Timing of HCG Administration in IUI Cycles | NCT02330705

Studies
Timing of HCG Administration in IUI Cycles

NCT02330705

Sponsor

Mohamed Ibrahem Eid

Status

Unknown status

Last Update Posted

Jan 25, 2019Actual

Enrollment

225Estimated

Phase

Phase 4

Conditions

Infertility

Interventions

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2015

Primary Completion Date

Jul 2019Estimated

Completion Date

Aug 2019Estimated

First Submitted Date

Dec 31, 2014

First Submission Date that Met QC Criteria

Jan 1, 2015

First Posted Date

Jan 5, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 24, 2019

Last Update Posted Date

Jan 25, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

225Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A	Active Comparator	IUI at time of HCG	Drug: HCG
Group B	Active Comparator	IUI 12 hours after HCG	Drug: HCG
Group C	Active Comparator	IUI 34-36 hours after HCG	Drug: HCG

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HCG	Drug	Women will be given HCG before IUI	Group A Group B Group C

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	4-6 weeks after IUI

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mohamed I Eid, Dr	Contact	+201225401274		dr_moh_eid@yahoo.com

Overall Officials

Name	Affiliation	Role
Mohamed I Eid, Dr	Mansoura University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fertility care unit (FCU) in Mansoura University Hospitals	Recruiting	Al Mansurah	Dakahlia Governorate	35111	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007246	Infertility

Ancestor Terms

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D006063	Chorionic Gonadotropin

Ancestor Terms

ID	Term
D006062	Gonadotropins
D036361	Peptide Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists

Browse Leaves

Not provided

Browse Branches

Not provided