FertilizationPhase 2NCT00598208
A Phase 2, Trial to Investigate the Dose-Response Relationship of a Single Injection of Org 36286 (Corifollitropin Alfa) to Initiate Multiple Follicular Growth in a Controlled Ovarian (Study 38826)(P06055)(COMPLETED)
A Phase 2 study testing corifollitropin alfa and Follitropin beta injection in people with Fertilization, run by Organon and Co.
Trial summary
The primary objective of this trial is to investigate the dose -response relationship of a single injection of Org 38286 to initiate multifollicular growth for the first seven days in a controlled ovarian hyperstimulation (COH) protocol for IVF or ICSI. Read more about this study
- Who is it for?
- Ages 18 to 39 years, women only
- Conditions the study is for
- Fertilization
- What is being tested?
- corifollitropin alfa and Follitropin beta injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 325 participants
- Where
- No sites listed yet
- Study dates
- 19 May 2003to 15 Mar 2004
- 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 ICSI;
- >=18 and <=39 years of age at the time of signing informed consent;
- BMI >=18 and <=29 kg/m^2;
- Normal menstrual cycle length: 24-35 days;
- Ejaculatory sperm (use of donated and/or frozen sperm is allowed);
- Willing and able to sign informed consent.
Who cannot join
- History of/or any current (treated) endocrine abnormality;
- History of ovarian hyperstimulation syndrome (OHSS);
- History of/or current polycystic ovary syndrome (PCOS) or current polycystic ovaries according to USS (at least 10 follicles of 2-8 mm in each ovary);
- More than three unsuccessful COH cycles since the last established ongoing pregnancy (if applicable);
- History of non- or low ovarian response to FSH/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, LH, E2, P, total T, TSH and prolactin):
Show all 16Show fewer
- Any clinically relevant abnormal laboratory value;
- Less than 2 ovaries;
- 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 of presence of alcohol or drug abuse within 12 months prior to signing informed consent;
- Previous use of Org 36286;
- Use of hormonal preparations within 1 month prior to randomization;
- Hypersensitivity to Org 32489 (Puregon®) and/or Org 37462 (Orgalutran®) and/or Pregnyl® or any of their components;
- Administration of investigational drugs within three months prior to signing informed consent.
About this study
Official title: A Phase 2, Open Label, Randomized Trial to Investigate the Dose-Response Relationship of a Single Injection of Org 36286 (Corifollitropin Alfa) to Initiate Multiple Follicular Growth in a Controlled Ovarian Hyperstimulation Protocol for IVF or ICSI.
The primary objective of this trial is to investigate the dose -response relationship of a single injection of Org 38286 to initiate multifollicular growth for the first seven days in a controlled ovarian hyperstimulation (COH) protocol for IVF or ICSI.
- Conditions
- Fertilization
- Being tested
- corifollitropin alfa, Follitropin beta injection
- Keywords
- In-vitro fertilization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
corifollitropin alfaDrug
Also called Org 36286
On Cycle Day 2, a single injection of 60 μg, 120 μg, or 180 μg Org 36286 was administered. One week later (Treatment Day 8), treatment was continued with a fixed daily subcutaneous (SC) dose of 150 IU Puregon® up to and including the Day of hCG. Orgalutran® (0.25 mg) was administered once daily SC starting on Treatment Day 5 and up to and including the Day of hCG. The maximum total treatment duration was 19 days.
Follitropin beta injectionDrug
Also called Follistim®, Puregon®
Starting on Cycle Day 2, a fixed daily dose of 150 IU Puregon® SC was administered for the entire stimulation period up to and including the Day of hCG. Orgalutran® (0.25 mg) was administered once daily SC starting on Treatment Day 5 and given up to and including the day of hCG. The maximum total treatment duration was 19 days.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 60 µg Org 36286 (corifollitropin alfa) Receives: Drug: corifollitropin alfa |
| 2 | Experimental | 120 µg Org 36286 (corifollitropin alfa) Receives: Drug: corifollitropin alfa |
| 3 | Experimental | 180 µg Org 36286 (corifollitropin alfa) Receives: Drug: corifollitropin alfa |
| 4 | Active comparator | Follitropin beta injection Receives: Drug: Follitropin beta injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of cumulus-oocyte-complexes retrieved
Measured: 1 cycle
Secondary outcomes (1)
Treatment failure rate
Measured: 1 cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2008 (estimated)
- Study start19 May 2003
- Primary completion15 Mar 2004
- Study completion15 Mar 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for FertilizationStudies 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
- 325 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
- NCT00598208
- Sponsor's protocol ID
- P06055
- Other IDs
- 38826
- Status last verified
- Feb 2022
- First submitted
- 10 Jan 2008
- Last updated
- 15 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Zandvliet AS, Prohn M, de Greef R, van Aarle F, McCrary Sisk C, Stegmann BJ. Impact of patient characteristics on the pharmacokinetics of corifollitropin alfa during controlled ovarian stimulation. Br J Clin Pharmacol. 2016 Jul;82(1):74-82. doi: 10.1111/bcp.12939. Epub 2016 May 31.
