InfertilityPhase 3NCT00064935
Endometrial Biopsy in Infertile Patients
A Phase 3 study testing Endometrial biopsy in people with Infertility, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 8 sites in United States.
Trial 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 woman's menstrual cycle in response to the female hormones estrogen and progesterone. Read more about this study
- Who is it for?
- Ages 25 to 39 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- Endometrial biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 880 participants
- Where
- 8 sitesUnited States
- Study dates
- Apr 1999to Feb 2002
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 39 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- No history of involuntary primary or secondary infertility
- Willingness to discontinue hormonal contraceptives for 1 month prior to and through the duration of the study
- At least 1 child delivered within 24 months prior to study entry
- Most recent pregnancy resulting in a live birth (no interim spontaneous abortions)
- Tubal ligation within 24 months of study entry is acceptable if all other criteria are met
- History of primary or secondary infertility for a period of at least 12 months
- No hormonal treatments in the month preceding study entry
- No history of tubal ligation
Who cannot join
None listed.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
University of Alabama
Birmingham, Alabama, 35249
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
University of Colorado
Denver, Colorado, 80262
Wayne State University
Detroit, Michigan, 48201
Pennsylvania State University
Hershey, Pennsylvania, 17033
Baylor College of Medicine
Houston, Texas, 77030
University of Medicine and Dentistry, NJ
Newark, New Jersey, 07103
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Utility of the Endometrial Biopsy in the Evaluation of the Luteal Phase
When a woman becomes pregnant, the fertilized egg attaches itself to the lining of the uterus (endometrium). The endometrium is constantly changing throughout a woman's 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 (i.e., the endometrium doesn't 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.
Read the 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.
- Conditions
- Infertility
- Being tested
- Endometrial biopsy
- Keywords
- Endometrium, Luteal phase, Endometrial biopsy
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endometrial biopsyProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2003 (estimated)
- Study startApr 1999
- Study completionFeb 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Enrolment
- 880 participants
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Investigators
- Evan Myers, MD, MPH, Principal investigator, Duke University Medical Center and Duke Clinical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00064935
- Sponsor's protocol ID
- U01HD038997
- Other IDs
- U01HD038997, NICHD-0803
- Status last verified
- May 2003
- First submitted
- 15 Jul 2003
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of the Endometrial Biopsy in the Evaluation of the Luteal Phase
- ClinicalTrials.gov ID
- NCT00064935
- Acronym / sponsor ID
- U01HD038997
- Conditions
- Infertility
- Keywords
- Endometrium, Luteal phase, Endometrial biopsy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 880 participants
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- Apr 1999
- Study completion
- Feb 2002
- First posted
- 16 Jul 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
When a woman becomes pregnant, the fertilized egg attaches itself to the lining of the uterus (endometrium). The endometrium is constantly changing throughout a woman's 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 (i.e., the endometrium doesn't 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
Who may qualify
- Ages
- 25 to 39 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- No history of involuntary primary or secondary infertility
- Willingness to discontinue hormonal contraceptives for 1 month prior to and through the duration of the study
- At least 1 child delivered within 24 months prior to study entry
- Most recent pregnancy resulting in a live birth (no interim spontaneous abortions)
- Tubal ligation within 24 months of study entry is acceptable if all other criteria are met
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endometrial biopsy | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Evan Myers, MD, MPH principal investigator
Duke University Medical Center and Duke Clinical Research Institute
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Endometrial biopsy in people with Infertility, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.