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Predictors of Success of IUI in Unexplained Infertility

Primary Purpose

Assisted Reproductive Techniques

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Intrauterine insemenation

About this trial

This is an interventional diagnostic trial for Assisted Reproductive Techniques focused on measuring IUI, Pregnancy rate, predictors

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Pregnant

Nonpregnant

Arm Description

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

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

Outcomes

Primary Outcome Measures

chemical pregnancy rate

Secondary Outcome Measures

Full Information

NCT ID

NCT02787811

First Posted

May 23, 2016

Last Updated

March 18, 2017

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT02787811

Brief Title

Predictors of Success of IUI in Unexplained Infertility

Official Title

Factors Affecting Success of IUI in Women With Unexplained Infertility

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Completed

Study Start Date

May 2016 (Actual)

Primary Completion Date

February 2017 (Actual)

Study Completion Date

February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Assisted Reproductive Techniques

Keywords

IUI, Pregnancy rate, predictors

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Pregnant

Arm Type

Active Comparator

Arm Description

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

Arm Title

Nonpregnant

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Intrauterine insemenation

Intervention Description

Semen preparation processing hen intrauterine transfer after 24 hours of HCG triggering of ovulation

Primary Outcome Measure Information:

Title

chemical pregnancy rate

Time Frame

14 days after IUI

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ahmed Maged, MD

Organizational Affiliation

Cairo University

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

Predictors of Success of IUI in Unexplained Infertility

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