NCT04499131

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 109 (actual)
• Sponsor: Instituto Valenciano de Infertilidad, IVI VALENCIA · Academic / Other
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

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.

Conditions

• Infertility, Female
• ENDOMETRIAL RECEPTIVITY

Interventions

Type	Name	Description
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.
OTHER	Artificial Cycle (no intervention)	Control group of 19 subjects in the context of a natural cycle with only endogenous progesterone present

Timeline

• Start date: 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 across 1 country: Spain