InfertilityPhase 1/2NCT01319695
Corifollitropin Alfa Versus Recombinant Follicle Stimulating Hormone (FSH) in Ovarian Stimulation of Women Undergoing in Vitro Fertilisation
A Phase 1/2 study testing corifollitropin alfa and recombinant follicle stimulating hormone (FSH) in people with Infertility, run by National and Kapodistrian University of Athens at 2 sites in Greece.
Trial summary
The use of corifollitropin alfa is superior in terms of pregnancy outcome parameters as compared to recombinant follicle stimulating hormone (FSH) during ovarian stimulation protocols in women undergoing in vitro fertilisation. Read more about this study
- Who is it for?
- Ages 18 to 36 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- corifollitropin alfa and recombinant follicle stimulating hormone (FSH)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 2 sitesGreece
- Study dates
- Jan 2011to Aug 2017
- Phase
- Phase 1/2
- 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 36 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women aged 18-36 years old with a body weight of more than 60 kg up to 90 kg
- BMI of 18-32 kg/m2
- Menstrual cycle length of 23-35 days
- An indication for controlled ovarian stimulation for IVF or ICSI
Who cannot join
- history of an endocrine abnormality
- abnormal outcome of blood biochemistry or hematology
- abnormal cervical smear
- chronic disease
- uterine pathology that interfering with the COS treatment (e.g. fibroids ≥ 5 cm)
Trial locations and contacts
2 sites in 1 country.
Greece2 sites
3rd Department of Obstetrics and Gynecology, Assisted Reproduction Unit
Athens, Chaidari, 12462
Attikon University Hospital
Athens, Chaidari, 12642
About this study
The use of corifollitropin alfa is superior in terms of pregnancy outcome parameters as compared to recombinant follicle stimulating hormone (FSH) during ovarian stimulation protocols in women undergoing in vitro fertilisation.
- Conditions
- Infertility
- Being tested
- corifollitropin alfa, recombinant follicle stimulating hormone (FSH)
- Keywords
- corifollitropin alfa, FSH ovarian stimulation, IVF
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
corifollitropin alfaDrug
100 microg for a group of women weighing <or=60 kg and 150 microg for a group of women weighing >60 kg
recombinant follicle stimulating hormone (FSH)Drug
150-300 IU of the drug daily from day 2 of the menstrual cycle until more than 2 follicles are >18mm
| Study group | Role | What they receive |
|---|---|---|
| corifollitropin alfa | Experimental | Not described Receives: Drug: corifollitropin alfa |
| recombinant follicle stimulating hormone (FSH) | Active comparator | 150-300 IU of FSH for ovarian stimulation in women undergoing IVF Receives: Drug: recombinant follicle stimulating hormone (FSH) |
What is being measured
The primary outcome is the main question the study is designed to answer.
no of oocytes (>2 between groups)
Measured: at egg recovery, through study completion, an average of 2 years
Secondary outcomes (4)
Clinical pregnancy rate cancellation rate miscarriage rate ectopic pregnancy rate
The presence of fetal heart at transvaginal ultrasound at 6+2 gestational weeks
Measured: 3 weeks after embryo transfer
Ongoing pregnancy rate
The presence of fetal heart at ultrasound after 12 gestational weeks
Measured: 12 weeks after embryo transfer
miscarriage rate
Measured: through study completion, an average of 2 years
live birth rate
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2011 (estimated)
- Study startJan 2011
- Primary completionJul 2016
- Study completionAug 2017
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.
- More trials run by National and Kapodistrian University of AthensThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- National and Kapodistrian University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Siristatidis Charalampos, MD, PhD, National and Kapodistrian University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01319695
- Sponsor's protocol ID
- 1234560
- Status last verified
- Apr 2016
- First submitted
- 8 Mar 2011
- Last updated
- 17 Mar 2021
- Results posted
- No
- Individual data sharing
- Undecided: We will be happy to share the data
Publications
Siristatidis C, Dafopoulos K, Christoforidis N, Anifandis G, Pergialiotis V, Papantoniou N. Corifollitropin alfa compared with follitropin beta in GnRH-antagonist ovarian stimulation protocols in an unselected population undergoing IVF/ICSI. Gynecol Endocrinol. 2017 Dec;33(12):968-971. doi: 10.1080/09513590.2017.1323203. Epub 2017 May 16.
PubMed 28508691
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Corifollitropin Alfa Versus Recombinant Follicle Stimulating Hormone (FSH) in Ovarian Stimulation of Women Undergoing in Vitro Fertilisation
- ClinicalTrials.gov ID
- NCT01319695
- Acronym / sponsor ID
- 1234560
- Conditions
- Infertility
- Keywords
- corifollitropin alfa, FSH ovarian stimulation, IVF
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- National and Kapodistrian University of AthensUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jul 2016 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 22 Mar 2011 (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 use of corifollitropin alfa is superior in terms of pregnancy outcome parameters as compared to recombinant follicle stimulating hormone (FSH) during ovarian stimulation protocols in women undergoing in vitro fertilisation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| corifollitropin alfa | Experimental | Drug: corifollitropin alfa |
| recombinant follicle stimulating hormone (FSH) | Active comparator | Drug: recombinant follicle stimulating hormone (FSH)150-300 IU of FSH for ovarian stimulation in women undergoing IVF |
Who may qualify
- Ages
- 18 to 36 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women aged 18-36 years old with a body weight of more than 60 kg up to 90 kg
- BMI of 18-32 kg/m2
- Menstrual cycle length of 23-35 days
- An indication for controlled ovarian stimulation for IVF or ICSI
Key exclusion criteria (5 listed)
- history of an endocrine abnormality
- abnormal outcome of blood biochemistry or hematology
- abnormal cervical smear
- chronic disease
- uterine pathology that interfering with the COS treatment (e.g. fibroids ≥ 5 cm)
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 alfa100 microg for a group of women weighing <or=60 kg and 150 microg for a group of women weighing >60 kg | Drug | corifollitropin alfa |
| recombinant follicle stimulating hormone (FSH)150-300 IU of the drug daily from day 2 of the menstrual cycle until more than 2 follicles are >18mm | Drug | recombinant follicle stimulating hormone (FSH) |
Primary outcome
no of oocytes (>2 between groups)
Time frame: at egg recovery, through study completion, an average of 2 years
4 secondary outcomes
Clinical pregnancy rate cancellation rate miscarriage rate ectopic pregnancy rate
Time frame: 3 weeks after embryo transfer
Ongoing pregnancy rate
Time frame: 12 weeks after embryo transfer
miscarriage rate
Time frame: through study completion, an average of 2 years
live birth rate
Time frame: through study completion, an average of 2 years
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 17 Mar 2021.
- Results publication: PubMed 28508691Siristatidis C, Dafopoulos K, Christoforidis N, Anifandis G, Pergialiotis V, Papantoniou N. Corifollitropin alfa compared with follitropin beta in GnRH-antagonist ovarian stimulation protocols in an unselected population undergoing IVF/ICSI. Gynecol Endocrinol. 2017 Dec;33(12):968-971. doi: 10.1080/09513590.2017.1323203. Epub 2017 May 16.
- Individual participant dataSharing planned: Undecided. We will be happy to share the data
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing corifollitropin alfa and recombinant follicle stimulating hormone (FSH) in people with Infertility, run by National and Kapodistrian University of Athens at 2 sites in Greece.
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 5 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 17 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
no of oocytes (>2 between groups) (time frame: at egg recovery, through study completion, an average of 2 years). 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 NCT01319695, 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 17 Mar 2021.