Predictors of Success of IUI in Unexplained Infertility

Not Applicable

Completed

• Conditions: Assisted Reproductive Techniques
• Interventions: Device: Intrauterine insemenation

• Registration Number: NCT02787811
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-05-23
• Study First Submitted QC: 2016-05-26
• Study First Posted: 2016-06-01
• Primary Completion: 2017-02
• Study Completion: 2017-02
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-18
• Last Update Posted: 2017-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nonpregnant	Intrauterine insemenation	women with negative serum beta HCG done 14 days after Intrauterine insemenation
Pregnant	Intrauterine insemenation	women with positive serum beta HCG done 14 days after Intrauterine insemenation

Primary Outcome Measures

Name	Time	Method
chemical pregnancy rate	14 days after IUI