New Protocol in Unexplained Infertility | NCT04754243

Studies
New Protocol in Unexplained Infertility

NCT04754243

Sponsor

Tanta University

Status

Unknown status

Last Update Posted

Jul 18, 2023Actual

Enrollment

200Estimated

Phase

Phase 4

Conditions

Unexplained Infertility

Interventions

Gonadotropin
Standard protocol in IUI

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

Jul 2023

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

Mar 1, 2021Actual

Primary Completion Date

Dec 31, 2024Estimated

Completion Date

Dec 31, 2024Estimated

First Submitted Date

Feb 10, 2021

First Submission Date that Met QC Criteria

Feb 12, 2021

First Posted Date

Feb 15, 2021Actual

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

Jul 15, 2023

Last Update Posted Date

Jul 18, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

The new protocol ANTIUI provides good results regarding ovulation and pregnancy rates in patients with unexplained infertility

Detailed Description

Patients with unexplained infertility has normal investigations regarding hormonal, structural data. Semen is normal but no pregnancy occurs.

Before trying ICSI, we could help these patients with ANTIUI

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

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study group	Experimental	Will receive ANTIUI protocol	Drug: Gonadotropin
Control group	Active Comparator	Will receive standard protocol in IUI and unexplained infertility	Drug: Standard protocol in IUI

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Gonadotropin	Drug	Giving patients gonadotropins and antagonist cetrotide	Study group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Ovulation	Disappearance of mature follicle	6 months
Pregnancy	Number of pregnant cases	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Unexplained infertility
Duration less than 5 years
Good ovarian reserve AMH> 1.1
Normal patent tubes
No previous trials of IUI with the same protocol

Exclusion Criteria:

Age > 35 years
Duration of infertility> 5 years
Abnormal semen
Hypoplastic tubes
prior failed ICSI

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

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ayman Shehata Dawood	Recruiting	Tanta	Gharbia Governorate	31111	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Within 6 MONTHS

Types

Study Protocol

Time Frame

6 months

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D006062	Gonadotropins

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided