SubfertilityPhase 4NCT02046655
Corifollitropin Alfa Compared to Daily rFSH in Poor Responders Undergoing ICSI
A Phase 4 study testing Corifollitropin alfa and rFSH in people with Subfertility, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial summary
Corifollitropin alfa has been shown to result in significantly more oocytes compared to daily recombinant follicle stimulating hormone (recFSH) (Devroey et al., 2009), probably due to the higher circulating FSH activity during the first days of stimulation. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Subfertility
- What is being tested?
- Corifollitropin alfa and rFSH
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteGreece
- Study dates
- Jan 2011to Mar 2014
- Phase
- Phase 4
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Proven poor responders of couples with an indication for COS
- ≥ 18 and < 45 years of age
- BMI ≥ 18 and ≤ 32 kg/m2
- Regular spontaneous menstrual cycle (24-35 days)
- Availability of ejaculatory sperm (use of donated and/or cryo-preserved sperm is allowed)
Who cannot join
- PGD or PGS
- TESE
Trial locations and contacts
1 site in 1 country.
Greece1 site
Unit for Human Reproduction, 1st Dept of Obstetrics and Gynaecology, Medical School, Aristotle University of Thessaloniki
Thessaloniki
About this study
Official title: Corifollitropin Alfa Compared to Daily Rec FSH in Poor Responders Undergoing ICSI Using a GnRH Antagonist Protocol
Corifollitropin alfa has been shown to result in significantly more oocytes compared to daily recombinant follicle stimulating hormone (recFSH) (Devroey et al., 2009), probably due to the higher circulating FSH activity during the first days of stimulation. For this reason, the use of corifollitropin alfa might be beneficial in poor responders in whom the number of oocytes retrieved is crucial for success.
The purpose of this study is to evaluate the effectiveness of corifollitropin alfa treatment compared to daily recFSH in terms of the number of oocytes retrieved in a defined population of poor responder patients undergoing intracytoplasmic sperm injection (ICSI) using gonadotrophin releasing hormone (GnRH) antagonists.
- Conditions
- Subfertility
- Being tested
- Corifollitropin alfa, rFSH
- 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
Also called Elonva
rFSHDrug
Also called Puregon
| Study group | Role | What they receive |
|---|---|---|
| Corifollitropin alfa group | Experimental | On day 2 of the cycle, a single subcutaneous (SC) dose of 150 μg Corifollitropin alfa (Elonva) will be administered.
GnRH antagonist (Orgalutran) 0.25 mg/day flexible initiation by a follicle of 14mm.
A daily dose of recFSH (450 IU/day) will be used from day 8 of stimulation until the day of hCG, if necessary.
Triggering of final oocyte maturation will be performed using 250 μg of rechCG. Receives: Drug: Corifollitropin alfa |
| rec FSH group | Active comparator | On day 2 of the cycle, daily SC dose of min 450 IU recFSH (Puregon) will be administered.
GnRH antagonist (Orgalutran) 0.25 mg/day , flexible initiation by a follicle of 14mm.
Triggering of final oocyte maturation will be performed using 250 μg of rechCG. Receives: Drug: rFSH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total number of retrieved oocytes
Measured: 36 h after human chorionic gonadotrophin (hCG) administration
Secondary outcomes (2)
Clinical pregnancy rate (evidence of intrauterine sac with fetal heart activity at 6-8 weeks of gestation)
Measured: At 6-8 weeks of gestation
Number of embryos transferred
Measured: 2 days following oocyte retrieval
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2014 (estimated)
- Study startJan 2011
- Primary completionMar 2014
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 SubfertilityStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, E.M. Kolibianakis, Aristotle University Of Thessaloniki
- Investigators
- Efstratios M Kolibianakis, MD, MSc, PhD, Principal investigator, Unit for Human Reproduction, 1st Dept. of Obstetrics and Gynaecology, Medical School, Aristotle University of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02046655
- Sponsor's protocol ID
- UHR-11
- Status last verified
- May 2014
- First submitted
- 18 Dec 2013
- Last updated
- 14 May 2014
- Results posted
- No
Publications
Kolibianakis EM, Venetis CA, Bosdou JK, Zepiridis L, Chatzimeletiou K, Makedos A, Masouridou S, Triantafillidis S, Mitsoli A, Tarlatzis BC. Corifollitropin alfa compared with follitropin beta in poor responders undergoing ICSI: a randomized controlled trial. Hum Reprod. 2015 Feb;30(2):432-40. doi: 10.1093/humrep/deu301. Epub 2014 Dec 9.
