Predictors of Success of IUI in Unexplained Infertility

March 18, 2017 updated by: Ahmed Maged, Cairo University

Factors Affecting Success of IUI in Women With 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
chemical pregnancy rate
Time Frame: 14 days after IUI
14 days after IUI

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2016

Primary Completion (Actual)

February 1, 2017

Study Completion (Actual)

February 1, 2017

Study Registration Dates

First Submitted

May 23, 2016

First Submitted That Met QC Criteria

May 26, 2016

First Posted (Estimate)

June 1, 2016

Study Record Updates

Last Update Posted (Actual)

March 21, 2017

Last Update Submitted That Met QC Criteria

March 18, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 149

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe