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Effect of Clomiphene Citrate on Uterine Blood Fow in Women With Unexplained Delayed Conception

Sponsor
Cairo University (Other)
Overall Status
Completed
CT.gov ID
NCT03322852
Collaborator
(none)
50
Enrollment
1
Location
25
Actual Duration (Months)
2
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Vascularization indices observation

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

Study Type:
Observational
Actual Enrollment :
50 participants
Observational Model:
Case-Crossover
Time Perspective:
Prospective
Official Title:
Effect of Clomiphene Citrate on Uterine Hemodynamics in Women With Unexplained Infertility
Actual Study Start Date :
Oct 1, 2014
Actual Primary Completion Date :
Oct 1, 2016
Actual Study Completion Date :
Oct 30, 2016

Outcome Measures

Primary Outcome Measures

  1. Flow index of the endometrial region [Day 22 to 24 of the menstrual cycle]

    Flow index of the endometrial region was measured by a researcher

Secondary Outcome Measures

  1. Vascularization index of the endometrial region [Day 22 to 24 of the menstrual cycle]

    Vascularization index of the endometrial region was measured by a researcher

  2. Vascularization flow index of the endometrial region [Day 22 to 24 of the menstrual cycle]

    Vascularization flow index of the endometrial region was measured by a researcher

  3. Vascularization flow index of the sub-endometrial region [Day 22 to 24 of the menstrual cycle]

    Vascularization flow index of the sub-endometrial region was measured by a researcher

  4. Flow index of the sub-endometrial region [Day 22 to 24 of the menstrual cycle]

    Flow index of the sub-endometrial region was measured by a researcher

  5. Vascularization index of the sub-endometrial region [Day 22 to 24 of the menstrual cycle]

    Vascularization index of the sub-endometrial region was measured by a researcher

Eligibility Criteria

Criteria

Ages Eligible for Study:
25 Years to 35 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Obstetrics and Gynecology, Kasr Al-Ainy hospital, Cairo University Cairo Greater Cairo Egypt 11956

Sponsors and Collaborators

  • Cairo University

Investigators

  • Principal Investigator: Eman Omran, M.D., Cairo University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Eman Omran, principal investigator, Cairo University
ClinicalTrials.gov Identifier:
NCT03322852
Other Study ID Numbers:
  • 4588
First Posted:
Oct 26, 2017
Last Update Posted:
Oct 27, 2017
Last Verified:
Oct 1, 2017
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Infertility
Infertility, Female

Study Results

No Results Posted as of Oct 27, 2017