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

Infertility, Female Clinical Trial

Official title:

Effect of Clomiphene Citrate on Uterine Hemodynamics in Women With Unexplained Infertility

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03322852
• Other study ID #: 4588
• Status: Completed
• Phase: N/A
• First received: October 24, 2017
• Last updated: October 26, 2017
• Start date: October 1, 2014
• Est. completion date: October 30, 2016

Study information

• Verified date: October 2017
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 30, 2016
• Est. primary completion date: October 1, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• Infertility, Female

Intervention

Other:
• Vascularization indices observation
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

Locations

Country	Name	City	State
Egypt	Department of Obstetrics and Gynecology, Kasr Al-Ainy hospital, Cairo University	Cairo	Greater Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Flow index of the endometrial region	Flow index of the endometrial region was measured by a researcher	Day 22 to 24 of the menstrual cycle
Secondary	Vascularization index of the endometrial region	Vascularization index of the endometrial region was measured by a researcher	Day 22 to 24 of the menstrual cycle
Secondary	Vascularization flow index of the endometrial region	Vascularization flow index of the endometrial region was measured by a researcher	Day 22 to 24 of the menstrual cycle
Secondary	Vascularization flow index of the sub-endometrial region	Vascularization flow index of the sub-endometrial region was measured by a researcher	Day 22 to 24 of the menstrual cycle
Secondary	Flow index of the sub-endometrial region	Flow index of the sub-endometrial region was measured by a researcher	Day 22 to 24 of the menstrual cycle
Secondary	Vascularization index of the sub-endometrial region	Vascularization index of the sub-endometrial region was measured by a researcher	Day 22 to 24 of the menstrual cycle