Reproductive Techniques, AssistedPhase 4NCT02567552
Clinical Trial Comparing Endometrial Transformation With Subcutaneous Progesterone Versus Intramuscular Progesterone
A Phase 4 study testing Subcutaneous progesterone and Intramuscular progesterone in people with Reproductive Techniques, Assisted, run by IVI Barcelona at 1 site in Spain.
Trial summary
Study the endometrial predecidualization by using subcutaneous progesterone 25 mg/day versus intramuscular progesterone 50 mg/day, to determine whether there are differences in the endometrial transformation and endometrial receptivity. Read more about this study
- Who is it for?
- Ages 18 to 34 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Reproductive Techniques, Assisted
- What is being tested?
- Subcutaneous progesterone and Intramuscular progesterone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSpain
- Study dates
- May 2015to Jan 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 34 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female aged between 18 and 34 years
- BMI between 18 and 28 kg/m2
- Endometrial thickness > 7 mm the day of progesterone treatment initiation (day of follicular puncture)
- Follicular maturation with a single bolus of GnRH agonist
- Egg donors who undergo a cycle of ovarian stimulation in the IVI Barcelona Centre
- Egg donors selected in accordance with the requirements of Law 14/2006 of 26 May 2006 on Assisted Human Reproduction Techniques
- Informed consent has been signed and dated
Who cannot join
- Known allergy to progesterone formulations or their excipients
- Known allergy to estrogens
- Known thrombophilias
- Alcohol, drug or psychotropic medication dependence
- Concurrent participation in another study
- Concomitant medication that may interfere with the study medication and ovarian stimulation
- Failure to comply with the requirements for egg donors in accordance with Law 14/2006 of 26 May 2006 on Assisted Human Reproduction Techniques
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Clinical Trial Comparing Endometrial Transformation With Subcutaneous Progesterone (Prolutex) 25 mg/Day Versus Intramuscular Progesterone (Prontogest) 50 mg/Day
Study the endometrial predecidualization by using subcutaneous progesterone 25 mg/day versus intramuscular progesterone 50 mg/day, to determine whether there are differences in the endometrial transformation and endometrial receptivity.
Read the detailed description
The aim of this study is to compare predecidualization and endometrial receptivity as gene expression by using subcutaneous progesterone 25 mg/day versus intramuscular progesterone 50 mg/day in healthy women of childbearing age. Both, the two drugs and the doses administered in this clinical trial, are routine clinical practice.
A controlled ovarian stimulation will be previously performed and following routine clinical practice for 10-12 days at standard doses of subcutaneous FSH 150-225 IU/day, according to BMI and number of antral follicles. A GnRH antagonist shall be administered, being initiated according to donor's follicular growth from greater or equal14 mm diameter follicles. Final maturation shall be performed with a bolus of GnRH agonist when there exist at least 3 follicles greater or equal17 mm diameter, and therefore performing follicular puncture 36 hours after the bolus of agonist has been administered.
If the donor meets the inclusion criteria, she will be informed of the study and, if she agrees, she will sign the informed consent. Randomization shall be performed in 2 arms; arm 1 will be administered subcutaneous progesterone 25 mg/day (Prolutex; Angelini, Spain), and arm 2, intramuscular progesterone 50 mg/day (Prontogest IBSA, Italy). In each arm 12 donors (ITT population) will be included.
The randomization to a treatment group shall be performed the day the follicular puncture has been programmed. To that purpose, a randomized consecutive sampling will be used by means of assignment tables. The medication will be administered by a person not involved in the assessments and responsible for group assignment, data centralization and drug assignment.
At day 5 (5 days after follicular puncture):endometrial thickness measurement by means of transvaginal ultrasound and perform endometrial biopsy and take two samples: 1 sample to Anatomical Pathology and 1 sample to Endometrial Receptivity Array (ERA).
- Conditions
- Reproductive Techniques, Assisted
- Being tested
- Subcutaneous progesterone, Intramuscular progesterone
- Keywords
- endometrial receptivity, endometrial predecidualization, endometrial genomics, endometrial receptivity array
- Medical subject headings
- Helping Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subcutaneous progesteroneDrug
Also called Prolutex
subcutaneous progesterone 25 mg/day
Intramuscular progesteroneDrug
Also called Prontogest
intramuscular progesterone 50 mg/day
| Study group | Role | What they receive |
|---|---|---|
| Prolutex | Experimental | Subcutaneous progesterone Receives: Drug: Subcutaneous progesterone |
| Prontogest | Active comparator | Intramuscular progesterone Receives: Drug: Intramuscular progesterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predecidual Transformation
Histologic dating of the endometrium at day 5: early secretory phase, media secretory phase or late secretory phase
Measured: 5 days
Decidualization of Stromal Cell
Rate of transformation of endometrial stromal fibroblasts into specialized secretory decidual cells (three categories: less than 25%, between 26% and 50%, and over 50%)
Measured: 5 days
Endometrial Maturation Using Noyes' Criteria
Endometrial dating of luteal phase days according to the Noyes criteria
Measured: 5 days
Endometrial Gene Expression
Gene expression profile of endometrial
Measured: 5 days
Endometrial Gene Expression Difference
Genes with a significantly high gene expression difference (adj-p-value < 0.05, Fold Change>3)
Measured: 5 days
Secondary outcomes (8)
Endometrial Thickness
Endometrial thickness measurement by means of transvaginal ultrasound.
Measured: 5 days
Blood Estradiol Level
Blood estradiol level on the day of follicular puncture
Measured: day 0
Blood Progesterone Level
Blood progesterone level on the day of follicular puncture
Measured: day 0
Blood LH Level
Blood Luteinizing hormone level on the day of follicular puncture
Measured: day 0
Blood Estradiol Level
Blood estradiol level 5 days after progesterone treatment
Measured: 5 days
Blood Progesterone Level
Blood progesterone level 5 days after progesterone treatment
Measured: 5 days
Blood LH Level
Blood Luteinizing hormone level 5 days after progesterone treatment
Measured: 5 days
Number of Participants With Side Effects During the Study
Number of Participants with side effects during the study"
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2015 (estimated)
- Study startMay 2015
- Primary completionDec 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Reproductive Techniques, AssistedStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- IVI Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Agustín B Boluda, Principal investigator, IVI Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02567552
- Sponsor's protocol ID
- 1412-BCN-087-AB
- Other IDs
- 2015-000290-12, 2015
- Status last verified
- Feb 2019
- First submitted
- 2 Oct 2015
- Last updated
- 16 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial Comparing Endometrial Transformation With Subcutaneous Progesterone (Prolutex) 25 mg/Day Versus Intramuscular Progesterone (Prontogest) 50 mg/Day
- ClinicalTrials.gov ID
- NCT02567552
- Acronym / sponsor ID
- 1412-BCN-087-AB
- Conditions
- Reproductive Techniques, Assisted
- Keywords
- endometrial receptivity, endometrial predecidualization, endometrial genomics, endometrial receptivity array
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- IVI BarcelonaUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 5 Oct 2015 (estimated)
- Results
- Posted 19 Mar 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study the endometrial predecidualization by using subcutaneous progesterone 25 mg/day versus intramuscular progesterone 50 mg/day, to determine whether there are differences in the endometrial transformation and endometrial receptivity.
Detailed description
The aim of this study is to compare predecidualization and endometrial receptivity as gene expression by using subcutaneous progesterone 25 mg/day versus intramuscular progesterone 50 mg/day in healthy women of childbearing age. Both, the two drugs and the doses administered in this clinical trial, are routine clinical practice.
A controlled ovarian stimulation will be previously performed and following routine clinical practice for 10-12 days at standard doses of subcutaneous FSH 150-225 IU/day, according to BMI and number of antral follicles. A GnRH antagonist shall be administered, being initiated according to donor's follicular growth from greater or equal14 mm diameter follicles. Final maturation shall be performed with a bolus of GnRH agonist when there exist at least 3 follicles greater or equal17 mm diameter, and therefore performing follicular puncture 36 hours after the bolus of agonist has been administered.
