Timing of HCG Administration in IUI Cycles

January 24, 2019 updated by: Mohamed Ibrahem Eid

Timing of Human Chorionic Gonadotropin Administration in Intrauterine Insemination Cycles

Evaluation of the effect of altering the timing of human chorionic gonadotropin (HCG) administration on the clinical pregnancy rate in intrauterine insemination (IUI) cycles.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Women will be randomly divided into 3 groups; the first group will undergo IUI at the time HCG administration, the second group will undergo IUI 12 hours after HCG administration and the third group will undergo IUI 34-36 hours after HCG administration.

Study Type

Interventional

Enrollment (Anticipated)

225

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.

Study Locations

  • Egypt
    • Dakahlia
      • Mansourah, Dakahlia, Egypt, 35111
        • Recruiting
        • Fertility care unit (FCU) in Mansoura University Hospitals
        • Contact:
      • Mansourah, Dakahlia, Egypt
        • Recruiting
        • Private fertility care centers

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

20 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Mild male factor infertility or unexplained infertility.

Exclusion Criteria:

  • Advanced male factor infertility.
  • Polycystic ovary syndrome (PCOS) as defined by the Rotterdam criteria.
  • Endometriosis.
  • Tubal disease.
  • Uterine abnormalities or myoma.
  • Previous uterine surgery.
  • Metabolic or hormonal abnormalities.

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A
IUI at time of HCG
Drug: HCG
Women will be given HCG before IUI
Other Names:
  • Pregnyl
Active Comparator: Group B
IUI 12 hours after HCG
Drug: HCG
Women will be given HCG before IUI
Other Names:
  • Pregnyl
Active Comparator: Group C
IUI 34-36 hours after HCG
Drug: HCG
Women will be given HCG before IUI
Other Names:
  • Pregnyl

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical pregnancy rate
Time Frame: 4-6 weeks after IUI
Number of clinical pregnancies (defined as presence of at least one intrauterine gestational sac with fetal pole and cardiac activity on TVS scan at 4-6 weeks after IUI) divided by the number of IUI cycles
4-6 weeks after IUI

Collaborators and Investigators

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

Sponsor

Mohamed Ibrahem Eid

Investigators

  • Principal Investigator: Mohamed I Eid, Dr, Mansoura 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

January 1, 2015

Primary Completion (Anticipated)

July 1, 2019

Study Completion (Anticipated)

August 1, 2019

Study Registration Dates

First Submitted

December 31, 2014

First Submitted That Met QC Criteria

January 1, 2015

First Posted (Estimate)

January 5, 2015

Study Record Updates

Last Update Posted (Actual)

January 25, 2019

Last Update Submitted That Met QC Criteria

January 24, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MIE3

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.

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