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Completed

NCT Number: NCT02787811

Predictors of Success of IUI in Unexplained Infertility

Superovulation will be conducted with 100 mg of oral clomiphene citrate (Clomifene; Young Poong Pharmaceutical, Incheon, Korea) for 5 days starting on day 3 of the menstrual cycle, followed by daily injection of 150 IU of human menopausal gonadotropin (hMG;Menogon; FerringPharamceutical Co, Germany). When more than 2 dominant follicles reached a diameter of 17 mm or the urinary specimen showed positive results for luteinizing hormone (LH) surge, 5000 IU of hCG (Pregnyl; Organon, Oss, the Netherlands) was injected intramuscularly.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

Superovulation will conducted with 100 mg of oral clomiphene citrate (Clomifene; Young Poong Pharmaceutical, Incheon, Korea) for 5 days starting on day 3 of the menstrual cycle, followed by daily injection of 150 IU of human menopausal gonadotropin (hMG;Menogon; FerringPharamceutical Co, Germany). When more than 2 dominant follicles reached a diameter of 17 mm or the urinary specimen showed positive results for luteinizing hormone (LH) surge, 5000 IU of hCG (Pregnyl; Organon, Oss, the Netherlands) was injected intramuscularly. Successful pregnancy after IUI was confirmed by ultrasound as one or more visible gestational sacs in the uterine cavity.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • These patients had at least 1 tube patent
  • there were no significant intrauterine or pelvic abnormalities demonstrated on pelvic-abdominal ultrasonography, hysteroscopy, and/or laparoscopy
  • serum follicular stimulating hormone (FSH) level of12 mIU/mL or less

Exclusion criteria

  • A woman's age of more than 40 years,
  • ovarian cyst detected in the ultrasound examination
  • uterine lesions such as submucosal leiomyoma, and a previous diagnosis of moderate to severe pelvic endometriosis.
  • women with body mass index > 35 kg/m2,
  • PCOS/anovulatory patients
  • signs of hyperandrogenemia

Treatment and study plan

Intrauterine insemenation

Device

Semen preparation processing hen intrauterine transfer after 24 hours of HCG triggering of ovulation

Primary outcomes

  1. chemical pregnancy rate

    Time frame: 14 days after IUI

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Factors Affecting Success of IUI in Women With Unexplained Infertility

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 1, 2016
Registry last updated
Mar 21, 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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