InfertilityPhase 4NCT03181685
Patients' Preference for Subcutaneous or Vaginal Progesterone as Luteal Support in IVF/ICSI Cycles
A Phase 4 study testing Progesterone 25 MG subcutaneous, Micronized progesterone 200 MG and recombinant FSH in people with Infertility and In Vitro Fertilization, run by Andros Day Surgery Clinic at 1 site in Italy.
Trial summary
This randomized, controlled, prospective, crossover, open-label, two-treatments, two-period trial aimed to evaluate the preference expressed by the patient concerning the subcutaneous administration of progesterone versus the vaginal one. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women only
- Conditions the study is for
- Infertility, In Vitro Fertilization
- What is being tested?
- Progesterone 25 MG subcutaneous, Micronized progesterone 200 MG and recombinant FSH
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 20 Dec 2016to Dec 2019
- 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 44 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- first IVF/ICSI attempt (at the enrolment), regular menstrual cycles (25-33 days), controlled ovarian stimulation performed with Gonadotropin Releasing Hormone (GnRH) antagonists and gonadotrophins (recombinant FSH)
Who cannot join
- systemic diseases, chronic medical therapies, pregnancy in one of the IVF/ICSI cycles, embryo "freeze all" strategy in one of the IVF/ICSI cycles for preventing Ovarian Hyperstimulation Syndrome (OHSS)
Trial locations and contacts
1 site in 1 country.
Italy1 site
ANDROS Day Surgery Clinic, Reproductive Medicine Unit
Palermo, 90144
About this study
Official title: Subcutaneous Versus Vaginal Progesterone as Luteal Support in IVF/ICSI Cycles: Which is the Preference Expressed by the Patients?
This randomized, controlled, prospective, crossover, open-label, two-treatments, two-period trial aimed to evaluate the preference expressed by the patient concerning the subcutaneous administration of progesterone versus the vaginal one.
The couples, scheduled for performing 2 In Vitro Fertilization (IVF)/Intracytoplasmic Sperm Injection (ICSI) cycles will be randomized to receive, as luteal phase supplementation, Pleyris 25 milligram (mg) (a single subcutaneous administration per day) or Prometrium 200 mg (3 vaginal administrations per day).
Read the detailed description
Each participant will receive both treatments. During the first IVF/ICSI cycle, the luteal phase will be supplemented with subcutaneous progesterone (S) or vaginal progesterone (V). At the end of the cycle (on the day of beta-hCG), a survey for determining the level of satisfaction will be administered and filled in by the patient during the waiting time and always before the knowledge of the result. This practical organization allows the elimination of emotional biases correlated with the outcome. In case of a negative beta-hCG, the patient will be scheduled for a second IVF/ICSI cycle after a washout (W) period (between 2 and 6 months). In the second cycle, the patient will undergo, during the luteal phase, the opposite treatment (V or S). Also in this case, the survey for evaluating the level of satisfaction will be administered on the day of beta-hCG, with the same modalities of the first cycle. The domains of the surveys are focused on facility of the administration, comfort, level of complaint, side effects, overall level of satisfaction.
The sequence S-V or V-S will be randomly assigned (random assignment) with the concealment of the allocation.
In case of a negative beta-hCG also in the second cycle, a post-hoc comparison between the two treatments will be carried out through a Semantic Differential Scale, in the "follow-up" phase.
- Conditions
- Infertility, In Vitro Fertilization
- Being tested
- Progesterone 25 MG subcutaneous, Micronized progesterone 200 MG, recombinant FSH, Cetrorelix Acetate
- Keywords
- Progesterone supplementation, IVF, Preference expressed by the patient
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progesterone 25 MG subcutaneousDrug
Also called Pleyris
A single subcutaneous administration per day from the day of oocyte retrieval
Micronized progesterone 200 MGDrug
Also called Prometrium
3 vaginal administrations per day from the day of oocyte retrieval
recombinant FSHDrug
Also called Gonal-f
Controlled ovarian stimulation (COS)
Cetrorelix AcetateDrug
Also called Cetrotide
Inhibition of Luteinizing Hormone (LH) premature surge during COS
| Study group | Role | What they receive |
|---|---|---|
| Treatment S (Subcutaneous) | Active comparator | Progesterone 25 mg subcutaneous (a single administration per day) from the day of oocyte retrieval. Controlled ovarian stimulation (COS) will be performed with recombinant FSH and cetrorelix acetate. Receives: Drug: Progesterone 25 MG subcutaneous; Drug: recombinant FSH; Drug: Cetrorelix Acetate |
| Treatment V (Vaginal) | Active comparator | Micronized progesterone 200 mg (3 vaginal administrations per day) from the day of oocyte retrieval. Controlled ovarian stimulation (COS) will be performed with recombinant FSH and cetrorelix acetate. Receives: Drug: Micronized progesterone 200 MG; Drug: recombinant FSH; Drug: Cetrorelix Acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surveys for testing the satisfaction
Patient's level of satisfaction will be measured as score on 5-point likert scale + 2 qualitative response
Measured: Single administration at the end of each treatment cycle (an average of 28 days)
Secondary outcomes (1)
Semantic Differential Scale
Patient's preference of treatment measured on a 7-point likert scale
Measured: Single administration at the end of two treatment cycles (an average of 130 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2017
- Study start20 Dec 2016
- Primary completionDec 2019
- Study completionDec 2019
Why it stopped: 27 couples were recruited. This unexpected poor recruitment was due to more clinical pregnancies (for a better patients' selection) and more freeze-all cycles.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is randomized, controlled, prospective, crossover, open-label, two-treatments, two-period trial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andros Day Surgery Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adolfo Allegra, MD, Principal investigator, Andros Day Surgery Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03181685
- Sponsor's protocol ID
- Andros Day Surgery Clinic
- Status last verified
- Jan 2020
- First submitted
- 31 May 2017
- Last updated
- 10 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Beltsos AN, Sanchez MD, Doody KJ, Bush MR, Domar AD, Collins MG. Patients' administration preferences: progesterone vaginal insert (Endometrin(R)) compared to intramuscular progesterone for Luteal phase support. Reprod Health. 2014 Nov 11;11:78. doi: 10.1186/1742-4755-11-78.
