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

Infertility, Female Clinical Trial

— PROGENDO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04499131
• Other study ID #: 1901-VLC-014-EL
• Status: Recruiting
• Phase: Phase 4
• Start date: December 9, 2021
• Est. completion date: December 2024

Study information

• Verified date: February 2023
• Source: Instituto Valenciano de Infertilidad, IVI VALENCIA
• Contact: LAURA CARACENA
• Phone: 963050999
• Email: Laura.Caracena[@]ivirma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• ENDOMETRIAL RECEPTIVITY
• Infertility
• Infertility, Female

Intervention

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 15 subjects in the context of a natural cycle with only endogenous progesterone present

Locations

Country	Name	City	State
Spain	Instituto Valenciano de Infertilidad Spain	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Valenciano de Infertilidad, IVI VALENCIA

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endometrial gene expression profile	Determination of gene expression	12 months
Secondary	Histological dating of endometrial biopsies	Endometrial classification using Noyes criteria	12 months
Secondary	Histological analysis of the endometrial tissue using electron microscopy	Presence or Absence of Pinopodes	12 months
Secondary	Progesterone concentration in the endometrium	Endometrial progesterone values	12 months
Secondary	Serum Progesterone concentrations	Blood serum progesterone values	12 months
Secondary	Correlation between progesterone levels in blood and uterus.	Presence or Absence of correlation	12 months
Secondary	Correlation between serum and uterine levels with endometrial transcriptome and histological dating	Presence or Absence of correlation	12 months