In Vitro FertilizationPhase 2RealizeNCT00702351
A Trial of Single Dose Corifollitropin Alfa's Ability to Induce Multiple Follicular Growth During the First Week of Controlled Ovarian Stimulation for IVF or ICSI (38833)(P05788)
A Phase 2 study testing Org 36286 (corifollitropin alfa) in people with In Vitro Fertilization, run by Organon and Co.
Trial summary
To evaluate the induction of multiple follicular growth after single dose administration of 100 μg or 150 μg Org 36286 in a long protocol of GnRH agonist. Read more about this study
- Who is it for?
- Ages 18 to 39 years, women only
- Conditions the study is for
- In Vitro Fertilization
- What is being tested?
- Org 36286 (corifollitropin alfa)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 9 Dec 2005to 11 Jul 2007
- 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 controlled ovarian stimulation (COS) and IVF or ICSI that have had at least one previous COS cycle with proven normal ovarian response;
- >=18 and <= 39 years of age at the time of signing informed consent;
- a. First group: Body weight >= 50 kg and BMI >= 18 and <= 29 kg/m^2; b. Second group: Body weight <= 60 kg and BMI <= 29 kg/m^2;
- Normal menstrual cycle length: 24-35 days;
- Ejaculatory sperm (use of donated and/or cryopreserved sperm is allowed);
- Normal routine diagnostic hysteroscopy and endometrial biopsy;
- Willing and able to sign informed consent.
Who cannot join
- History of or any current (treated) endocrine abnormality;
- History of ovarian hyper-response1 or history of ovarian hyperstimulation
- syndrome (OHSS);
- History of or current polycystic ovary syndrome (PCOS);
- A basal antral follicle count > 20 (size < 11 mm, both ovaries combined) on USS during the early follicular phase (menstrual cycle day 2-5);
- Less than 2 ovaries or any other ovarian abnormality;
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- Presence of unilateral or bilateral hydrosalpinx (visible on USS);
- Presence of unilateral or bilateral endometriomas (>10 mm; visible on USS);
- More than three unsuccessful COS cycles since the last established ongoing
- pregnancy (if applicable);
- History of non- or low ovarian response to FSH/hMG treatment;
- FSH or LH > 12 IU/L as measured by the local laboratory (sample taken during the early follicular phase: menstrual cycle day 2-5);
- Any clinically relevant abnormal laboratory value based on a sample taken during the screening phase;
- Contraindications for the use of gonadotropins (e.g. tumors, pregnancy/lactation, undiagnosed vaginal bleeding, hypersensitivity, ovarian cysts) or GnRH analogues (e.g. hypersensitivity, pregnancy/lactation);
- Recent history of or current epilepsy, diabetes or cardiovascular, gastro-intestinal, hepatic, renal or pulmonary disease;
- History or 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 screening;
- Administration of investigational drugs within three months prior to signing
- informed consent.
About this study
Official title: A Phase II, Uncontrolled Pilot Trial to Evaluate That a Single Dose of 100 μg or 150 μg Org 36286 (Corifollitropin Alfa) is Able to Induce Multiple Follicular Growth During the First Week of Controlled Ovarian Stimulation for IVF or ICSI Using a Long Protocol of GnRH Agonist (Study 38833)
To evaluate the induction of multiple follicular growth after single dose administration of 100 μg or 150 μg Org 36286 in a long protocol of GnRH agonist.
Read the detailed description
In this trial, all subjects were (pre)treated daily with subcutaneous triptorelin, a GnRH agonist which is known to provide profound suppression of endogenous LH and FSH. It was evaluated whether these down-regulated subjects show an appropriate ovarian response to 100 μg or 150 μg Org 36286 during the first week of stimulation. To evaluate this, follicular growth was measured by USS, and serum inhibin-B and E2 levels were assessed.
- Conditions
- In Vitro Fertilization
- Being tested
- Org 36286 (corifollitropin alfa)
- Keywords
- Infertility, Pharmacological effects of drugs, Drug therapy, Hormones, GnRH agonist, RecFSH, Corifollitropin alfa, Open-label
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Org 36286 (corifollitropin alfa)Drug
Also called corifollitropin alfa
A single dose of Org 36286 will be administered after down-regulation has been confirmed (E2 below 50 ng/L and P below 1.48 μg/L). The first group comprising subjects weighing >= 50 kg will receive a dose of 150 μg Org 36286 (150 μg dose group). The second group comprising subjects weighing <= 60 kg will receive a dose of 100 μg Org 36286 (100 μg dose group).
