Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00064935
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2003-07-15
Brief Title:
Endometrial Biopsy in Infertile Patients
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Study Overview
Official Title:
Utility of the Endometrial Biopsy in the Evaluation of the Luteal Phase
Status:
COMPLETED
Status Verified Date:
2003-05
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:
When a woman becomes pregnant the fertilized egg attaches itself to the lining of the uterus endometrium The endometrium is constantly changing throughout a womans menstrual cycle in response to the female hormones estrogen and progesterone The endometrium must have certain characteristics be at a specific phase in its cycle in order for the fertilized egg to successfully attach Infertility may be caused by an out of phase endometrium ie the endometrium doesnt have the right characteristics when the fertilized egg reaches it The purpose of this study is to evaluate whether the endometrial biopsy is useful in predicting the potential for becoming pregnant and bearing a child
Detailed Description:
This study will evaluate the utility of the endometrial biopsy as a tool for the routine evaluation of the luteal phase of women presenting for infertility evaluation The study will establish whether the mid-luteal or late-luteal phase is the most appropriate time to perform an endometrial biopsy The study will be conducted through the multi-center Reproductive Medicine Network
Women with a history of infertility will be age matched to fertile women controls Women will be randomized either to the mid-luteal phase 7 to 8 days post-ovulation endometrial biopsy group or to the late-luteal phase 12 to 13 days post-ovulation endometrial biopsy group Endometrial specimens will be evaluated histologically by a blinded pathologist
Women with a history of infertility will be age matched to fertile women controls Women will be randomized either to the mid-luteal phase 7 to 8 days post-ovulation endometrial biopsy group or to the late-luteal phase 12 to 13 days post-ovulation endometrial biopsy group Endometrial specimens will be evaluated histologically by a blinded pathologist
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U01HD038997 | NIH | None | None |
| NICHD-0803 | US NIH GrantContract | None | httpsreporternihgovquickSearchU01HD038997 |