PubMed 25385669van der Linden M, Buckingham K, Farquhar C, Kremer JA, Metwally M. Luteal phase support for assisted reproduction cycles. Cochrane Database Syst Rev. 2015 Jul 7;2015(7):CD009154. doi: 10.1002/14651858.CD009154.pub3.
PubMed 26148507Yanushpolsky E, Hurwitz S, Greenberg L, Racowsky C, Hornstein M. Crinone vaginal gel is equally effective and better tolerated than intramuscular progesterone for luteal phase support in in vitro fertilization-embryo transfer cycles: a prospective randomized study. Fertil Steril. 2010 Dec;94(7):2596-9. doi: 10.1016/j.fertnstert.2010.02.033. Epub 2010 Mar 27.
PubMed 20347079
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subcutaneous Versus Vaginal Progesterone as Luteal Support in IVF/ICSI Cycles: Which is the Preference Expressed by the Patients?
- ClinicalTrials.gov ID
- NCT03181685
- Acronym / sponsor ID
- Andros Day Surgery Clinic
- Conditions
- Infertility, In Vitro Fertilization
- Keywords
- Progesterone supplementation, IVF, Preference expressed by the patient
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: 27 couples were recruited. This unexpected poor recruitment was due to more clinical pregnancies (for a better patients' selection) and more freeze-all cycles.
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Andros Day Surgery ClinicUniversity, hospital or other
- Study start
- 20 Dec 2016 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 9 Jun 2017 (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.
This randomized, controlled, prospective, crossover, open-label, two-treatments, two-period trial aimed to evaluate the preference expressed by the patient concerning the subcutaneous administration of progesterone versus the vaginal one.
The couples, scheduled for performing 2 In Vitro Fertilization (IVF)/Intracytoplasmic Sperm Injection (ICSI) cycles will be randomized to receive, as luteal phase supplementation, Pleyris 25 milligram (mg) (a single subcutaneous administration per day) or Prometrium 200 mg (3 vaginal administrations per day).
Detailed description
Each participant will receive both treatments. During the first IVF/ICSI cycle, the luteal phase will be supplemented with subcutaneous progesterone (S) or vaginal progesterone (V). At the end of the cycle (on the day of beta-hCG), a survey for determining the level of satisfaction will be administered and filled in by the patient during the waiting time and always before the knowledge of the result. This practical organization allows the elimination of emotional biases correlated with the outcome. In case of a negative beta-hCG, the patient will be scheduled for a second IVF/ICSI cycle after a washout (W) period (between 2 and 6 months). In the second cycle, the patient will undergo, during the luteal phase, the opposite treatment (V or S). Also in this case, the survey for evaluating the level of satisfaction will be administered on the day of beta-hCG, with the same modalities of the first cycle. The domains of the surveys are focused on facility of the administration, comfort, level of complaint, side effects, overall level of satisfaction.
The sequence S-V or V-S will be randomly assigned (random assignment) with the concealment of the allocation.
