Skip to main content
OpenTrials
Completed

NCT Number: NCT04499131

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Infertility, Female ENDOMETRIAL RECEPTIVITY Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infertility Urogenital Diseases

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Instituto Valenciano de Infertilidad Spain

Valencia, 46015, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

  • Age: 18-35 years old, both inclusive
  • Regular menstrual cycles
  • 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:

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

Treatment and study plan

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

Primary outcomes

  1. Endometrial gene expression profile

    Time frame: 12 months

    Determination of gene expression

Secondary outcomes

  1. Histological dating of endometrial biopsies

    Time frame: 12 months

    Endometrial classification using Noyes criteria

  2. Progesterone concentration in the endometrium

    Time frame: 12 months

    Endometrial progesterone values

  3. Serum Progesterone concentrations

    Time frame: 12 months

    Blood serum progesterone values

  4. Correlation between progesterone levels in blood and uterus.

    Time frame: 12 months

    Presence or Absence of correlation

  5. Correlation between serum and uterine levels with endometrial transcriptome and histological dating

    Time frame: 12 months

    Presence or Absence of correlation

Sponsors and collaborators

Lead sponsor

Instituto Valenciano de Infertilidad, IVI VALENCIA

Other

Registry information

Official study 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

Acronym: PROGENDO

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Aug 5, 2020
Registry last updated
Feb 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.