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Completed

NCT Number: NCT03322852

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

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.

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Key information

Conditions

Infertility, Female Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infertility Urogenital Diseases

Age range

25 year–35 year

Sex eligibility

Female

Study type

Observational

Primary location

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

Cairo, Greater Cairo, 11956, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vascularization indices observation

Other

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Vascularization index of the endometrial region

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: Day 22 to 24 of the menstrual cycle

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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Oct 26, 2017
Registry last updated
Oct 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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