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

Phase 4

Recruiting

• Conditions: Infertility, Female; ENDOMETRIAL RECEPTIVITY
• Interventions: Drug: Progesterone; Other: Artificial Cycle (no intervention)

• Registration Number: NCT04499131
• Lead Sponsor: Instituto Valenciano de Infertilidad, IVI VALENCIA

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-30
• Study First Submitted QC: 2020-07-30
• Study First Posted: 2020-08-05
• Study Start: 2021-12-09
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-02
• Last Update Posted: 2024-10-04
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 108

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
II: Artificial endometrial preparation cycle	Progesterone	Artificial endometrial preparation cycle with estrogens and subcutaneous natural progesterone 25mg/24h
III: Artificial endometrial preparation cycle	Progesterone	Artificial endometrial preparation cycle with estrogens and subcutaneous natural progesterone 25mg/12h
IV: Artificial endometrial preparation cycle	Progesterone	Artificial endometrial preparation cycle with estrogens and a combination of subcutaneous natural progesterone 25mg/24h + vaginal natural micronized progesterone 400mg/24h
Natural menstrual cycle	Artificial Cycle (no intervention)	Natural menstrual cycle (without any exogenous steroid hormone Treatment)
I: Artificial endometrial preparation cycle	Progesterone	Artificial endometrial preparation cycle with estrogens and vaginal natural micronized progesterone 400mg/12h
V: Artificial endometrial preparation cycle	Progesterone	Artificial endometrial preparation cycle with estrogens and intramuscular natural progesterone 50mg/24h

Primary Outcome Measures

Name	Time	Method
Endometrial gene expression profile	12 months	Determination of gene expression

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Instituto Valenciano de Infertilidad Spain; 🇪🇸 Valencia, Spain