ProgesteronePROPER-1NCT03734770
Patient's Preferences About Subcutaneous or Vaginal Progesterone Administration for Luteal Phase Support
A study testing Subcutaneous Progesterone and Vaginal progesterone in people with Progesterone and Luteal Phase Support, run by Universita di Verona at 1 site in Italy.
Trial summary
Luteal phase support in "in vitro fertilization" (IVF) cycles has been shown to improve pregnancy rates and became a standard of treatment, and progesterone is the first choice considering its safety profile and effectiveness. Read more about this study
- Who is it for?
- Ages 18 to 43 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Progesterone, Luteal Phase Support, In Vitro Fertilization
- What is being tested?
- Subcutaneous Progesterone and Vaginal progesterone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2019to 1 Jul 2019
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Infertile women candidate to undergo fresh IVF cycles
Who cannot join
- day-3 follicle-stimulating hormone (FSH) levels over 15 IU/L
- clinically relevant systemic disease (e.g., uncontrolled thyroid and adrenal dysfunction, an organic intracranial lesion such as a pituitary tumor, insulin-dependent diabetes mellitus, cancers)
- hypersensitivity to any of the study drugs
- contraindications to use the study drugs
- surgical or medical condition that would interfere with absorption, distribution, metabolism, or excretion of the study drugs
Trial locations and contacts
1 site in 1 country.
Italy1 site
AOUI Verona - University of Verona - Department of Obstetrics and Gynecology
Verona, 37125
About this study
Official title: Patient's Preferences About Subcutaneous or Vaginal Progesterone Administration for Luteal Phase Support: Prospective Randomized Trial.
Luteal phase support in "in vitro fertilization" (IVF) cycles has been shown to improve pregnancy rates and became a standard of treatment, and progesterone is the first choice considering its safety profile and effectiveness. There are many studies demonstrating that vaginal progesterone is equally efficacious and better tolerated compared to intramuscular progesterone for luteal phase support in IVF cycles. Conversely, although different studies showed that subcutaneous progesterone is equally efficacious compared to vaginal progesterone, patient use satisfaction and compliance were less studied with few evidences are available, that may guide the choice of vaginal progesterone instead of subcutaneous progesterone and other way around. Considering the paucity of published data about the patient's preference and use satisfaction about subcutaneous progesterone, the investigators will conduct a prospective randomized study aimed to compared adverse effects rates, impact on quality of life, use satisfaction and administration preference in women undergoing luteal phase support with vaginal progesterone versus subcutaneous progesterone during IVF cycles, that may guide the choice for luteal phase support in IVF cycles.
- Conditions
- Progesterone, Luteal Phase Support, In Vitro Fertilization
- Being tested
- Subcutaneous Progesterone, Vaginal progesterone
- Keywords
- progesterone, subcutaneous, vaginal, luteal phase support, in vitro fertilization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subcutaneous ProgesteroneDrug
Subcutaneous progesterone (Pleyris, IBSA Farmaceutici, Italia) 25 mg one time per day (every day at the same time, according to patient's availability and preference).
Vaginal progesteroneDrug
Micronized vaginal progesterone (Progeffik, EFFIK Spa, Italia) 200 mg three times per day (every 8 hours).
| Study group | Role | What they receive |
|---|---|---|
| Subcutaneous progesterone | Active comparator | After standard stimulating protocol for IVF, beginning on the day of oocyte retrieval allocated patients receive subcutaneous progesterone (Pleyris, IBSA Farmaceutici, Italia) 25 mg one time per day (every day at the same time, according to patient's availability and preference) for at least 8 gestational weeks or confirmation of a negative pregnancy test performed 14 days after oocyte retrieval. Receives: Drug: Subcutaneous Progesterone |
| Vaginal progesterone | Active comparator | After standard stimulating protocol for IVF, beginning on the day of oocyte retrieval allocated patients receive micronized vaginal progesterone (Progeffik, EFFIK Spa, Italia) 200 mg three times per day (every 8 hours) for at least 8 gestational weeks or confirmation of a negative pregnancy test performed 14 days after oocyte retrieval. Receives: Drug: Vaginal progesterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grade of use satisfaction reported by the patients
Patients will be asked how satisfied they are by the use of progesterone product that they receive in the luteal phase. Their satisfaction responses will be recorded on a scale of 1 to 3, with 1 being ''least satisfied'' and 3 being ''most satisfied'.
