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

NCT ID: NCT04499131

Last Updated: 2024-10-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-09
• Study Completion Date: 2025-12-31

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.

Conditions

Infertility, Female; ENDOMETRIAL RECEPTIVITY

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

I: Artificial endometrial preparation cycle

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

Group Type: EXPERIMENTAL

Progesterone

Intervention Type: 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.

II: Artificial endometrial preparation cycle

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

Group Type: EXPERIMENTAL

Progesterone

Intervention Type: 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.

III: Artificial endometrial preparation cycle

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

Group Type: EXPERIMENTAL

Progesterone

Intervention Type: 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.

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

Group Type: EXPERIMENTAL

Progesterone

Intervention Type: 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.

V: Artificial endometrial preparation cycle

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

Group Type: EXPERIMENTAL

Progesterone

Intervention Type: 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.

Natural menstrual cycle

Natural menstrual cycle (without any exogenous steroid hormone Treatment)

Group Type: ACTIVE_COMPARATOR

Artificial Cycle (no intervention)

Intervention Type: OTHER

Control group of 19 subjects in the context of a natural cycle with only endogenous progesterone present

Interventions

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.

Intervention Type: DRUG

Artificial Cycle (no intervention)

Control group of 19 subjects in the context of a natural cycle with only endogenous progesterone present

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Instituto Valenciano de Infertilidad, IVI VALENCIA

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Instituto Valenciano de Infertilidad Spain

Valencia, Valencia, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

LAURA CARACENA

Role: CONTACT

Laura.Caracena@ivirma.com

+34 963050999 ext. 11054

Facility Contacts

ELENA LABARTA, MD

Role: primary

elabarta@ivirma.com

34 96 3050900

Ernesto Bosch, MD

Role: backup

Elena Labarta, MD

Role: backup

Pilar Alama, MD

Role: backup

Josep Lluis Romero, MD

Role: backup

Patricia Diaz-Gimeno, MD

Role: backup

Patricia Sebastian, MD

Role: backup

Cristina Rodríguez

Role: backup

Other Identifiers

1901-VLC-014-EL

Identifier Type: -

Identifier Source: org_study_id