CClinicalTrials.gg
CompletedNCT03322852Updated Oct 27, 2017

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

An observational study in Infertility, Female, sponsored by Cairo University. Completed at 1 site in Egypt. Open to female participants aged 25 Years to 35 Years. Per ClinicalTrials.gov, last updated 2017-10-27.

Sponsored by Cairo University · Observational

Study type
Observational
Model
Case-crossover
Time perspective
Prospective
Enrollment
50
Ages
25 Years to 35 Years
Sex
Female
01

Study 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 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.

02

Conditions studied

  • Infertility, Female
03

Who can participate

Ages eligible
25 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients who had unexplained infertility

Inclusion criteria

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

Exclusion criteria

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
04

Study design

Observational model
Case-crossover
Time perspective
Prospective
Enrollment
50 participants (actual)
Patient registry
No

Interventions

  • OtherVascularization 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

05

What researchers measure

Primary outcomes

  1. Flow index of the endometrial region

    Flow index of the endometrial region was measured by a researcher

    Time frame: Day 22 to 24 of the menstrual cycle

Secondary outcomes

  1. Vascularization index of the endometrial region

    Vascularization index of the endometrial region was measured by a researcher

    Time frame: Day 22 to 24 of the menstrual cycle

  2. Vascularization flow index of the endometrial region

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

    Time frame: Day 22 to 24 of the menstrual cycle

  3. Vascularization flow index of the sub-endometrial region

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

    Time frame: Day 22 to 24 of the menstrual cycle

  4. Flow index of the sub-endometrial region

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

    Time frame: Day 22 to 24 of the menstrual cycle

  5. Vascularization index of the sub-endometrial region

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

    Time frame: Day 22 to 24 of the menstrual cycle

06

Study locations

1 site
  • Department of Obstetrics and Gynecology, Kasr Al-Ainy hospital, Cairo University
    Cairo, Greater Cairo 11956, Egypt
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03322852
Lead sponsor
Cairo University
Responsible party
Eman Omran (principal investigator, Cairo University) — Principal investigator
First posted
Oct 26, 2017
Start date
Oct 1, 2014
Primary completion
Oct 1, 2016
Completion
Oct 30, 2016
Last update
Oct 27, 2017

Study contacts

Eman Omran, M.D.
principal investigator · Cairo University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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