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

Status: Recruiting
Location: See location...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 35
Healthy Volunteers: t
View:

⁃ 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.

Locations
Other Locations
Spain
Instituto Valenciano de Infertilidad Spain
RECRUITING
Valencia
Contact Information
Primary
LAURA CARACENA
Laura.Caracena@ivirma.com
+34 963050999
Time Frame
Start Date: 2021-12-09
Estimated Completion Date: 2025-12
Participants
Target number of participants: 108
Treatments
Experimental: I: Artificial endometrial preparation cycle
Artificial endometrial preparation cycle with estrogens and vaginal natural micronized progesterone 400mg/12h
Experimental: II: Artificial endometrial preparation cycle
Artificial endometrial preparation cycle with estrogens and subcutaneous natural progesterone 25mg/24h
Experimental: III: Artificial endometrial preparation cycle
Artificial endometrial preparation cycle with estrogens and subcutaneous natural progesterone 25mg/12h
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
Experimental: V: Artificial endometrial preparation cycle
Artificial endometrial preparation cycle with estrogens and intramuscular natural progesterone 50mg/24h
Active_comparator: Natural menstrual cycle
Natural menstrual cycle (without any exogenous steroid hormone Treatment)
Related Therapeutic Areas
Sponsors
Leads: Instituto Valenciano de Infertilidad, IVI VALENCIA

This content was sourced from clinicaltrials.gov