deltatrials
Completed EARLY_PHASE1 INTERVENTIONAL 4-arm NCT06616077

Endometrial Transcript Profile with Progesterone After Post-ovulatory Mifepristone

Determinaton of Changes in the Endometrial Gene Expression Profile Induced by Exogenous Progesterone After Post-ovulatory Administration of Mifepristone

Sponsor: Reproductive Health Research Insritute, Chile

Updated 2 times since 2024 Last updated: Sep 24, 2024 Started: Jun 7, 2022 Primary completion: Apr 27, 2023 Completion: May 8, 2023
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This EARLY_PHASE1 trial investigates Endometrial Endocrine Regulation and Progesterone Supplementation in Women After Mifepristone and is currently completed. Reproductive Health Research Insritute, Chile leads this study, which shows 2 recorded versions since 2022 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Study Description(click to expand)

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.

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.

Status Flow

~Oct 2024 – present · 18 months · monthly snapshotCompleted~Jan 2026 – present · 3 months · monthly snapshotCompleted

Change History

2 versions recorded
  1. Jan 2026 — Present [monthly]

    Completed EARLY_PHASE1

  2. Oct 2024 — Present [monthly]

    Completed EARLY_PHASE1

    First recorded

Jun 2022

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Reproductive Health Research Insritute, Chile
Data source: Reproductive Health Research Insritute, Chile

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations