InfertilityPhase 4PE-PMANCT04695483
Reduction of Progesterone Elevation at Trigger in POR After Long Acting COS Compared With Daily COS: a Prospective Randomized Trial
A Phase 4 study testing Corifollitropin alfa and Follitropin Beta in people with Infertility, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
The overarching objective of this research is to generate clinical evidence to argue the benefits of long acting stimulation protocol compared to the daily stimulation protocol in poor ovarian responder bologna' criteria patients after controlled ovarian stimulation. Read more about this study
- Who is it for?
- Ages 25 to 42 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Corifollitropin alfa and Follitropin Beta
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteItaly
- Study dates
- 22 Feb 2022to 6 May 2024
- 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 25 to 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Indication to IVF treatment
- Normal BMI (18.5-24.9 kg/m2)
- AMH level < 1.1 ng/ml and/or AFC < 5 follicles and/or < 3 oo-cytes retrieved in previous cycle
- Regular menstrual cycles
- Signed informed consent
Who cannot join
- Freeze all cycles for abnormal bleeding
- PCOS
- History of untreated autoimmune
- Endocrine or metabolic disorders
- Ovarian cystectomy or oophorectomy
- FSH ≥ 20 lU/L
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reduction of Progesterone Elevation at Trigger in Poor Responder Bologna' Criteria Patients After Controlled Ovarian Stimulation With Long Acting Standard Stimulation Protocol Compared With Conventional Daily Protocol: a Single Center Prospective Randomized Fase IV Trial
The overarching objective of this research is to generate clinical evidence to argue the benefits of long acting stimulation protocol compared to the daily stimulation protocol in poor ovarian responder bologna' criteria patients after controlled ovarian stimulation. Reduction in the proportion of subjects with progesterone > 1.1 ng/ml on the day of triggering (day + 13) in the experimental group compared to the control group is expected.
Read the detailed description
Each patient will receive a first visit for infertility where will be collected subject history and baseline information, and meet all the inclusion / exclusion criteria. Eligible patients who agreed to participate will be randomized to either long acting standard COS with corifollitropin alpha or standard COS with daily FSH in a fixed GnRH antagonist protocol. All patients will be allowed to participate in the study only once and a written informed consent will be obtained from all, following consultation and before the initiation of the treatment.
The endocrine profile of all the patients will be evaluated by analysis of serum progesterone, 17b-estradiol (E2), FSH and LH at different time points: basal condition, during stimulation, at the hCG day and at pick-up.
Transvaginal follicular aspiration will be performed by ultrasound guidance 36 hours after hCG administration. The day of pick up oocytes will be fertilized with partner's semen; after 3-5 days, on the base of its evolution, embryo will be transferred. 14 days after embryo-transfer a preg-nancy test will be performed. Follow up in case of obtained pregnancy will be done until 20 weeks of gestation and considered as ongoing pregnancy.
The entire duration of the study is 24 months, the follow up of the last patients enrolled will be 6 months.
- Conditions
- Infertility
- Being tested
- Corifollitropin alfa, Follitropin Beta
- 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
Controlled ovarian stimulation long-acting protocol
Follitropin BetaDrug
Daily controlled ovarian stimulation protocol
| Study group | Role | What they receive |
|---|---|---|
| Corifollitropin alpha group | Experimental | Patients treated with Corifollitropin-alpha in a long-acting controlled ovarian stimulation Receives: Drug: Corifollitropin alfa; Drug: Follitropin Beta |
| FSH group | Active comparator | Patients treated with Follitropin beta in a daily controlled ovarian stimulation protocol Receives: Drug: Follitropin Beta |
What is being measured
The primary outcome is the main question the study is designed to answer.