PubMed 26991902Corifollitropin Alfa Dose-finding Study Group. A randomized dose-response trial of a single injection of corifollitropin alfa to sustain multifollicular growth during controlled ovarian stimulation. Hum Reprod. 2008 Nov;23(11):2484-92. doi: 10.1093/humrep/den288. Epub 2008 Aug 6.
PubMed 18684735
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 2, Open Label, Randomized Trial to Investigate the Dose-Response Relationship of a Single Injection of Org 36286 (Corifollitropin Alfa) to Initiate Multiple Follicular Growth in a Controlled Ovarian Hyperstimulation Protocol for IVF or ICSI.
- ClinicalTrials.gov ID
- NCT00598208
- Acronym / sponsor ID
- P06055
- Conditions
- Fertilization
- Keywords
- In-vitro fertilization
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 325 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- 19 May 2003 (actual)
- Primary completion
- 15 Mar 2004 (actual)
- Study completion
- 15 Mar 2004 (actual)
- First posted
- 21 Jan 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 is to investigate the dose -response relationship of a single injection of Org 38286 to initiate multifollicular growth for the first seven days in a controlled ovarian hyperstimulation (COH) protocol for IVF or ICSI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: corifollitropin alfa60 µg Org 36286 (corifollitropin alfa) |
| 2 | Experimental | Drug: corifollitropin alfa120 µg Org 36286 (corifollitropin alfa) |
| 3 | Experimental | Drug: corifollitropin alfa180 µg Org 36286 (corifollitropin alfa) |
| 4 | Active comparator | Drug: Follitropin beta injectionFollitropin beta injection |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Females of couples with an indication for COH and IVF or ICSI;
- >=18 and <=39 years of age at the time of signing informed consent;
- BMI >=18 and <=29 kg/m^2;
- Normal menstrual cycle length: 24-35 days;
- Ejaculatory sperm (use of donated and/or frozen sperm is allowed);
Key exclusion criteria (16 listed)
- History of/or any current (treated) endocrine abnormality;
- History of ovarian hyperstimulation syndrome (OHSS);
- History of/or current polycystic ovary syndrome (PCOS) or current polycystic ovaries according to USS (at least 10 follicles of 2-8 mm in each ovary);
- More than three unsuccessful COH cycles since the last established ongoing pregnancy (if applicable);
- History of non- or low ovarian response to FSH/hMG treatment;
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 |
|---|---|---|
| corifollitropin alfaAlso: Org 36286On Cycle Day 2, a single injection of 60 μg, 120 μg, or 180 μg Org 36286 was administered. One week later (Treatment Day 8), treatment was continued with a fixed daily subcutaneous (SC) dose of 150 IU Puregon® up to and including the Day of hCG. Orgalutran® (0.25 mg) was administered once daily SC starting on Treatment Day 5 and up to and including the Day of hCG. The maximum total treatment duration was 19 days. | Drug | 1, 2, 3 |
| Follitropin beta injectionAlso: Follistim®, Puregon®Starting on Cycle Day 2, a fixed daily dose of 150 IU Puregon® SC was administered for the entire stimulation period up to and including the Day of hCG. Orgalutran® (0.25 mg) was administered once daily SC starting on Treatment Day 5 and given up to and including the day of hCG. The maximum total treatment duration was 19 days. | Drug | 4 |
Primary outcome
Number of cumulus-oocyte-complexes retrieved
Time frame: 1 cycle
1 secondary outcome
Treatment failure rate
Time frame: 1 cycle
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.
- Derived from this study: PubMed 26991902Zandvliet AS, Prohn M, de Greef R, van Aarle F, McCrary Sisk C, Stegmann BJ. Impact of patient characteristics on the pharmacokinetics of corifollitropin alfa during controlled ovarian stimulation. Br J Clin Pharmacol. 2016 Jul;82(1):74-82. doi: 10.1111/bcp.12939. Epub 2016 May 31.
- Derived from this study: PubMed 18684735Corifollitropin Alfa Dose-finding Study Group. A randomized dose-response trial of a single injection of corifollitropin alfa to sustain multifollicular growth during controlled ovarian stimulation. Hum Reprod. 2008 Nov;23(11):2484-92. doi: 10.1093/humrep/den288. Epub 2008 Aug 6.
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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 corifollitropin alfa and Follitropin beta injection in people with 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 6 inclusion and 16 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?
Number of cumulus-oocyte-complexes retrieved (time frame: 1 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 NCT00598208, which also lists 2 linked publications.
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.