NCT03322852

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2016

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

October 24, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 26, 2017

Completed
Last Updated

October 27, 2017

Status Verified

October 1, 2017

Enrollment Period

2 years

First QC Date

October 24, 2017

Last Update Submit

October 26, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Vascularization index of the endometrial region

    Day 22 to 24 of the menstrual cycle

  • Vascularization flow index of the endometrial region

    Day 22 to 24 of the menstrual cycle

  • Vascularization flow index of the sub-endometrial region

    Day 22 to 24 of the menstrual cycle

  • Flow index of the sub-endometrial region

    Day 22 to 24 of the menstrual cycle

  • Vascularization index of the sub-endometrial region

    Day 22 to 24 of the menstrual cycle

Interventions

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

Eligibility Criteria

Age25 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients who had unexplained infertility

You may qualify if:

  • Unexplained infertility
  • Body mass index less than 30
  • Regular menstruation
  • Normal pelvic examination and ultrasonography

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Obstetrics and Gynecology, Kasr Al-Ainy hospital, Cairo University

Cairo, Greater Cairo, 11956, Egypt

Location

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesInfertility

Study Officials

  • Eman Omran, M.D.

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

October 24, 2017

First Posted

October 26, 2017

Study Start

October 1, 2014

Primary Completion

October 1, 2016

Study Completion

October 30, 2016

Last Updated

October 27, 2017

Record last verified: 2017-10

Locations