Predictors of Success of IUI in Unexplained Infertility

Cairo University (CU)

Status: Completed

Conditions: Assisted Reproductive Techniques

Treatments: Device: Intrauterine insemenation

Study type: Interventional

Funder types: Other

Identifiers

NCT02787811

149

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Pregnant

Active Comparator group

Description:

women with positive serum beta HCG done 14 days after Intrauterine insemenation

Treatment:

Device: Intrauterine insemenation

Nonpregnant

Active Comparator group

Description:

women with negative serum beta HCG done 14 days after Intrauterine insemenation

Treatment:

Device: Intrauterine insemenation