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Completed

NCT Number: NCT02349750

Endometrial Scratch Injury in Women With Unexplained Infertility Undergoing IUI

The study included 154 infertile women Patients received 100 mg of oral clomiphene citrate for five days starting on day 3 of the menstrual cycle, followed by daily injection of 150 IU of hMG and when more than two dominant follicles reached a diameter of 17 mm 5,000 IU of hCG was injected intramuscularly. Patients were randomly allocated into two equal groups: Group C received IUI without ESI and Group S had ESI using No.8 neonatal feeding tube and after 24 to 36 hours, IUI was performed. Successful pregnancy was con-firmed by ultrasound and patients had failed trial underwent another trial of IUI for a maximum of three trials.

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Key information

Conditions

Unexplained Infertility

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

The study included 154 infertile women with mean duration of infertility of 3.9±0.4 years. Patients received 100 mg of oral clomiphene citrate for five days starting on day 3 of the menstrual cycle, followed by daily injection of 150 IU of hMG and when more than two dominant follicles reached a diameter of 17 mm 5,000 IU of hCG was injected intramuscularly. Patients were randomly allocated into two equal groups: Group C received IUI without ESI and Group S had ESI using No.8 neonatal feeding tube and after 24 to 36 hours, IUI was performed. Successful pregnancy was con-firmed by ultrasound and patients had failed trial underwent another trial of IUI for a maximum of three trials.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Couple with unexplained infertility and assigned for IUI

Exclusion criteria

  • Woman's age of more than 40 years
  • Ovarian cyst detected in the ultrasound examination
  • Uterine lesions such as submucosal leiomyoma
  • A previous diagnosis of moderate to severe pelvic endometriosis
  • Women with body mass index ≥35 kg/m2 o
  • Women with signs of hyperandrogenemia dy

Treatment and study plan

endometrial scratch injury

Procedure

ESI using No.8 neonatal feeding tube

Primary outcomes

  1. clinical pregnancy

    Time frame: 14 days after IUI

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Endometrial Scratch Injury Induced Higher Pregnancy Rate for Women With Unexplained Infertility Undergoing IUI With Ovarian Stimulation

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Jan 29, 2015
Registry last updated
Jan 29, 2015

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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