Hospital San Borja Arriarán
Santiago, Santiago Metropolitan, 8360160, Chile
Completed
NCT Number: NCT06616077
Endometrial Transcript Profile with Progesterone After Post-ovulatory Mifepristone
The goal of this exploratory trial is to determine the endometrial gene expression profile induced by exogenous progesterone after postovulatory administration of mifepristone. It will also learn about the plasticity ofr the endometrial response to progesterone. The main questions it aims to answer are:
Is exogenous progesterone able to modulate the gene expression of endometrial transcripts that have been altered by mifepristone?
Researchers will compare the endometrial gene expression profiles with exogeonous progesterone to a placebo (a look-alike substance that contains no drug) after postovulatory administration of mifepristone.
Participants will:
Do ovulation follow-up tests at home assesing LH in urine Visit the hospital 2 days after a positive LH for mifepristone administration and ultrasonography check of ovaries and uterus.
Starting from the next day, take progesterone or placebo for 3 days. Visit the hospital 2 days after that for ultrasonography check of ovaries and uterus and for an endometrial and blood sample collection.
The endometrial samples will be processed to isolate the RNA and for histological assessment. Gene expression profiles will be determined by RNA-seq.
Completed
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Conditions
Age range
18 year–43 year
Sex eligibility
Female
Study type
Interventional
Phase
Early Phase 1
Primary location
About this study
Objective: To determine the effect of progesterone supplementation on the mid-secretory endometrial transcript profile after postovulatory administration of mifepristone.
Design: A randomized, double-blind, placebo-controlled study. Setting: Tertiary academic medical center Subjects: A total of 9 Hispanic women of proven fertility who had been surgically sterilized.
Interventions: Participating women received a single dose of mifepristone 200mg 48 hours after the LH peak (LH+2, LH+0=LH peak). Endometrial samples were obtained on LH+7 after vaginal administration of micronized progesterone (600mg/day) for 3 days (LH+3 to LH+5). Each woman contributed with one cycle treated with placebo and another with progesterone (group A). Additionally, endometrial samples were obtained on LH+7 from subset of 4 women who did not receive mifepristone; with each one contributing with one cycle treated with vaginal progesterone supplementation or placebo as a reference (group B). Endometrial thickness, circulating progesterone levels, and endometrial histology were also documented in all cycles. RNA-seq was used to identify genes whose transcript levels significantly changed by the administration of progesterone versus placebo, with postovulatory administration of mifepristone. The transcript profiles of these genes were further evaluated in the endometrial samples from group B.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- proven fertility
- regular menstrual cycles
- surgically sterilized at least one year before participating in the protocol
Exclusion criteria
- chronic medical problems
- abnormal results of screening blood tests
- ovarian masses
- symptomatic endometriosis
- uterine leiomyomata
- being under chronic medication or taking hormones or drugs able to modify the metabolism of steroid hormones in the 3 preceding months to study enrollment
Treatment and study plan
Micronized Progesterone 600 mg
DrugVaginal supplementary micronized progesterone will be given after postovulatory administration of the progesterone receptor antagonist mifepristone. Administration from LH+3 to LH+5 (LH peak=LH+0); 200 mg 3 times per day.
Other names: Progendo
mifepristone 200 mg
DrugPost ovulatory single oral administration (LH+2, LH peak=LH+0)
Other names: MIFEAPROFA
Oral Placebo Tablet
DrugOral placebo tablet containing brewer yeast, cellulose, stearic acid, silica, magnesium stearate
Placebo Vaginal
DrugCocoa butter
Primary outcomes
-
Endometrial Gene Expression Profile
Time frame: From enrollment to the end of treatments after aproximately 12 weeks
RNA-seq gene expression in the midluteal phase
Secondary outcomes
-
Endometrial dating
Time frame: From enrollment to the end of treatments after aproximately 8 months
Estimated cycle day based on endometrial morphology according to the Noyes criteria
Other outcomes
-
Uterine ultrasonographic features
Time frame: From enrrollment to the end of treatments after 12 weeks
Will be evaluated the ultrasonographic features such as hypo- and hyper- echogenecity
-
Circulating progesterone levels
Time frame: From enrollment to after the treatments after 12 weeks
Will be evaluated the cirduating levels of progesterone on day LH+7 (LH+0=LH peak) in women that have taken postovulatory mifepristone plus exogenous progesterone or placebo.
Sponsors and collaborators
Lead sponsor
Reproductive Health Research Insritute, Chile
Other
Registry information
Official study title
Determinaton of Changes in the Endometrial Gene Expression Profile Induced by Exogenous Progesterone After Post-ovulatory Administration of Mifepristone
Important dates
- Study start
- 2022
- Primary completion
- 2023
- Study completion
- 2023
- First posted
- Sep 27, 2024
- Registry last updated
- Sep 27, 2024
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.