- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03322852
Effect of Clomiphene Citrate on Uterine Blood Fow in Women With Unexplained Delayed Conception
October 26, 2017 updated by: Eman Omran, Cairo University
Effect of Clomiphene Citrate on Uterine Hemodynamics in Women With Unexplained Infertility
In a prospective observational study at a university teaching hospital, blood flow indices and serum hormone levels were compared between spontaneous and stimulated cycles in the same group of 50 patients with unexplained delayed conception.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
In a prospective observational study at a university teaching hospital, the mid-luteal (peri-implantation) endometrial thickness and volume, uterine artery pulsatility index (PI) and resistance index (RI), endometrial and subendometrial vascularization index, flow index, and vascularization flow index, and serum estradiol and progesterone levels were compared between spontaneous and clomiphene citrate stimulated cycles in the same group of 50 patients with unexplained infertility.
Study Type
Observational
Enrollment (Actual)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Greater Cairo
-
Cairo, Greater Cairo, Egypt, 11956
- Department of Obstetrics and Gynecology, Kasr Al-Ainy hospital, Cairo University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 35 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Patients who had unexplained infertility
Description
Inclusion Criteria:
- Unexplained infertility
- Body mass index less than 30
- Regular menstruation
- Normal pelvic examination and ultrasonography
Exclusion Criteria:
- History of pelvic operations including cesarean section
- History of pelvic inflammatory disease
- Endometriosis
- Pelvic pathology including uterine fibroids
- General disease or medication that could potentially affect pelvic blood flow
- Smoking
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Crossover
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Flow index of the endometrial region
Time Frame: Day 22 to 24 of the menstrual cycle
|
Flow index of the endometrial region was measured by a researcher
|
Day 22 to 24 of the menstrual cycle
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Vascularization index of the endometrial region
Time Frame: Day 22 to 24 of the menstrual cycle
|
Vascularization index of the endometrial region was measured by a researcher
|
Day 22 to 24 of the menstrual cycle
|
Vascularization flow index of the endometrial region
Time Frame: Day 22 to 24 of the menstrual cycle
|
Vascularization flow index of the endometrial region was measured by a researcher
|
Day 22 to 24 of the menstrual cycle
|
Vascularization flow index of the sub-endometrial region
Time Frame: Day 22 to 24 of the menstrual cycle
|
Vascularization flow index of the sub-endometrial region was measured by a researcher
|
Day 22 to 24 of the menstrual cycle
|
Flow index of the sub-endometrial region
Time Frame: Day 22 to 24 of the menstrual cycle
|
Flow index of the sub-endometrial region was measured by a researcher
|
Day 22 to 24 of the menstrual cycle
|
Vascularization index of the sub-endometrial region
Time Frame: Day 22 to 24 of the menstrual cycle
|
Vascularization index of the sub-endometrial region was measured by a researcher
|
Day 22 to 24 of the menstrual cycle
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Eman Omran, M.D., Cairo University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2014
Primary Completion (Actual)
October 1, 2016
Study Completion (Actual)
October 30, 2016
Study Registration Dates
First Submitted
October 24, 2017
First Submitted That Met QC Criteria
October 24, 2017
First Posted (Actual)
October 26, 2017
Study Record Updates
Last Update Posted (Actual)
October 27, 2017
Last Update Submitted That Met QC Criteria
October 26, 2017
Last Verified
October 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4588
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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