Premature progesterone elevation
Progesterone > or equal to 1.1 ng/mL at day of trigger
Measured: day 12
Secondary outcomes (6)
Percentage of freeze-all cycles due to premature progesterone elevation
Measured: day 12
Number of oocytes collected at ovum retrieval
Measured: day 14
Fertilization rate
Percentage of oocytes fertilized
Measured: day 15
Number of embryos available
Measured: Day 17
Pregnancy rate
Beta-HCG positive
Measured: day 30
Ongoing pregnancy
Vital fetus at 20 weeks of gestation
Measured: Up to 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start22 Feb 2022
- Primary completion19 Jan 2024
- Study completion6 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enrico Papaleo, IRCCS San Raffaele
- Investigators
- Enrico Papaleo, MD, Principal investigator, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04695483
- Sponsor's protocol ID
- PE-PMA
- Other IDs
- 2020-004329-21
- Acronym
- PE-PMA
- Status last verified
- May 2024
- First submitted
- 1 Dec 2020
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Progesterone Elevation at Trigger in Poor Responder Bologna' Criteria Patients After Controlled Ovarian Stimulation With Long Acting Standard Stimulation Protocol Compared With Conventional Daily Protocol: a Single Center Prospective Randomized Fase IV Trial
- ClinicalTrials.gov ID
- NCT04695483
- Acronym / sponsor ID
- PE-PMA / PE-PMA
- Conditions
- Infertility
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 22 Feb 2022 (actual)
- Primary completion
- 19 Jan 2024 (actual)
- Study completion
- 6 May 2024 (actual)
- First posted
- 5 Jan 2021 (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.
The overarching objective of this research is to generate clinical evidence to argue the benefits of long acting stimulation protocol compared to the daily stimulation protocol in poor ovarian responder bologna' criteria patients after controlled ovarian stimulation. Reduction in the proportion of subjects with progesterone > 1.1 ng/ml on the day of triggering (day + 13) in the experimental group compared to the control group is expected.
Detailed description
Each patient will receive a first visit for infertility where will be collected subject history and baseline information, and meet all the inclusion / exclusion criteria. Eligible patients who agreed to participate will be randomized to either long acting standard COS with corifollitropin alpha or standard COS with daily FSH in a fixed GnRH antagonist protocol. All patients will be allowed to participate in the study only once and a written informed consent will be obtained from all, following consultation and before the initiation of the treatment.
The endocrine profile of all the patients will be evaluated by analysis of serum progesterone, 17b-estradiol (E2), FSH and LH at different time points: basal condition, during stimulation, at the hCG day and at pick-up.
Transvaginal follicular aspiration will be performed by ultrasound guidance 36 hours after hCG administration. The day of pick up oocytes will be fertilized with partner's semen; after 3-5 days, on the base of its evolution, embryo will be transferred. 14 days after embryo-transfer a preg-nancy test will be performed. Follow up in case of obtained pregnancy will be done until 20 weeks of gestation and considered as ongoing pregnancy.
The entire duration of the study is 24 months, the follow up of the last patients enrolled will be 6 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Corifollitropin alpha group | Experimental | Drug: Corifollitropin alfa, Drug: Follitropin BetaPatients treated with Corifollitropin-alpha in a long-acting controlled ovarian stimulation |
| FSH group | Active comparator | Drug: Follitropin BetaPatients treated with Follitropin beta in a daily controlled ovarian stimulation protocol |
Who may qualify
- Ages
- 25 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Indication to IVF treatment
- Normal BMI (18.5-24.9 kg/m2)
- AMH level < 1.1 ng/ml and/or AFC < 5 follicles and/or < 3 oo-cytes retrieved in previous cycle
- Regular menstrual cycles
- Signed informed consent
Key exclusion criteria (6 listed)
- Freeze all cycles for abnormal bleeding
- PCOS
- History of untreated autoimmune
- Endocrine or metabolic disorders
- Ovarian cystectomy or oophorectomy
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 alfaControlled ovarian stimulation long-acting protocol | Drug | Corifollitropin alpha group |
| Follitropin BetaDaily controlled ovarian stimulation protocol | Drug | Corifollitropin alpha group, FSH group |
Primary outcome
Premature progesterone elevation
Time frame: day 12
Progesterone > or equal to 1.1 ng/mL at day of trigger
6 secondary outcomes
Percentage of freeze-all cycles due to premature progesterone elevation
Time frame: day 12
Number of oocytes collected at ovum retrieval
Time frame: day 14
Fertilization rate
Time frame: day 15
Number of embryos available
Time frame: Day 17
Pregnancy rate
Time frame: day 30
Ongoing pregnancy
Time frame: Up to 20 weeks
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 16 May 2024.
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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.
Enrico Papaleo, MD principal investigator
IRCCS San Raffaele
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 Follitropin Beta in people with Infertility, run by IRCCS San Raffaele 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 5 inclusion and 6 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 16 May 2024. 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.
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?
Premature progesterone elevation (time frame: day 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 May 2024.