Infertility, FemaleNCT03322852
Effect of Clomiphene Citrate on Uterine Blood Fow in Women With Unexplained Delayed Conception
An observational study of Infertility, Female, run by Cairo University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 25 to 35 years, women only
- Conditions the study is for
- Infertility, Female
- What is being tested?
- Vascularization indices observation
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2014to 30 Oct 2016
- Phase
- Observational
- 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 35 years
- Women only
- No healthy volunteers
- Adult
Study population: Patients who had unexplained infertility
Who may be able to join
- Unexplained infertility
- Body mass index less than 30
- Regular menstruation
- Normal pelvic examination and ultrasonography
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Department of Obstetrics and Gynecology, Kasr Al-Ainy hospital, Cairo University
Cairo, Greater Cairo, 11956
About this study
Official title: 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.
Read the 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.
- Conditions
- Infertility, Female
- Being tested
- Vascularization indices observation
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vascularization indices observationOther
The mid-luteal endometrial thickness and volume, uterine vascularization indices of uterine artery pulsatility index and resistance index, endometrial and subendometrial vascularization index, flow index, and vascularization flow index, and serum estradiol and progesterone levels were calculated in spontaneous then stimulated cycles in the same group of infertile patients
What is being measured
The primary outcome is the main question the study is designed to answer.
Flow index of the endometrial region
Flow index of the endometrial region was measured by a researcher
Measured: Day 22 to 24 of the menstrual cycle
Secondary outcomes (5)
Vascularization index of the endometrial region
Vascularization index of the endometrial region was measured by a researcher
Measured: Day 22 to 24 of the menstrual cycle
Vascularization flow index of the endometrial region
Vascularization flow index of the endometrial region was measured by a researcher
Measured: Day 22 to 24 of the menstrual cycle
Vascularization flow index of the sub-endometrial region
Vascularization flow index of the sub-endometrial region was measured by a researcher
Measured: Day 22 to 24 of the menstrual cycle
Flow index of the sub-endometrial region
Flow index of the sub-endometrial region was measured by a researcher
Measured: Day 22 to 24 of the menstrual cycle
Vascularization index of the sub-endometrial region
Vascularization index of the sub-endometrial region was measured by a researcher
Measured: Day 22 to 24 of the menstrual cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2017
- Study start1 Oct 2014
- Primary completion1 Oct 2016
- Study completion30 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, FemaleStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Omran, Cairo University
- Investigators
- Eman Omran, M.D., Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03322852
- Sponsor's protocol ID
- 4588
- Status last verified
- Oct 2017
- First submitted
- 24 Oct 2017
- Last updated
- 27 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Clomiphene Citrate on Uterine Hemodynamics in Women With Unexplained Infertility
- ClinicalTrials.gov ID
- NCT03322852
- Acronym / sponsor ID
- 4588
- Conditions
- Infertility, Female
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Oct 2014 (actual)
- Primary completion
- 1 Oct 2016 (actual)
- Study completion
- 30 Oct 2016 (actual)
- First posted
- 26 Oct 2017 (actual)
- 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.
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.
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 design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients who had unexplained infertility
Key inclusion criteria (4 listed)
- Unexplained infertility
- Body mass index less than 30
- Regular menstruation
- Normal pelvic examination and ultrasonography
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Vascularization indices observationThe mid-luteal endometrial thickness and volume, uterine vascularization indices of uterine artery pulsatility index and resistance index, endometrial and subendometrial vascularization index, flow index, and vascularization flow index, and serum estradiol and progesterone levels were calculated in spontaneous then stimulated cycles in the same group of infertile patients | Other | – |
Primary outcome
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
5 secondary outcomes
Vascularization index of the endometrial region
Time frame: 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 sub-endometrial region
Time frame: 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
Vascularization index of the sub-endometrial region
Time frame: Day 22 to 24 of the menstrual cycle
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 27 Oct 2017.
- Individual participant dataSharing planned: Undecided
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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.
Eman Omran, M.D. principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, Female, run by Cairo University at 1 site in Egypt.
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 4 inclusion and 6 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 27 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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.
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.
What does the primary outcome measure?
Flow index of the endometrial region (time frame: Day 22 to 24 of the menstrual cycle). It is what the study was designed to measure, not a finding.
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 27 Oct 2017.