Measured: At the human chorionic gonadotropin test performed after 14 days of progesterone use
Grade of quality of life impairment reported by the patients
Patients will be asked whether work life, social life, sexual life, and personal hygiene are perceived impaired by the progesterone treatment that they received. The answer for each item is "yes" or "no".
Measured: At the human chorionic gonadotropin test performed after 14 days of progesterone use
Adverse effects (AEs)
Patients will be asked to report experienced AEs. The investigated AEs are sleepiness, dizziness, headache, bowel dysfunctions, breast pain/tension, weight changes, mood disorders, skin irritation, and vaginal discharge.
The answer for each item is "yes" or "no".
Measured: At the human chorionic gonadotropin test performed after 14 days of progesterone use
Secondary outcomes (4)
Progesterone administration route that the patients prefer
Patients of subcutaneous progesterone arm and who had previously used vaginal progesterone will be asked which administration route they prefer.
Measured: At the human chorionic gonadotropin test performed after 14 days of progesterone use
Implantation rate
Rate of positive human chorionic gonadotropin test
Measured: At the human chorionic gonadotropin test performed after 14 days of progesterone use
Clinically pregnancy rate
Rate of evolving pregnancy at ultrasound
Measured: At 6 week from oocyte retrieval
live birth rate
Rate of baby delivered after 24 gestational weeks
Measured: At nine months from oocyte retrieval
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2018
- Study start1 Jan 2019
- Primary completion1 Mar 2019
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ProgesteroneStudies 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
- Model description
- Prospective randomized trial
- Masking
- None (open label)
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universita di Verona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simone Garzon, Universita di Verona
- Investigators
- Simone Garzon, M.D., Principal investigator, Universita di VeronaRossana Di Paola, M.D., Principal investigator, Universita di VeronaAntonio Simone Laganà, Principal investigator, Università degli Studi dell'InsubriaFrancesca Parissone, M.D., Principal investigator, Universita di VeronaStefano Zaffagnini, M.D., Study director, AOUI VeronaMassimo Franchi, M.D., Study director, Universita di VeronaRicciarda Raffaelli, M.D., Principal investigator, Universita di Verona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03734770
- Sponsor's protocol ID
- PROPER-1
- Acronym
- PROPER-1
- Status last verified
- May 2022
- First submitted
- 31 Oct 2018
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient's Preferences About Subcutaneous or Vaginal Progesterone Administration for Luteal Phase Support: Prospective Randomized Trial.
- ClinicalTrials.gov ID
- NCT03734770
- Acronym / sponsor ID
- PROPER-1 / PROPER-1
- Conditions
- Progesterone, Luteal Phase Support, In Vitro Fertilization
- Keywords
- progesterone, subcutaneous, vaginal, luteal phase support, in vitro fertilization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Universita di VeronaUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 8 Nov 2018 (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.
