Predictors of Success of IUI in Unexplained Infertility

Assisted Reproductive Techniques Clinical Trial

Official title:

Factors Affecting Success of IUI in Women With Unexplained Infertility

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02787811
• Other study ID #: 149
• Status: Completed
• Phase: N/A
• First received: May 23, 2016
• Last updated: March 18, 2017
• Start date: May 2016
• Est. completion date: February 2017

Study information

• Verified date: March 2017
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Assisted Reproductive Techniques
• Infertility

Intervention

Device:
• Intrauterine insemenation
Semen preparation processing hen intrauterine transfer after 24 hours of HCG triggering of ovulation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	chemical pregnancy rate		14 days after IUI