronym / sponsor ID
- P07015
- Conditions
- Infertility, In Vitro Fertilization
- Keywords
- Pharmacological effects of drugs, Hormones, Hormone substitutes and Hormone Antagonists, Pharmacological Actions, Randomized, Multi-center, Multi-national
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2001 (actual)
- Primary completion
- 15 Oct 2002 (actual)
- Study completion
- 15 Oct 2002 (actual)
- First posted
- 20 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Org 36286 120 μg + Puregon® 150 IU | Experimental | Drug: Org 36286, Drug: Puregon®, Drug: Orgalutran®, Drug: Pregnyl®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. |
| Org 36286 180 μg + Puregon® 150 IU | Experimental | Drug: Org 36286, Drug: Puregon®, Drug: Orgalutran®, Drug: Pregnyl®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. |
| Org 36286 240 μg + Puregon® 150 IU | Experimental | Drug: Org 36286, Drug: Puregon®, Drug: Orgalutran®, Drug: Pregnyl®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. |
| Puregon® 150 IU | Active comparator | Drug: Puregon®, Drug: Orgalutran®, Drug: Pregnyl®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. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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;
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Org 36286Also: Corifollitropin alphaIntra-abdominal injection of Org 36286 | Drug | Org 36286 120 μg + Puregon® 150 IU, Org 36286 180 μg + Puregon® 150 IU, Org 36286 240 μg + Puregon® 150 IU |
| Puregon®Also: recFSHSubcutaneous Puregon® 150 IU | Drug | 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®Also: ganirelix (Ganirelix Acetate Injection)Subcutaneous Orgalutran® 0.25 mg | Drug | 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®Also: human chorionic gonadatropin, hCGSubcutaneous Pregnyl® 10,000 IU | Drug | Org 36286 120 μg + Puregon® 150 IU, Org 36286 180 μg + Puregon® 150 IU, Org 36286 240 μg + Puregon® 150 IU, Puregon® 150 IU |
Primary outcome
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
8 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2024.
- Results publication: PubMed 15126522Devroey 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Org 36286, Puregon® and Orgalutran® in people with Infertility and In Vitro Fertilization, run by Organon and Co.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00702806, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2024.