New Protocol in Unexplained Infertility

NCT ID: NCT04754243

Last Updated: 2023-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2024-12-31

Brief Summary

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

Detailed Description

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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

Conditions

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Unexplained Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

2 parallel groups each is receiving different intervention
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Study group

Will receive ANTIUI protocol

Group Type EXPERIMENTAL

Gonadotropin

Intervention Type DRUG

Giving patients gonadotropins and antagonist cetrotide

Control group

Will receive standard protocol in IUI and unexplained infertility

Group Type ACTIVE_COMPARATOR

Standard protocol in IUI

Intervention Type DRUG

Giving patients gonadotropins without antagonist cetrotide

Interventions

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Gonadotropin

Giving patients gonadotropins and antagonist cetrotide

Intervention Type DRUG

Standard protocol in IUI

Giving patients gonadotropins without antagonist cetrotide

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Tanta University

OTHER

Sponsor Role lead

Responsible Party

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Ayman S Dawood, MD

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ayman Shehata Dawood

Tanta, Gharbia Governorate, Egypt

Site Status RECRUITING

Countries

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Egypt

Facility Contacts

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Ayman Dawood, MD

Role: primary

+201020972067

Other Identifiers

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ANTIUI

Identifier Type: -

Identifier Source: org_study_id

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