Impact of Different Doses and Routes of Exogenous Progesterone Administration on Endometrial Receptivity Parameters

NCT04499131 — Phase 4, Completed, 109 participants, Instituto Valenciano de Infertilidad, IVI VALENCIA

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Exploratory Study on the Impact of Different Doses and Route of Administration of Exogenous Progesterone in Artificial Endometrial Preparation Cycles on Endometrial Structure and Function

Registry	NCT04499131, acronym PROGENDO
Status	Completed
Phase	Phase 4
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	109 (Actual)
Sponsor	Instituto Valenciano de Infertilidad, IVI VALENCIA (Other)
Conditions	Infertility, Female, ENDOMETRIAL RECEPTIVITY
Interventions	Progesterone, Artificial Cycle (no intervention) (Drug, other)
Dates	start 2021-12-09, primary completion 2025-04-30, completion 2025-12-31, first posted 2020-08-05, last updated 2026-02-03
Locations	1 site in Spain

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
I: Artificial endometrial preparation cycle	Experimental	Drug: Progesterone	Artificial endometrial preparation cycle with estrogens and vaginal natural micronized progesterone 400mg/12h
II: Artificial endometrial preparation cycle	Experimental	Drug: Progesterone	Artificial endometrial preparation cycle with estrogens and subcutaneous natural progesterone 25mg/24h
III: Artificial endometrial preparation cycle	Experimental	Drug: Progesterone	Artificial endometrial preparation cycle with estrogens and subcutaneous natural progesterone 25mg/12h
IV: Artificial endometrial preparation cycle	Experimental	Drug: Progesterone	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	Drug: Progesterone	Artificial endometrial preparation cycle with estrogens and intramuscular natural progesterone 50mg/24h
Natural menstrual cycle	Active comparator	Other: Artificial Cycle (no intervention)	Natural menstrual cycle (without any exogenous steroid hormone Treatment)

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.
Artificial Cycle (no intervention) (Other): Control group of 19 subjects in the context of a natural cycle with only endogenous progesterone present

+Outcome measures

Primary outcomes

Endometrial gene expression profile [12 months]: Determination of gene expression

Secondary outcomes

Histological dating of endometrial biopsies [12 months]: Endometrial classification using Noyes criteria
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

Sex: Female, ages: 18 Years to 35 Years, accepts healthy volunteers

Inclusion Criteria

All women with no history of infertility who agree to participate in the study:

1. Age: 18-35 years old, both inclusive
2. Regular menstrual cycles
3. 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:

1. Simultaneous participation in other clinical studies that, at the researcher's criteria, could interfere with the results of this study.
2. Taking oral contraceptives in the three months prior to signing informed consent.
3. Presence of uterine pathology (submucosal or intramural myomas >4 cm deforming cavity, endometrial polyps or müllerian anomalies) or adnexal pathology (communicating hydrosalpinx).
4. Background of thrombosis, breast cancer, systemic diseases.
5. Those unable to comprehend the investigational nature of the proposed study.

+Locations (1)

Facility	City	Country	Status
Instituto Valenciano de Infertilidad Spain	Valencia, Valencia	Spain