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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-000290-12 | EudraCT Number |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prolutex | Experimental | Subcutaneous progesterone |
|
| Prontogest | Active Comparator | Intramuscular progesterone |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Subcutaneous progesterone | Drug | subcutaneous progesterone 25 mg/day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Predecidual Transformation | Histologic dating of the endometrium at day 5: early secretory phase, media secretory phase or late secretory phase | 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%) | 5 days |
| Endometrial Maturation Using Noyes' Criteria | Endometrial dating of luteal phase days according to the Noyes criteria | 5 days |
| Endometrial Gene Expression | Gene expression profile of endometrial | 5 days |
| Endometrial Gene Expression Difference | Genes with a significantly high gene expression difference (adj-p-value < 0.05, Fold Change>3) | 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Endometrial Thickness | Endometrial thickness measurement by means of transvaginal ultrasound. | 5 days |
| Blood Estradiol Level | Blood estradiol level on the day of follicular puncture |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AgustÃn B Boluda | IVI Barcelona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IVI Barcelona | Barcelona | 08017 | Spain |
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| ID | Title | Description |
|---|---|---|
| FG000 | Prolutex | Subcutaneous progesterone Subcutaneous progesterone: subcutaneous progesterone 25 mg/day |
| FG001 | Prontogest | Intramuscular progesterone Intramuscular progesterone: intramuscular progesterone 50 mg/day |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Prolutex | Subcutaneous progesterone Subcutaneous progesterone: subcutaneous progesterone 25 mg/day |
| BG001 | Prontogest | Intramuscular progesterone Intramuscular progesterone: intramuscular progesterone 50 mg/day |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Predecidual Transformation | Histologic dating of the endometrium at day 5: early secretory phase, media secretory phase or late secretory phase | Posted | Number | participants | 5 days |
|
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5 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Prolutex | Subcutaneous progesterone Subcutaneous progesterone: subcutaneous progesterone 25 mg/day |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain in injection site | General disorders | Non-systematic Assessment | Pain in injection site |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Evelin Lara Molina | IVI Barcelona | +34 93 531 63 00 | 27503 | Evelin.Lara@ivi.es |
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| ID | Term |
|---|---|
| D006379 | Helping Behavior |
| ID | Term |
|---|---|
| D012919 | Social Behavior |
| D001519 | Behavior |
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Parallel Assignment
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Masked samples for histological evaluation and assessment of gene expression
| Intramuscular progesterone | Drug | intramuscular progesterone 50 mg/day |
|
|
| day 0 |
| Blood Progesterone Level | Blood progesterone level on the day of follicular puncture | day 0 |
| Blood LH Level | Blood Luteinizing hormone level on the day of follicular puncture | day 0 |
| Blood Estradiol Level | Blood estradiol level 5 days after progesterone treatment | 5 days |
| Blood Progesterone Level | Blood progesterone level 5 days after progesterone treatment | 5 days |
| Blood LH Level | Blood Luteinizing hormone level 5 days after progesterone treatment | 5 days |
| Number of Participants With Side Effects During the Study | Number of Participants with side effects during the study" | 5 days |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
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| Height | Mean | Standard Deviation | cm |
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| Weight | Mean | Standard Deviation | Kg |
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| Blood Progesterone Level | Blood progesterone level in Day -2 | Mean | Standard Deviation | ng/ml |
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| Blood Estradiol Level | Blood Estradiol Level in day -2 | Mean | Standard Deviation | pg/ml |
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| Blood LH level | Blood LH level in day -2 | Mean | Standard Deviation | pg/ml |
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| Endometrial Thickness | Endometrial Thickness in day 0 | Mean | Standard Deviation | mm |
|
| Participants |
|
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| Primary | 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%) | Posted | Number | participants | 5 days |
|
|
|
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| Primary | Endometrial Maturation Using Noyes' Criteria | Endometrial dating of luteal phase days according to the Noyes criteria | Posted | Mean | Standard Deviation | days | 5 days |
|
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|
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| Primary | Endometrial Gene Expression | Gene expression profile of endometrial | We assessed the gene expression of 238 endometrial genes to detect differences in gene expression between treatments. This analysis could not be performed in 1 patient of the prolutex group because of the poor quality of the sample collected | Posted | Number | Endometrial genes | 5 days | Endometrial genes | Endometrial genes |
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| Secondary | Endometrial Thickness | Endometrial thickness measurement by means of transvaginal ultrasound. | Posted | Mean | Standard Deviation | mm | 5 days |
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| Secondary | Blood Estradiol Level | Blood estradiol level on the day of follicular puncture | Posted | Mean | Standard Deviation | pg/mL | day 0 |
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| Secondary | Blood Progesterone Level | Blood progesterone level on the day of follicular puncture | Posted | Mean | Standard Deviation | ng/mL | day 0 |
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|
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| Secondary | Blood LH Level | Blood Luteinizing hormone level on the day of follicular puncture | Posted | Mean | Standard Deviation | pg/mL | day 0 |
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| Secondary | Blood Estradiol Level | Blood estradiol level 5 days after progesterone treatment | Posted | Mean | Standard Deviation | pg/mL | 5 days |
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| Secondary | Blood Progesterone Level | Blood progesterone level 5 days after progesterone treatment | Posted | Mean | Standard Deviation | ng/mL | 5 days |
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| Secondary | Blood LH Level | Blood Luteinizing hormone level 5 days after progesterone treatment | Posted | Mean | Standard Deviation | pg/mL | 5 days |
|
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| Secondary | Number of Participants With Side Effects During the Study | Number of Participants with side effects during the study" | Posted | Number | participants | 5 days |
|
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| Primary | Endometrial Gene Expression Difference | Genes with a significantly high gene expression difference (adj-p-value < 0.05, Fold Change>3) | We assessed the expressed genes with a significantly high gene expression difference between treatments (adj-p-value < 0.05, Fold Change>3) This analysis could not be performed in 1 patient of the prolutex group because of the poor quality of the sample collected | Posted | Number | Endometrial genes | 5 days | Endometrial genes | Endometrial genes |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 5 |
| 12 |
| EG001 | Prontogest | Intramuscular progesterone Intramuscular progesterone: intramuscular progesterone 50 mg/day | 0 | 12 | 0 | 12 | 4 | 12 |
|
| Discomfort in injection site | General disorders | Non-systematic Assessment | Discomfort in injection site |
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| Breast inflammation | Reproductive system and breast disorders | Non-systematic Assessment | Breast inflammation |
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| > 50% of stromal cell |
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