Ignite Creation Date:
2025-12-24 @ 9:17 PM
Ignite Modification Date:
2026-03-14 @ 10:51 AM
Study NCT ID:
NCT02458404
Status:
COMPLETED
Last Update Posted:
2019-11-07
First Post:
2015-03-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Varied Estrogen Doses on Endometrial Receptivity
Sponsor:
Reproductive Medicine Associates of New Jersey
Organization:
Study Overview
Official Title:
Effects of Varied Estrogen Doses on Endometrial Receptivity
Status:
COMPLETED
Status Verified Date:
2019-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will help determine the effect of varied estradiol levels on the uterine lining in healthy humans that are not undergoing a stimulated in vitro fertilization (IVF) cycle.
Detailed Description:
Volunteers who wish to participate in the study, will undergo a diagnostic and screening phase to determine their eligibility. Once eligibility is determined, participants will undergo three, separate "endometrial preparatory cycles". These cycles will consist of estrogen supplementation to mimic normal, above normal, and highly elevated estradiol levels. Once supplementation is complete uterine procedures will be done to hopefully determine the effects of the estrogen levels on the uterine lining. Subcutaneous leuprolide injections, intramuscular estrogen, and progesterone injections will be used to mimic the levels needed. Blood draws will monitor the needed estradiol and progesterone levels during the injection phase of the cycle. Once the injection phase is complete, transvaginal ultrasound, uterine aspiration, and endometrial biopsy will be done.
Study Oversight
Has Oversight DMC:
False
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?: