Fertility DisordersNCT03816670
Prospective Randomized Trial Comparing Corifollitropin-alfa Late Start vs. Corifollitropin-alfa Standard Start in Expected Poor, Normal and High-responders Undergoing IVF
A study testing Corifollitropin Alfa in people with Fertility Disorders, run by University of Turin, Italy at 1 site in Italy.
Trial summary
To compare the number of retrieved oocytes in the late start CF-alfa (day 4) versus standard CF-alfa protocols (day 2) in patients undergoing IVF. The primary analysis will be also performed in specific subgroups of patients: expected poor-responders, expected normal responders and expected hyper-responders Read more about this study
- Who is it for?
- Ages 18 to 43 years, women only
- Conditions the study is for
- Fertility Disorders
- What is being tested?
- Corifollitropin Alfa
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 1 siteItaly
- Study dates
- 1 Apr 2017to 31 Dec 2018
- Phase
- Interventional
- 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 43 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- aged 18- 43 years
- Male or tubal infertility with indication for IVF treatment
- No PCOS
- No previous IVF treatments in the past two months
- No history of previous Ovarian Hyperstimulation Syndrome (OHSS)
- No previous IVF cycle with more than 30 growing follicles ≥ 11 mm
- Antral Follicle Count (AFC) <20
- No ovarian cyst nor malignant ovarian tumour, breast, uterus or central nervous cancer
Who cannot join
- AMH < 0.2 ng/ml
- Età > 43 anni
Trial locations and contacts
1 site in 1 country.
Italy1 site
Physiopathology of Reproduction and IVF Unit, S. Anna Hospital
Torino, 10126
About this study
Official title: Prospective Randomized Trial Comparing Corifollitropin-alfa Late Start (Day 4) vs. Corifollitropin-alfa Standard Start (Day 2) in Expected Poor, Normal and High-responders Undergoing IVF/ICSI
To compare the number of retrieved oocytes in the late start CF-alfa (day 4) versus standard CF-alfa protocols (day 2) in patients undergoing IVF. The primary analysis will be also performed in specific subgroups of patients: expected poor-responders, expected normal responders and expected hyper-responders
Read the detailed description
The investigators hypothesize that:
- CF-alfa late start (day 4) will show comparable efficacy in terms of number of retrieved oocytes versus standard CF-alfa (day 2) protocol. In certain groups of patients, CF-alfa late start might show differences in terms of efficacy such as in poor-responder patients.
- CF-alfa late start (day 4) will obtain similar results in terms of vital pregnancy rates with a similar safety profile with respect to COS performed using CF-alfa standard administration (day 2) in expected normal, poor, or high responders.
- Oocytes and embryos obtained using CF-alfa late start will have comparable morphological features and development potential than those obtained with CF-alfa standard.
- The patients' satisfaction will possibly be higher using CF-alfa late start than with CF-alfa standard expecially in those patients who will not have the need to add further daily recFSH injections
- Conditions
- Fertility Disorders
- Being tested
- Corifollitropin Alfa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corifollitropin AlfaDrug
late start (day 4) vs. corifollitropin-alfa standard start (day 2)
| Study group | Role | What they receive |
|---|---|---|
| poor responders day 2 | Experimental | "poor responders" women stimulated with CF from day 2 of menstrual cycle Receives: Drug: Corifollitropin Alfa |
| poor responders day 4 | Experimental | "poor responders" women stimulated with CF from day 4 of menstrual cycle Receives: Drug: Corifollitropin Alfa |
| normal responders day 2 | Experimental | "normal responders" women stimulated with CF from day 2 Receives: Drug: Corifollitropin Alfa |
| normal responders day 4 | Experimental | "normal responders" women stimulated with CF from day 4 Receives: Drug: Corifollitropin Alfa |
| high responders day 2 | Experimental | "high responders" women stimulated with CF from day 2 Receives: Drug: Corifollitropin Alfa |
| high responders day 4 | Experimental | "high responders" women stimulated with CF from day 4 Receives: Drug: Corifollitropin Alfa |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of retrieved oocytes
To compare the number of retrieved oocytes in the late start CF-alfa (day 4) versus standard CF-alfa protocols (day 2) in patients undergoing IVF
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2019
- Study start1 Apr 2017
- Primary completion30 Apr 2018
- Study completion31 Dec 2018
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 Fertility DisordersStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alberto Revelli, University of Turin, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03816670
- Sponsor's protocol ID
- IIS#53736
- Status last verified
- Jan 2019
- First submitted
- 22 Jan 2019
- Last updated
- 25 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Revelli A, Gennarelli G, Sestero M, Canosa S, Carosso A, Salvagno F, Pittatore G, Filippini C, Benedetto C. A prospective randomized trial comparing corifollitropin-alpha late-start (day 4) versus standard administration (day 2) in expected poor, normal, and high responders undergoing controlled ovarian stimulation for IVF. J Assist Reprod Genet. 2020 May;37(5):1163-1170. doi: 10.1007/s10815-020-01742-5. Epub 2020 Mar 18.
PubMed 32185595
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Trial Comparing Corifollitropin-alfa Late Start (Day 4) vs. Corifollitropin-alfa Standard Start (Day 2) in Expected Poor, Normal and High-responders Undergoing IVF/ICSI
- ClinicalTrials.gov ID
- NCT03816670
- Acronym / sponsor ID
- IIS#53736
- Conditions
- Fertility Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 25 Jan 2019 (actual)
- 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 compare the number of retrieved oocytes in the late start CF-alfa (day 4) versus standard CF-alfa protocols (day 2) in patients undergoing IVF. The primary analysis will be also performed in specific subgroups of patients: expected poor-responders, expected normal responders and expected hyper-responders
Detailed description
The investigators hypothesize that:
- CF-alfa late start (day 4) will show comparable efficacy in terms of number of retrieved oocytes versus standard CF-alfa (day 2) protocol. In certain groups of patients, CF-alfa late start might show differences in terms of efficacy such as in poor-responder patients.
- CF-alfa late start (day 4) will obtain similar results in terms of vital pregnancy rates with a similar safety profile with respect to COS performed using CF-alfa standard administration (day 2) in expected normal, poor, or high responders.
- Oocytes and embryos obtained using CF-alfa late start will have comparable morphological features and development potential than those obtained with CF-alfa standard.
- The patients' satisfaction will possibly be higher using CF-alfa late start than with CF-alfa standard expecially in those patients who will not have the need to add further daily recFSH injections
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| poor responders day 2 | Experimental | Drug: Corifollitropin Alfa"poor responders" women stimulated with CF from day 2 of menstrual cycle |
| poor responders day 4 | Experimental | Drug: Corifollitropin Alfa"poor responders" women stimulated with CF from day 4 of menstrual cycle |
| normal responders day 2 | Experimental | Drug: Corifollitropin Alfa"normal responders" women stimulated with CF from day 2 |
| normal responders day 4 | Experimental | Drug: Corifollitropin Alfa"normal responders" women stimulated with CF from day 4 |
| high responders day 2 | Experimental | Drug: Corifollitropin Alfa"high responders" women stimulated with CF from day 2 |
| high responders day 4 | Experimental | Drug: Corifollitropin Alfa"high responders" women stimulated with CF from day 4 |
Who may qualify
- Ages
- 18 to 43 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- aged 18- 43 years
- Male or tubal infertility with indication for IVF treatment
- No PCOS
- No previous IVF treatments in the past two months
- No history of previous Ovarian Hyperstimulation Syndrome (OHSS)
Key exclusion criteria (2 listed)
- AMH < 0.2 ng/ml
- Età > 43 anni
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 Alfalate start (day 4) vs. corifollitropin-alfa standard start (day 2) | Drug | high responders day 2, high responders day 4, normal responders day 2, normal responders day 4, poor responders day 2, poor responders day 4 |
Primary outcome
number of retrieved oocytes
Time frame: 1 year
To compare the number of retrieved oocytes in the late start CF-alfa (day 4) versus standard CF-alfa protocols (day 2) in patients undergoing IVF
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 25 Jan 2019.
- Derived from this study: PubMed 32185595Revelli A, Gennarelli G, Sestero M, Canosa S, Carosso A, Salvagno F, Pittatore G, Filippini C, Benedetto C. A prospective randomized trial comparing corifollitropin-alpha late-start (day 4) versus standard administration (day 2) in expected poor, normal, and high responders undergoing controlled ovarian stimulation for IVF. J Assist Reprod Genet. 2020 May;37(5):1163-1170. doi: 10.1007/s10815-020-01742-5. Epub 2020 Mar 18.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Corifollitropin Alfa in people with Fertility Disorders, run by University of Turin, Italy at 1 site in Italy.
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 8 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 25 Jan 2019. 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 Italy. 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.
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 retrieved oocytes (time frame: 1 year). 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 NCT03816670, 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 25 Jan 2019.