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Timing of HCG Administration in IUI Cycles

Primary Purpose

Infertility

Status
Unknown status
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
HCG
Sponsored by
Mohamed Ibrahem Eid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Infertility focused on measuring Intrauterine insemination, IUI, HCG

Eligibility Criteria

20 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Fertility care unit (FCU) in Mansoura University HospitalsRecruiting
  • Private fertility care centersRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Group A

Group B

Group C

Arm Description

IUI at time of HCG

IUI 12 hours after HCG

IUI 34-36 hours after HCG

Outcomes

Primary Outcome Measures

Clinical pregnancy rate
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

Secondary Outcome Measures

Full Information

First Posted
December 31, 2014
Last Updated
January 24, 2019
Sponsor
Mohamed Ibrahem Eid
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1. Study Identification

Unique Protocol Identification Number
NCT02330705
Brief Title
Timing of HCG Administration in IUI Cycles
Official Title
Timing of Human Chorionic Gonadotropin Administration in Intrauterine Insemination Cycles
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
July 2019 (Anticipated)
Study Completion Date
August 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mohamed Ibrahem Eid

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
Intrauterine insemination, IUI, HCG

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
225 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Active Comparator
Arm Description
IUI at time of HCG
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
IUI 12 hours after HCG
Arm Title
Group C
Arm Type
Active Comparator
Arm Description
IUI 34-36 hours after HCG
Intervention Type
Drug
Intervention Name(s)
HCG
Other Intervention Name(s)
Pregnyl
Intervention Description
Women will be given HCG before IUI
Primary Outcome Measure Information:
Title
Clinical pregnancy rate
Description
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
Time Frame
4-6 weeks after IUI

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed I Eid, Dr
Phone
+201225401274
Email
dr_moh_eid@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed I Eid, Dr
Organizational Affiliation
Mansoura University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fertility care unit (FCU) in Mansoura University Hospitals
City
Mansourah
State/Province
Dakahlia
ZIP/Postal Code
35111
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed I Eid, Dr
Phone
+201225401274
Email
dr_moh_eid@yahoo.com
Facility Name
Private fertility care centers
City
Mansourah
State/Province
Dakahlia
Country
Egypt
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Timing of HCG Administration in IUI Cycles

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