Infertility, FemalePhase 4PROGENDONCT04499131

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

A Phase 4 study testing Progesterone in people with Infertility, Female and ENDOMETRIAL RECEPTIVITY, run by Instituto Valenciano de Infertilidad, IVI VALENCIA at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 35 years, women onlyHealthy volunteers can take part
Conditions the study is for: Infertility, Female, ENDOMETRIAL RECEPTIVITY
What is being tested?: Progesterone
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 109 participants
Where: 1 siteSpain
Study dates: 9 Dec 2021to 31 Dec 2025
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 35 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Spain1 site

Instituto Valenciano de Infertilidad Spain
Valencia, Valencia, 46015

Other trials in Spain

About this study

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

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
Being tested: Progesterone, Artificial Cycle (no intervention)
Keywords: Luteal phase, Artificial endometrial preparation cycle, Progesterone, Endometrial gene expression, Endometrial receptivity
Medical subject headings: Infertility, Female

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ProgesteroneDrug
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

Study groups in NCT04499131
Study group	Role	What they receive
I: Artificial endometrial preparation cycle	Experimental	Artificial endometrial preparation cycle with estrogens and vaginal natural micronized progesterone 400mg/12h Receives: Drug: Progesterone
II: Artificial endometrial preparation cycle	Experimental	Artificial endometrial preparation cycle with estrogens and subcutaneous natural progesterone 25mg/24h Receives: Drug: Progesterone
III: Artificial endometrial preparation cycle	Experimental	Artificial endometrial preparation cycle with estrogens and subcutaneous natural progesterone 25mg/12h Receives: Drug: Progesterone
IV: Artificial endometrial preparation cycle	Experimental	Artificial endometrial preparation cycle with estrogens and a combination of subcutaneous natural progesterone 25mg/24h + vaginal natural micronized progesterone 400mg/24h Receives: Drug: Progesterone
V: Artificial endometrial preparation cycle	Experimental	Artificial endometrial preparation cycle with estrogens and intramuscular natural progesterone 50mg/24h Receives: Drug: Progesterone
Natural menstrual cycle	Active comparator	Natural menstrual cycle (without any exogenous steroid hormone Treatment) Receives: Other: Artificial Cycle (no intervention)

What is being measured

The primary outcome is the main question the study is designed to answer.

Endometrial gene expression profile
Determination of gene expression
Measured: 12 months

Secondary outcomes (5)

Histological dating of endometrial biopsies
Endometrial classification using Noyes criteria
Measured: 12 months
Progesterone concentration in the endometrium
Endometrial progesterone values
Measured: 12 months
Serum Progesterone concentrations
Blood serum progesterone values
Measured: 12 months
Correlation between progesterone levels in blood and uterus.
Presence or Absence of correlation
Measured: 12 months
Correlation between serum and uterine levels with endometrial transcriptome and histological dating
Presence or Absence of correlation
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Dec 202131 Dec 2025

First posted5 Aug 2020
Study start9 Dec 2021
Primary completion30 Apr 2025
Study completion31 Dec 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Infertility, FemaleStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
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.
Masking: Single blind
Who is masked: Investigator
Enrolment: 109 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04499131
Sponsor's protocol ID: 1901-VLC-014-EL
Acronym: PROGENDO
Status last verified: Jan 2026
First submitted: 30 Jul 2020
Last updated: 3 Feb 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04499131
Acronym / sponsor ID: PROGENDO / 1901-VLC-014-EL
Conditions: Infertility, Female, ENDOMETRIAL RECEPTIVITY
Keywords: Luteal phase, Artificial endometrial preparation cycle, Progesterone, Endometrial gene expression, Endometrial receptivity
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 109 participants (actual)
Lead sponsor: Instituto Valenciano de Infertilidad, IVI VALENCIAUniversity, hospital or other
Study start: 9 Dec 2021 (actual)
Primary completion: 30 Apr 2025 (actual)
Study completion: 31 Dec 2025 (actual)
First posted: 5 Aug 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 6
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.

Arm	Type	Receives
I: Artificial endometrial preparation cycle	Experimental	Drug: ProgesteroneArtificial endometrial preparation cycle with estrogens and vaginal natural micronized progesterone 400mg/12h
II: Artificial endometrial preparation cycle	Experimental	Drug: ProgesteroneArtificial endometrial preparation cycle with estrogens and subcutaneous natural progesterone 25mg/24h
III: Artificial endometrial preparation cycle	Experimental	Drug: ProgesteroneArtificial endometrial preparation cycle with estrogens and subcutaneous natural progesterone 25mg/12h
IV: Artificial endometrial preparation cycle	Experimental	Drug: ProgesteroneArtificial endometrial preparation cycle with estrogens and a combination of subcutaneous natural progesterone 25mg/24h + vaginal natural micronized progesterone 400mg/24h
V: Artificial endometrial preparation cycle	Experimental	Drug: ProgesteroneArtificial endometrial preparation cycle with estrogens and intramuscular natural progesterone 50mg/24h
Natural menstrual cycle	Active comparator	Other: Artificial Cycle (no intervention)Natural menstrual cycle (without any exogenous steroid hormone Treatment)

Who may qualify

Ages: 18 to 35 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (6 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ProgesteroneSubjects 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.	Drug	I: Artificial endometrial preparation cycle, II: Artificial endometrial preparation cycle, III: Artificial endometrial preparation cycle, IV: Artificial endometrial preparation cycle, V: Artificial endometrial preparation cycle
Artificial Cycle (no intervention)Control group of 19 subjects in the context of a natural cycle with only endogenous progesterone present	Other	Natural menstrual cycle

Primary outcome

Endometrial gene expression profile
Time frame: 12 months
Determination of gene expression

5 secondary outcomes

Histological dating of endometrial biopsies
Time frame: 12 months
Progesterone concentration in the endometrium
Time frame: 12 months
Serum Progesterone concentrations
Time frame: 12 months
Correlation between progesterone levels in blood and uterus.
Time frame: 12 months
Correlation between serum and uterine levels with endometrial transcriptome and histological dating
Time frame: 12 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Progesterone in people with Infertility, Female and ENDOMETRIAL RECEPTIVITY, run by Instituto Valenciano de Infertilidad, IVI VALENCIA at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Endometrial gene expression profile (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04499131.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2026.