PubMed 25492411
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Corifollitropin Alfa Compared to Daily Rec FSH in Poor Responders Undergoing ICSI Using a GnRH Antagonist Protocol
- ClinicalTrials.gov ID
- NCT02046655
- Acronym / sponsor ID
- UHR-11
- Conditions
- Subfertility
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Mar 2014 (actual)
- First posted
- 28 Jan 2014 (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.
Corifollitropin alfa has been shown to result in significantly more oocytes compared to daily recombinant follicle stimulating hormone (recFSH) (Devroey et al., 2009), probably due to the higher circulating FSH activity during the first days of stimulation. For this reason, the use of corifollitropin alfa might be beneficial in poor responders in whom the number of oocytes retrieved is crucial for success.
The purpose of this study is to evaluate the effectiveness of corifollitropin alfa treatment compared to daily recFSH in terms of the number of oocytes retrieved in a defined population of poor responder patients undergoing intracytoplasmic sperm injection (ICSI) using gonadotrophin releasing hormone (GnRH) antagonists.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Corifollitropin alfa group | Experimental | Drug: Corifollitropin alfaOn day 2 of the cycle, a single subcutaneous (SC) dose of 150 μg Corifollitropin alfa (Elonva) will be administered. GnRH antagonist (Orgalutran) 0.25 mg/day flexible initiation by a follicle of 14mm. A daily dose of recFSH (450 IU/day) will be used from day 8 of stimulation until the day of hCG, if necessary. Triggering of final oocyte maturation will be performed using 250 μg of rechCG. |
| rec FSH group | Active comparator | Drug: rFSHOn day 2 of the cycle, daily SC dose of min 450 IU recFSH (Puregon) will be administered. GnRH antagonist (Orgalutran) 0.25 mg/day , flexible initiation by a follicle of 14mm. Triggering of final oocyte maturation will be performed using 250 μg of rechCG. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Proven poor responders of couples with an indication for COS
- ≥ 18 and < 45 years of age
- BMI ≥ 18 and ≤ 32 kg/m2
- Regular spontaneous menstrual cycle (24-35 days)
- Availability of ejaculatory sperm (use of donated and/or cryo-preserved sperm is allowed)
Key exclusion criteria (2 listed)
- PGD or PGS
- TESE
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: Elonva | Drug | Corifollitropin alfa group |
| rFSHAlso: Puregon | Drug | rec FSH group |
Primary outcome
Total number of retrieved oocytes
Time frame: 36 h after human chorionic gonadotrophin (hCG) administration
2 secondary outcomes
Clinical pregnancy rate (evidence of intrauterine sac with fetal heart activity at 6-8 weeks of gestation)
Time frame: At 6-8 weeks of gestation
Number of embryos transferred
Time frame: 2 days following oocyte retrieval
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 14 May 2014.
- Derived from this study: PubMed 25492411Kolibianakis EM, Venetis CA, Bosdou JK, Zepiridis L, Chatzimeletiou K, Makedos A, Masouridou S, Triantafillidis S, Mitsoli A, Tarlatzis BC. Corifollitropin alfa compared with follitropin beta in poor responders undergoing ICSI: a randomized controlled trial. Hum Reprod. 2015 Feb;30(2):432-40. doi: 10.1093/humrep/deu301. Epub 2014 Dec 9.
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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.
Efstratios M Kolibianakis, MD, MSc, PhD principal investigator
Unit for Human Reproduction, 1st Dept. of Obstetrics and Gynaecology, Medical School, Aristotle University of Thessaloniki
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Corifollitropin alfa and rFSH in people with Subfertility, run by Aristotle University Of Thessaloniki at 1 site 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 5 inclusion and 2 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 14 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Total number of retrieved oocytes (time frame: 36 h after human chorionic gonadotrophin (hCG) administration). 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 NCT02046655, 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 14 May 2014.