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New Protocol in Unexplained Infertility

Primary Purpose

Unexplained Infertility

Status

Recruiting

Phase

Phase 4

Locations

Egypt

Study Type

Interventional

Intervention

Gonadotropin

Standard protocol in IUI

About this trial

This is an interventional treatment trial for Unexplained Infertility

Eligibility Criteria

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

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

Sites / Locations

Ayman Shehata DawoodRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Study group

Control group

Arm Description

Will receive ANTIUI protocol

Will receive standard protocol in IUI and unexplained infertility

Outcomes

Primary Outcome Measures

Ovulation

Disappearance of mature follicle

Pregnancy

Number of pregnant cases

Secondary Outcome Measures

Full Information

NCT ID

NCT04754243

First Posted

February 10, 2021

Last Updated

July 15, 2023

Sponsor

Tanta University

1. Study Identification

Unique Protocol Identification Number

NCT04754243

Brief Title

New Protocol in Unexplained Infertility

Official Title

A Higher Ovulation and Pregnancy Rates in Patients With Unexplained Infertility After Application of ANTIUI Protocol: A Randomized Multicenter Controlled Study

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 1, 2021 (Actual)

Primary Completion Date

December 31, 2024 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Tanta University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Unexplained Infertility

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

2 parallel groups each is receiving different intervention

Masking

None (Open Label)

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Study group

Arm Type

Experimental

Arm Description

Will receive ANTIUI protocol

Arm Title

Control group

Arm Type

Active Comparator

Arm Description

Will receive standard protocol in IUI and unexplained infertility

Intervention Type

Drug

Intervention Name(s)

Gonadotropin

Intervention Description

Giving patients gonadotropins and antagonist cetrotide

Intervention Type

Drug

Intervention Name(s)

Standard protocol in IUI

Intervention Description

Giving patients gonadotropins without antagonist cetrotide

Primary Outcome Measure Information:

Title

Ovulation

Description

Disappearance of mature follicle

Time Frame

6 months

Title

Pregnancy

Description

Number of pregnant cases

Time Frame

6 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

Ayman Shehata Dawood

City

Tanta

State/Province

Gharbia

ZIP/Postal Code

31111

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ayman Dawood, MD

Phone

+201020972067

ayman.dawood@med.tanta.edu.eg

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Within 6 MONTHS

IPD Sharing Time Frame

6 months

Learn more about this trial

New Protocol in Unexplained Infertility

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