A Phase 4 interventional study of Progesterone and Artificial Cycle (no intervention) in Infertility, Female and ENDOMETRIAL RECEPTIVITY, sponsored by Instituto Valenciano de Infertilidad, IVI VALENCIA. Completed at 1 site in Spain. Open to female participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-03.
Sponsored by Instituto Valenciano de Infertilidad, IVI VALENCIA · Phase 4, Interventional, and Treatment
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.
540 studies on the registry are indexed under Infertility, Female; 138 are open to participants now.
This study's enrollment of 109 is close to the median of 100 across 371 interventional studies indexed under Infertility, Female.
Browse Infertility, Female studies →Instituto Valenciano de Infertilidad, IVI VALENCIA is the lead sponsor of 70 studies on the registry; 8 are open to participants now.
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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:
Artificial endometrial preparation cycle with estrogens and vaginal natural micronized progesterone 400mg/12h
Drug: Progesterone
Artificial endometrial preparation cycle with estrogens and subcutaneous natural progesterone 25mg/24h
Drug: Progesterone
Artificial endometrial preparation cycle with estrogens and subcutaneous natural progesterone 25mg/12h
Drug: Progesterone
Artificial endometrial preparation cycle with estrogens and a combination of subcutaneous natural progesterone 25mg/24h + vaginal natural micronized progesterone 400mg/24h
Drug: Progesterone
Artificial endometrial preparation cycle with estrogens and intramuscular natural progesterone 50mg/24h
Drug: Progesterone
Natural menstrual cycle (without any exogenous steroid hormone Treatment)
Other: Artificial Cycle (no intervention)
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.
Control group of 19 subjects in the context of a natural cycle with only endogenous progesterone present
Endometrial gene expression profile
Determination of gene expression
Time frame: 12 months
Histological dating of endometrial biopsies
Endometrial classification using Noyes criteria
Time frame: 12 months
Progesterone concentration in the endometrium
Endometrial progesterone values
Time frame: 12 months
Serum Progesterone concentrations
Blood serum progesterone values
Time frame: 12 months
Correlation between progesterone levels in blood and uterus.
Presence or Absence of correlation
Time frame: 12 months
Correlation between serum and uterine levels with endometrial transcriptome and histological dating
Presence or Absence of correlation
Time frame: 12 months
Plan to share: Undecided
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This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Instituto Valenciano de Infertilidad, IVI VALENCIA