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Predictors of Success of IUI in Unexplained Infertility

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ClinicalTrials.gov Identifier: NCT02787811
Recruitment Status : Completed
First Posted : June 1, 2016
Last Update Posted : March 21, 2017
Sponsor:
Information provided by (Responsible Party):
Ahmed Maged, Cairo University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Assisted Reproductive Techniques Device: Intrauterine insemenation Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Factors Affecting Success of IUI in Women With Unexplained Infertility
Actual Study Start Date : May 2016
Actual Primary Completion Date : February 2017
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility

Arm Intervention/treatment
Active Comparator: Pregnant
women with positive serum beta HCG done 14 days after Intrauterine insemenation
Device: Intrauterine insemenation
Semen preparation processing hen intrauterine transfer after 24 hours of HCG triggering of ovulation

Active Comparator: Nonpregnant
women with negative serum beta HCG done 14 days after Intrauterine insemenation
Device: Intrauterine insemenation
Semen preparation processing hen intrauterine transfer after 24 hours of HCG triggering of ovulation




Primary Outcome Measures :
  1. chemical pregnancy rate [ Time Frame: 14 days after IUI ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02787811


Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: Ahmed Maged, MD Cairo University
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Responsible Party: Ahmed Maged, Assistant professor, Cairo University
ClinicalTrials.gov Identifier: NCT02787811    
Other Study ID Numbers: 149
First Posted: June 1, 2016    Key Record Dates
Last Update Posted: March 21, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Ahmed Maged, Cairo University:
IUI
Pregnancy rate
predictors
Additional relevant MeSH terms:
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Infertility