In case of a negative beta-hCG also in the second cycle, a post-hoc comparison between the two treatments will be carried out through a Semantic Differential Scale, in the "follow-up" phase.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- This is randomized, controlled, prospective, crossover, open-label, two-treatments, two-period trial
| Arm | Type | Receives |
|---|---|---|
| Treatment S (Subcutaneous) | Active comparator | Drug: Progesterone 25 MG subcutaneous, Drug: recombinant FSH, Drug: Cetrorelix AcetateProgesterone 25 mg subcutaneous (a single administration per day) from the day of oocyte retrieval. Controlled ovarian stimulation (COS) will be performed with recombinant FSH and cetrorelix acetate. |
| Treatment V (Vaginal) | Active comparator | Drug: Micronized progesterone 200 MG, Drug: recombinant FSH, Drug: Cetrorelix AcetateMicronized progesterone 200 mg (3 vaginal administrations per day) from the day of oocyte retrieval. Controlled ovarian stimulation (COS) will be performed with recombinant FSH and cetrorelix acetate. |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- first IVF/ICSI attempt (at the enrolment), regular menstrual cycles (25-33 days), controlled ovarian stimulation performed with Gonadotropin Releasing Hormone (GnRH) antagonists and gonadotrophins (recombinant FSH)
Key exclusion criteria (1 listed)
- systemic diseases, chronic medical therapies, pregnancy in one of the IVF/ICSI cycles, embryo "freeze all" strategy in one of the IVF/ICSI cycles for preventing Ovarian Hyperstimulation Syndrome (OHSS)
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 |
|---|---|---|
| Progesterone 25 MG subcutaneousAlso: PleyrisA single subcutaneous administration per day from the day of oocyte retrieval | Drug | Treatment S (Subcutaneous) |
| Micronized progesterone 200 MGAlso: Prometrium3 vaginal administrations per day from the day of oocyte retrieval | Drug | Treatment V (Vaginal) |
| recombinant FSHAlso: Gonal-fControlled ovarian stimulation (COS) | Drug | Treatment S (Subcutaneous), Treatment V (Vaginal) |
| Cetrorelix AcetateAlso: CetrotideInhibition of Luteinizing Hormone (LH) premature surge during COS | Drug | Treatment S (Subcutaneous), Treatment V (Vaginal) |
Primary outcome
Surveys for testing the satisfaction
Time frame: Single administration at the end of each treatment cycle (an average of 28 days)
Patient's level of satisfaction will be measured as score on 5-point likert scale + 2 qualitative response
1 secondary outcome
Semantic Differential Scale
Time frame: Single administration at the end of two treatment cycles (an average of 130 days)
Results and safety
The study was stopped early (reason given: 27 couples were recruited. This unexpected poor recruitment was due to more clinical pregnancies (for a better patients' selection) and more freeze-all cycles.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2020.
- Background: PubMed 25385669Beltsos AN, Sanchez MD, Doody KJ, Bush MR, Domar AD, Collins MG. Patients' administration preferences: progesterone vaginal insert (Endometrin(R)) compared to intramuscular progesterone for Luteal phase support. Reprod Health. 2014 Nov 11;11:78. doi: 10.1186/1742-4755-11-78.
- Background: PubMed 26148507van der Linden M, Buckingham K, Farquhar C, Kremer JA, Metwally M. Luteal phase support for assisted reproduction cycles. Cochrane Database Syst Rev. 2015 Jul 7;2015(7):CD009154. doi: 10.1002/14651858.CD009154.pub3.
- Background: PubMed 20347079Yanushpolsky E, Hurwitz S, Greenberg L, Racowsky C, Hornstein M. Crinone vaginal gel is equally effective and better tolerated than intramuscular progesterone for luteal phase support in in vitro fertilization-embryo transfer cycles: a prospective randomized study. Fertil Steril. 2010 Dec;94(7):2596-9. doi: 10.1016/j.fertnstert.2010.02.033. Epub 2010 Mar 27.
- Individual participant dataSharing planned: No
Related trials for Infertility
RecruitingPhase 3
A Study to Compare the Efficacy and Safety of Follitropin Alfa/Lutropin Alfa Versus hMG in Japanese Participants With LH and FSH Deficiency Undergoing ART (HINATA)
Infertility
Active, not recruitingObservational study
Fresh Versus Vitrified-Warmed Donor Oocytes: Embryological and Clinical Outcomes
Infertility, Donor Oocyte Assisted Reproduction
RecruitingObservational study
Safety and Efficacy of Corifollitropin Alfa N02 Injection in Elderly Women Undergoing Assisted Reproductive Technology (ART)
Infertility
Active, not recruiting
Automation of the In Vitro Fertilization Laboratory
Infertility, ART
Not yet recruiting
Implementing IVM for Fertility Treatment in Clinical Practice
Infertility
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.
Adolfo Allegra, MD principal investigator
Andros Day Surgery Clinic
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 Progesterone 25 MG subcutaneous, Micronized progesterone 200 MG and recombinant FSH in people with Infertility and In Vitro Fertilization, run by Andros Day Surgery Clinic 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 1 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: stopped early, as of the sponsor's last update on 10 Jan 2020. 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 was stopped early (reason given: 27 couples were recruited. This unexpected poor recruitment was due to more clinical pregnancies (for a better patients' selection) and more freeze-all cycles.). Results are not available in the source record.
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?
Surveys for testing the satisfaction (time frame: Single administration at the end of each treatment cycle (an average of 28 days)). 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 NCT03181685, which also lists 3 linked publications.
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 10 Jan 2020.