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NCT04754243 Clinical Trial

New Protocol in Unexplained Infertility

Unexplained Infertility Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04754243
Other study ID # ANTIUI
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date March 1, 2021
Est. completion date December 31, 2024

Study information
Verified date July 2023
Source Tanta University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 35 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Gonadotropin
Giving patients gonadotropins and antagonist cetrotide
• Standard protocol in IUI
Giving patients gonadotropins without antagonist cetrotide

Locations
Country Name City State
Egypt Ayman Shehata Dawood Tanta Gharbia

Sponsors (1)
Lead Sponsor Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Ovulation Disappearance of mature follicle 6 months
Primary Pregnancy Number of pregnant cases 6 months
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