If the donor meets the inclusion criteria, she will be informed of the study and, if she agrees, she will sign the informed consent. Randomization shall be performed in 2 arms; arm 1 will be administered subcutaneous progesterone 25 mg/day (Prolutex; Angelini, Spain), and arm 2, intramuscular progesterone 50 mg/day (Prontogest IBSA, Italy). In each arm 12 donors (ITT population) will be included.
The randomization to a treatment group shall be performed the day the follicular puncture has been programmed. To that purpose, a randomized consecutive sampling will be used by means of assignment tables. The medication will be administered by a person not involved in the assessments and responsible for group assignment, data centralization and drug assignment.
At day 5 (5 days after follicular puncture):endometrial thickness measurement by means of transvaginal ultrasound and perform endometrial biopsy and take two samples: 1 sample to Anatomical Pathology and 1 sample to Endometrial Receptivity Array (ERA).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Prolutex | Experimental | Drug: Subcutaneous progesteroneSubcutaneous progesterone |
| Prontogest | Active comparator | Drug: Intramuscular progesteroneIntramuscular progesterone |
Who may qualify
- Ages
- 18 to 34 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Female aged between 18 and 34 years
- BMI between 18 and 28 kg/m2
- Endometrial thickness > 7 mm the day of progesterone treatment initiation (day of follicular puncture)
- Follicular maturation with a single bolus of GnRH agonist
- Egg donors who undergo a cycle of ovarian stimulation in the IVI Barcelona Centre
Key exclusion criteria (7 listed)
- Known allergy to progesterone formulations or their excipients
- Known allergy to estrogens
- Known thrombophilias
- Alcohol, drug or psychotropic medication dependence
- Concurrent participation in another study
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 progesteroneAlso: Prolutexsubcutaneous progesterone 25 mg/day | Drug | Prolutex |
| Intramuscular progesteroneAlso: Prontogestintramuscular progesterone 50 mg/day | Drug | Prontogest |
Primary outcome
Predecidual Transformation
Time frame: 5 days
Histologic dating of the endometrium at day 5: early secretory phase, media secretory phase or late secretory phase
Decidualization of Stromal Cell
Time frame: 5 days
Rate of transformation of endometrial stromal fibroblasts into specialized secretory decidual cells (three categories: less than 25%, between 26% and 50%, and over 50%)
Endometrial Maturation Using Noyes' Criteria
Time frame: 5 days
Endometrial dating of luteal phase days according to the Noyes criteria
Endometrial Gene Expression
Time frame: 5 days
Gene expression profile of endometrial
Endometrial Gene Expression Difference
Time frame: 5 days
Genes with a significantly high gene expression difference (adj-p-value < 0.05, Fold Change>3)
8 secondary outcomes
Endometrial Thickness
Time frame: 5 days
Blood Estradiol Level
Time frame: day 0
Blood Progesterone Level
Time frame: day 0
Blood LH Level
Time frame: day 0
Blood Estradiol Level
Time frame: 5 days
Blood Progesterone Level
Time frame: 5 days
Blood LH Level
Time frame: 5 days
Number of Participants With Side Effects During the Study
Time frame: 5 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Reproductive Techniques, Assisted
Enrolling by invitation
A Web-Based Tool to Help People With Health Conditions Make Contraceptive Decisions
Contraceptive Usage, Contraceptive Behavior
Enrolling by invitation
Multifaceted Benefits of Auricular Point Sticking for IVF Patients: Psychological Well-being, Sleep, and Treatment Outcomes
Infertility, Female, Anxiety
Recruiting
The Feasibility of taVNS on Pregnancy Outcomes of Infertility Patients Undergoing IVF
Infertility Assisted Reproductive Technology
RecruitingObservational study
Food Intake Among Women and Men in Fertility Treatment
Infertility
RecruitingObservational study
Discarded Materials Study
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.
Agustín B Boluda principal investigator
IVI Barcelona
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 Subcutaneous progesterone and Intramuscular progesterone in people with Reproductive Techniques, Assisted, run by IVI Barcelona at 1 site in Spain.
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 7 inclusion and 7 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 Dec 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 Spain. 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?
Yes. Results are posted in the registry (first posted 19 Mar 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Predecidual Transformation (time frame: 5 days). The study lists 5 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 16 Dec 2019.