Timing and Intrauterine Insemination in Unexplained Infertility

April 17, 2019 updated by: Salwa Sabry Ahmed Mohamed, Sohag University

Different Timing of Intrauterine Insemination and Pregnancy Outcome in Patient With Unexplained Infertility :A Randomized Controlled Study

to determine the most suitable time for administration of (human chorionic gonadotropin )hCG prior to intrauterine insemination (IUI) to optimize pregnancy outcome and to have the best success rates so the cases divided in to four groups according to the time of hCG administration .

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

IUI with or without ovarian stimulation is a common treatment for infertility ,it is a simple procedure the semen is prepared in the laboratory and transferred by a catheter and injected intrauterine .ultrasound folliculometry is used for monitoring follicular growth where some clinicians prefer the natural cycles and others prefer ovarian stimulation and human chorionic gonadotropin (hCG)trigger for better timing .so cases will take induction and folliculometry will be done until the follicle reach 18mm trigger with hCG .women will be randomly divided to four groups .the first group will undergo IUI at 24 after trigger the second IUI at36 hour after trigger the thirdG at 48 after trigger and finaly the last group IUI will be done simultaneos with trigger the out come the number of pregnant women for each group.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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:

  • Mild male infertility or unexplained infertility

Exclusion Criteria:

  • Adanced male factor endometriosis uterine abnormality sever semen parameters i impairment according to WHO 2010 non ovulatory cycles bilatral tubal block

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: GROUP 1
IUI 24 hours after hCGadminstration
Drug: hCG
Women will be given hCG before or with IUI
Other Names:
  • Pregnyl
Active Comparator: GROUP 2
IUI 36 hours after hCG adminstration
Drug: hCG
Women will be given hCG before or with IUI
Other Names:
  • Pregnyl
Active Comparator: GROUP 3
IUI 48 hours after hCG adminstration
Drug: hCG
Women will be given hCG before or with IUI
Other Names:
  • Pregnyl
Active Comparator: GROUP 4
IUI at time of hCG adminstration
Drug: hCG
Women will be given hCG before or with IUI
Other Names:
  • Pregnyl

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary outcome
Time Frame: 14 days after IUI
Positive serum beta hCG test
14 days after IUI
Secondary outcome
Time Frame: 4 weeks after insemination
Clinical pregnancy defined as prescence of at least one Intrauterine gestational sac with fetal pole on Transvaginal scan
4 weeks after insemination

Collaborators and Investigators

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

Sponsor

Sohag University

Investigators

  • Principal Investigator: Allam Mohamed Abd elmonam, Professor of obs and gyn, Faculty of medicine sohag university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Anticipated)

April 30, 2019

Primary Completion (Anticipated)

September 30, 2019

Study Completion (Anticipated)

December 31, 2019

Study Registration Dates

First Submitted

April 16, 2019

First Submitted That Met QC Criteria

April 17, 2019

First Posted (Actual)

April 19, 2019

Study Record Updates

Last Update Posted (Actual)

April 19, 2019

Last Update Submitted That Met QC Criteria

April 17, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Intrauterine insemination

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Intrauterine Insemination

Clinical Trials on hCG

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Angola

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe