PROGENDO: Impact of Different Doses and Routes of Exogenous Progesterone Administration on Endometrial Receptivity Parameters
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: I: Artificial endometrial preparation cycle Artificial endometrial preparation cycle with estrogens and vaginal natural micronized progesterone 400mg/12h |
Drug: Progesterone
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.
|
Experimental: II: Artificial endometrial preparation cycle Artificial endometrial preparation cycle with estrogens and subcutaneous natural progesterone 25mg/24h |
Drug: Progesterone
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.
|
Experimental: III: Artificial endometrial preparation cycle Artificial endometrial preparation cycle with estrogens and subcutaneous natural progesterone 25mg/12h |
Drug: Progesterone
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.
|
Experimental: IV: Artificial endometrial preparation cycle Artificial endometrial preparation cycle with estrogens and a combination of subcutaneous natural progesterone 25mg/24h + vaginal natural micronized progesterone 400mg/24h |
Drug: Progesterone
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.
|
Experimental: V: Artificial endometrial preparation cycle Artificial endometrial preparation cycle with estrogens and intramuscular natural progesterone 50mg/24h |
Drug: Progesterone
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.
|
Active Comparator: Natural menstrual cycle Natural menstrual cycle (without any exogenous steroid hormone Treatment) |
Other: Artificial Cycle (no intervention)
Control group of 15 subjects in the context of a natural cycle with only endogenous progesterone present
|
Outcome Measures
Primary Outcome Measures
- Endometrial gene expression profile [12 months]
Determination of gene expression
Secondary Outcome Measures
- Histological dating of endometrial biopsies [12 months]
Endometrial classification using Noyes criteria
- Histological analysis of the endometrial tissue using electron microscopy [12 months]
Presence or Absence of Pinopodes
- Progesterone concentration in the endometrium [12 months]
Endometrial progesterone values
- Serum Progesterone concentrations [12 months]
Blood serum progesterone values
- Correlation between progesterone levels in blood and uterus. [12 months]
Presence or Absence of correlation
- Correlation between serum and uterine levels with endometrial transcriptome and histological dating [12 months]
Presence or Absence of correlation
Eligibility Criteria
Criteria
Inclusion Criteria
All women with no history of infertility who agree to participate in the study:
-
Age: 18-35 years old, both inclusive
-
Regular menstrual cycles
-
In good health and not suffering from any mental or medical condition(s) that would preclude participation 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:
-
Simultaneous participation in other clinical studies that, at the researcher's criteria, could interfere with the results of this study.
-
Taking oral contraceptives in the three months prior to signing informed consent.
-
Presence of uterine pathology (submucosal or intramural myomas >4 cm deforming cavity, endometrial polyps or müllerian anomalies) or adnexal pathology (communicating hydrosalpinx).
-
Background of thrombosis, breast cancer, systemic diseases.
-
Those unable to comprehend the investigational nature of the proposed study.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Instituto Valenciano de Infertilidad Spain | Valencia | Spain | 46015 |
Sponsors and Collaborators
- Instituto Valenciano de Infertilidad, IVI VALENCIA
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 1901-VLC-014-EL