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After so many years conducting artificial endometrial preparation cycles for embryo transfer, there is no clear indication about which is the optimal dose of exogenous progesterone in this scenario to optimize the outcome. Taking into account that the luteal phase can be controlled by measuring serum P levels (not done until now), the next step is to find out which is the best dose and route of administration of exogenous progesterone for luteal phase in artificial cycles.
Therefore, the aim of this experimental study is to compare the endometrial function and structure, as well as the serum P levels according to the use of different types of exogenous progesterone available on the market depending on their doses and route of administration (vaginal, subcutaneous or intramuscular). The endometrial receptivity status will be compared in the different artificial cycles with the one observed in a natural cycle, without exogenous progesterone (only the endogenous one) as a control group.
Endometrial receptivity will be analysed by means of endometrial function and structure, but not by pregnancy outcome as in this study an embryo cannot be replaced in the uterus because an endometrial biopsy needs to be done to do this type of research.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| I: Artificial endometrial preparation cycle | Experimental | Artificial endometrial preparation cycle with estrogens and vaginal natural micronized progesterone 400mg/12h |
|
| II: Artificial endometrial preparation cycle | Experimental | Artificial endometrial preparation cycle with estrogens and subcutaneous natural progesterone 25mg/24h |
|
| III: Artificial endometrial preparation cycle | Experimental | Artificial endometrial preparation cycle with estrogens and subcutaneous natural progesterone 25mg/12h |
|
| IV: Artificial endometrial preparation cycle | Experimental | Artificial endometrial preparation cycle with estrogens and a combination of subcutaneous natural progesterone 25mg/24h + vaginal natural micronized progesterone 400mg/24h |
|
| V: Artificial endometrial preparation cycle | Experimental | Artificial endometrial preparation cycle with estrogens and intramuscular natural progesterone 50mg/24h |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Progesterone | Drug | Subjects will undergo an artificial cycle with hormone replacement therapy (HRT) with the aim of comparing the endometrial gene expression profile in the different types of exogenous progesterone with different doses and routes of administration. |
| Measure | Description | Time Frame |
|---|---|---|
| Endometrial gene expression profile | Determination of gene expression | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Histological dating of endometrial biopsies | Endometrial classification using Noyes criteria | 12 months |
| Progesterone concentration in the endometrium | Endometrial progesterone values |
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Inclusion Criteria
All women with no history of infertility who agree to participate in the study:
Exclusion Criteria
Subjects who meet one or more of the following will not be considered eligible to participate in the pilot study:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Valenciano de Infertilidad Spain | Valencia | Valencia | 46015 | Spain |
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Exploratory, unicentric, with blind evaluators, randomized to six parallel arms in ratio 1:1:1:1:1:1 clinical trial conducted in healthy volunteers under an artificial endometrial preparation cycle and luteal phase support with exogenous progesterone administered by different doses and routes or natural menstrual cycles.
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Patients will be evaluated by blinded gynecologist in order to prevent the application of personal criteria and protect the consistence of the study.
| Natural menstrual cycle | Active Comparator | Natural menstrual cycle (without any exogenous steroid hormone Treatment) |
|
| Artificial Cycle (no intervention) | Other | Control group of 19 subjects in the context of a natural cycle with only endogenous progesterone present |
|
| 12 months |
| Serum Progesterone concentrations | Blood serum progesterone values | 12 months |
| Correlation between progesterone levels in blood and uterus. | Presence or Absence of correlation | 12 months |
| Correlation between serum and uterine levels with endometrial transcriptome and histological dating | Presence or Absence of correlation | 12 months |
| ID | Term |
|---|---|
| D007247 | Infertility, Female |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D007246 | Infertility |
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| ID | Term |
|---|---|
| D011374 | Progesterone |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D003339 | Corpus Luteum Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045167 | Progesterone Congeners |
| D012739 | Gonadal Steroid Hormones |
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