Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06616077
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-17
Brief Title:
Endometrial Transcript Profile with Progesterone After Post-ovulatory Mifepristone
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Determinaton of Changes in the Endometrial Gene Expression Profile Induced by Exogenous Progesterone After Post-ovulatory Administration of Mifepristone
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
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 LH2 LH0LH peak Endometrial samples were obtained on LH7 after vaginal administration of micronized progesterone 600mgday for 3 days LH3 to LH5 Each woman contributed with one cycle treated with placebo and another with progesterone group A Additionally endometrial samples were obtained on LH7 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
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 LH2 LH0LH peak Endometrial samples were obtained on LH7 after vaginal administration of micronized progesterone 600mgday for 3 days LH3 to LH5 Each woman contributed with one cycle treated with placebo and another with progesterone group A Additionally endometrial samples were obtained on LH7 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None