Luteal phase support in "in vitro fertilization" (IVF) cycles has been shown to improve pregnancy rates and became a standard of treatment, and progesterone is the first choice considering its safety profile and effectiveness. There are many studies demonstrating that vaginal progesterone is equally efficacious and better tolerated compared to intramuscular progesterone for luteal phase support in IVF cycles. Conversely, although different studies showed that subcutaneous progesterone is equally efficacious compared to vaginal progesterone, patient use satisfaction and compliance were less studied with few evidences are available, that may guide the choice of vaginal progesterone instead of subcutaneous progesterone and other way around. Considering the paucity of published data about the patient's preference and use satisfaction about subcutaneous progesterone, the investigators will conduct a prospective randomized study aimed to compared adverse effects rates, impact on quality of life, use satisfaction and administration preference in women undergoing luteal phase support with vaginal progesterone versus subcutaneous progesterone during IVF cycles, that may guide the choice for luteal phase support in IVF cycles.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective randomized trial
| Arm | Type | Receives |
|---|---|---|
| Subcutaneous progesterone | Active comparator | Drug: Subcutaneous ProgesteroneAfter standard stimulating protocol for IVF, beginning on the day of oocyte retrieval allocated patients receive subcutaneous progesterone (Pleyris, IBSA Farmaceutici, Italia) 25 mg one time per day (every day at the same time, according to patient's availability and preference) for at least 8 gestational weeks or confirmation of a negative pregnancy test performed 14 days after oocyte retrieval. |
| Vaginal progesterone | Active comparator | Drug: Vaginal progesteroneAfter standard stimulating protocol for IVF, beginning on the day of oocyte retrieval allocated patients receive micronized vaginal progesterone (Progeffik, EFFIK Spa, Italia) 200 mg three times per day (every 8 hours) for at least 8 gestational weeks or confirmation of a negative pregnancy test performed 14 days after oocyte retrieval. |
Who may qualify
- Ages
- 18 to 43 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Infertile women candidate to undergo fresh IVF cycles
Key exclusion criteria (5 listed)
- day-3 follicle-stimulating hormone (FSH) levels over 15 IU/L
- clinically relevant systemic disease (e.g., uncontrolled thyroid and adrenal dysfunction, an organic intracranial lesion such as a pituitary tumor, insulin-dependent diabetes mellitus, cancers)
- hypersensitivity to any of the study drugs
- contraindications to use the study drugs
- surgical or medical condition that would interfere with absorption, distribution, metabolism, or excretion of the study drugs
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 |
|---|---|---|
| Subcutaneous ProgesteroneSubcutaneous progesterone (Pleyris, IBSA Farmaceutici, Italia) 25 mg one time per day (every day at the same time, according to patient's availability and preference). | Drug | Subcutaneous progesterone |
| Vaginal progesteroneMicronized vaginal progesterone (Progeffik, EFFIK Spa, Italia) 200 mg three times per day (every 8 hours). | Drug | Vaginal progesterone |
Primary outcome
Grade of use satisfaction reported by the patients
Time frame: At the human chorionic gonadotropin test performed after 14 days of progesterone use
Patients will be asked how satisfied they are by the use of progesterone product that they receive in the luteal phase. Their satisfaction responses will be recorded on a scale of 1 to 3, with 1 being ''least satisfied'' and 3 being ''most satisfied'.
Grade of quality of life impairment reported by the patients
Time frame: At the human chorionic gonadotropin test performed after 14 days of progesterone use
Patients will be asked whether work life, social life, sexual life, and personal hygiene are perceived impaired by the progesterone treatment that they received. The answer for each item is "yes" or "no".
Adverse effects (AEs)
Time frame: At the human chorionic gonadotropin test performed after 14 days of progesterone use
Patients will be asked to report experienced AEs. The investigated AEs are sleepiness, dizziness, headache, bowel dysfunctions, breast pain/tension, weight changes, mood disorders, skin irritation, and vaginal discharge. The answer for each item is "yes" or "no".
4 secondary outcomes
Progesterone administration route that the patients prefer
Time frame: At the human chorionic gonadotropin test performed after 14 days of progesterone use
Implantation rate
Time frame: At the human chorionic gonadotropin test performed after 14 days of progesterone use
Clinically pregnancy rate
Time frame: At 6 week from oocyte retrieval
live birth rate
Time frame: At nine months from 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 18 May 2022.
- 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.
Simone Garzon, M.D. principal investigator
Universita di Verona
Rossana Di Paola, M.D. principal investigator
Universita di Verona
Antonio Simone Laganà principal investigator
Università degli Studi dell'Insubria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Subcutaneous Progesterone and Vaginal progesterone in people with Progesterone and Luteal Phase Support, run by Universita di Verona 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 1 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 18 May 2022. 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?
Grade of use satisfaction reported by the patients (time frame: At the human chorionic gonadotropin test performed after 14 days of progesterone use). The study lists 3 primary outcomes in all. 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 18 May 2022.