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

Sponsor
Instituto Valenciano de Infertilidad, IVI VALENCIA (Other)
Overall Status
Recruiting
CT.gov ID
NCT04499131
Collaborator
(none)
90
1
6
11.7
7.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Exploratory, unicentric, with blind evaluators, randomized to six parallel arms in ratio 1:1:1:1:1:1 clinical trial conducted in healthy volunteers under an artificial endometrial preparation cycle and luteal phase support with exogenous progesterone administered by different doses and routes or natural menstrual cycles.Exploratory, unicentric, with blind evaluators, randomized to six parallel arms in ratio 1:1:1:1:1:1 clinical trial conducted in healthy volunteers under an artificial endometrial preparation cycle and luteal phase support with exogenous progesterone administered by different doses and routes or natural menstrual cycles.
Masking:
Single (Investigator)
Masking Description:
Patients will be evaluated by blinded gynecologist in order to prevent the application of personal criteria and protect the consistence of the study.
Primary Purpose:
Treatment
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
Actual Study Start Date :
Dec 9, 2021
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: I: Artificial endometrial preparation cycle

Artificial endometrial preparation cycle with estrogens and vaginal natural micronized progesterone 400mg/12h

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.

Experimental: II: Artificial endometrial preparation cycle

Artificial endometrial preparation cycle with estrogens and subcutaneous natural progesterone 25mg/24h

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.

Experimental: III: Artificial endometrial preparation cycle

Artificial endometrial preparation cycle with estrogens and subcutaneous natural progesterone 25mg/12h

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.

Experimental: IV: Artificial endometrial preparation cycle

Artificial endometrial preparation cycle with estrogens and a combination of subcutaneous natural progesterone 25mg/24h + vaginal natural micronized progesterone 400mg/24h

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.

Experimental: V: Artificial endometrial preparation cycle

Artificial endometrial preparation cycle with estrogens and intramuscular natural progesterone 50mg/24h

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.

Active Comparator: Natural menstrual cycle

Natural menstrual cycle (without any exogenous steroid hormone Treatment)

Other: Artificial Cycle (no intervention)
Control group of 15 subjects in the context of a natural cycle with only endogenous progesterone present

Outcome Measures

Primary Outcome Measures

  1. Endometrial gene expression profile [12 months]

    Determination of gene expression

Secondary Outcome Measures

  1. Histological dating of endometrial biopsies [12 months]

    Endometrial classification using Noyes criteria

  2. Histological analysis of the endometrial tissue using electron microscopy [12 months]

    Presence or Absence of Pinopodes

  3. Progesterone concentration in the endometrium [12 months]

    Endometrial progesterone values

  4. Serum Progesterone concentrations [12 months]

    Blood serum progesterone values

  5. Correlation between progesterone levels in blood and uterus. [12 months]

    Presence or Absence of correlation

  6. Correlation between serum and uterine levels with endometrial transcriptome and histological dating [12 months]

    Presence or Absence of correlation

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 35 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes

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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Instituto Valenciano de Infertilidad Spain Valencia Spain 46015

Sponsors and Collaborators

  • Instituto Valenciano de Infertilidad, IVI VALENCIA

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Instituto Valenciano de Infertilidad, IVI VALENCIA
ClinicalTrials.gov Identifier:
NCT04499131
Other Study ID Numbers:
  • 1901-VLC-014-EL
First Posted:
Aug 5, 2020
Last Update Posted:
Jan 6, 2022
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Instituto Valenciano de Infertilidad, IVI VALENCIA
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 6, 2022