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | 150 µg Org 36286 (corifollitropin alfa) Receives: Drug: Org 36286 (corifollitropin alfa) |
| Arm 2 | Experimental | 100 µg Org 36286 (corifollitropin alfa) Receives: Drug: Org 36286 (corifollitropin alfa) |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum inhibin-B levels; follicle number and follicle size distribution
Measured: One cycle
Secondary outcomes (2)
Amount of recFSH needed from Stimulation Day 8 onwards to the Day of hCG; Endocrinological parameters (FSH, LH, E2, P); Number and quality of oocytes retrieved
Measured: One cycle
Number of fertilized oocytes; Fertilization rate; Number and quality of embryos; Implantation rate; Miscarriage rate; Clinical outcome
Measured: One cycle
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 start9 Dec 2005
- Primary completion26 Mar 2007
- Study completion11 Jul 2007
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 In Vitro 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 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
- NCT00702351
- Sponsor's protocol ID
- P05788
- Other IDs
- EudraCT #: 2004-004968-68;, 38833
- Acronym
- Realize
- Status last verified
- Feb 2022
- First submitted
- 18 Jun 2008
- Last updated
- 2 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Fatemi HM, Oberye J, Popovic-Todorovic B, Witjes H, Mannaerts B, Devroey P. Corifollitropin alfa in a long GnRH agonist protocol: proof of concept trial. Fertil Steril. 2010 Oct;94(5):1922-4. doi: 10.1016/j.fertnstert.2009.12.070. Epub 2010 Feb 10.
PubMed 20149360
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Uncontrolled Pilot Trial to Evaluate That a Single Dose of 100 μg or 150 μg Org 36286 (Corifollitropin Alfa) is Able to Induce Multiple Follicular Growth During the First Week of Controlled Ovarian Stimulation for IVF or ICSI Using a Long Protocol of GnRH Agonist (Study 38833)
- ClinicalTrials.gov ID
- NCT00702351
- Acronym / sponsor ID
- Realize / P05788
- Conditions
- In Vitro Fertilization
- Keywords
- Infertility, Pharmacological effects of drugs, Drug therapy, Hormones, GnRH agonist, RecFSH, Corifollitropin alfa, Open-label
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- 9 Dec 2005 (actual)
- Primary completion
- 26 Mar 2007 (actual)
- Study completion
- 11 Jul 2007 (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.
To evaluate the induction of multiple follicular growth after single dose administration of 100 μg or 150 μg Org 36286 in a long protocol of GnRH agonist.
Detailed description
In this trial, all subjects were (pre)treated daily with subcutaneous triptorelin, a GnRH agonist which is known to provide profound suppression of endogenous LH and FSH. It was evaluated whether these down-regulated subjects show an appropriate ovarian response to 100 μg or 150 μg Org 36286 during the first week of stimulation. To evaluate this, follicular growth was measured by USS, and serum inhibin-B and E2 levels were assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Org 36286 (corifollitropin alfa)150 µg Org 36286 (corifollitropin alfa) |
| Arm 2 | Experimental | Drug: Org 36286 (corifollitropin alfa)100 µg Org 36286 (corifollitropin alfa) |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Females of couples with an indication for controlled ovarian stimulation (COS) and IVF or ICSI that have had at least one previous COS cycle with proven normal ovarian response;
- >=18 and <= 39 years of age at the time of signing informed consent;
- a. First group: Body weight >= 50 kg and BMI >= 18 and <= 29 kg/m^2; b. Second group: Body weight <= 60 kg and BMI <= 29 kg/m^2;
- Normal menstrual cycle length: 24-35 days;
- Ejaculatory sperm (use of donated and/or cryopreserved sperm is allowed);
Key exclusion criteria (20 listed)
- History of or any current (treated) endocrine abnormality;
- History of ovarian hyper-response1 or history of ovarian hyperstimulation
- syndrome (OHSS);
- History of or current polycystic ovary syndrome (PCOS);
- A basal antral follicle count > 20 (size < 11 mm, both ovaries combined) on USS during the early follicular phase (menstrual cycle day 2-5);
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 36286 (corifollitropin alfa)Also: corifollitropin alfaA single dose of Org 36286 will be administered after down-regulation has been confirmed (E2 below 50 ng/L and P below 1.48 μg/L). The first group comprising subjects weighing >= 50 kg will receive a dose of 150 μg Org 36286 (150 μg dose group). The second group comprising subjects weighing <= 60 kg will receive a dose of 100 μg Org 36286 (100 μg dose group). | Drug | Arm 1, Arm 2 |
Primary outcome
serum inhibin-B levels; follicle number and follicle size distribution
Time frame: One cycle
2 secondary outcomes
Amount of recFSH needed from Stimulation Day 8 onwards to the Day of hCG; Endocrinological parameters (FSH, LH, E2, P); Number and quality of oocytes retrieved
Time frame: One cycle
Number of fertilized oocytes; Fertilization rate; Number and quality of embryos; Implantation rate; Miscarriage rate; Clinical outcome
Time frame: One 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 2 Feb 2022.
- Results publication: PubMed 20149360Fatemi HM, Oberye J, Popovic-Todorovic B, Witjes H, Mannaerts B, Devroey P. Corifollitropin alfa in a long GnRH agonist protocol: proof of concept trial. Fertil Steril. 2010 Oct;94(5):1922-4. doi: 10.1016/j.fertnstert.2009.12.070. Epub 2010 Feb 10.
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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 (corifollitropin alfa) in people with 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 7 inclusion and 20 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 2 Feb 2022. 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?
serum inhibin-B levels; follicle number and follicle size distribution (time frame: One 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 NCT00702351, 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 2 Feb 2022.