NCT04754243

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2021

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 10, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 15, 2021

Completed
14 days until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

July 18, 2023

Status Verified

July 1, 2023

Enrollment Period

3.8 years

First QC Date

February 10, 2021

Last Update Submit

July 15, 2023

Conditions

Unexplained Infertility

Outcome Measures

Primary Outcomes (2)

  • Ovulation

    Disappearance of mature follicle

    6 months

  • Pregnancy

    Number of pregnant cases

    6 months

Study Arms (2)

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

GonadotropinDRUG

Giving patients gonadotropins and antagonist cetrotide

Study group
Standard protocol in IUIDRUG

Giving patients gonadotropins without antagonist cetrotide

Control group

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ayman Shehata Dawood

Tanta, Gharbia Governorate, 31111, Egypt

RECRUITING

MeSH Terms

Interventions

Gonadotropins

Intervention Hierarchy (Ancestors)

Peptide HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 2 parallel groups each is receiving different intervention
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

February 10, 2021

First Posted

February 15, 2021

Study Start

March 1, 2021

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

July 18, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will share

Within 6 MONTHS

Shared Documents
STUDY PROTOCOL
Time Frame
6 months

Locations

EG(1)