NCT03580031

Brief Summary

This study will be conducted to assess the effect of booster dose of hCG on the unruptured follicles in non IVF/ICSI cycles.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Aug 2018

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

June 26, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 9, 2018

Completed
23 days until next milestone

Study Start

First participant enrolled

August 1, 2018

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

February 21, 2022

Status Verified

February 1, 2022

Enrollment Period

2.4 years

First QC Date

June 26, 2018

Last Update Submit

February 3, 2022

Conditions

LUF - Luteinised Unruptured Follicle Syndrome

Keywords

LUFHCGBooster doseOvulation ratepregnancy rate

Outcome Measures

Primary Outcomes (1)

  • Ovulation rate

    rupture of dominant follicle manifested by disappearance of follicle and presence of free fluid in douglas pouch

    48 hours

Secondary Outcomes (1)

  • Pregnancy rate

    15 days

Study Arms (2)

Study group

EXPERIMENTAL

HCG IM 10,000 IU Im 48 hours after first triggering dose

Drug: hCG

Control group

PLACEBO COMPARATOR

Saline 2m Injection im 48 hours after the first triggering dose

Drug: Saline Solution

Interventions

hCGDRUG

A booster dose (10,000 IU of hCG) was given IM 48 hours after first triggering dose

Study group
Saline SolutionDRUG

2 ml of normal saline will be injected 48 hours after first triggering dose

Control group

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Ordinary stimulated cycles
  • IUI stimulated cycles
  • Unruptured follicle after 10000 IU IM HCG triggering

You may not qualify if:

  • IVF/ICSI cycles

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ayman Shehata Dawood

Tanta, Algharbia, 31111, Egypt

Location

MeSH Terms

Interventions

Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Ayman Dawood, MD

    Lecturer at Tanta University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Double blinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Cohort groups with parallel allocation
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

June 26, 2018

First Posted

July 9, 2018

Study Start

August 1, 2018

Primary Completion

January 1, 2021

Study Completion

January 1, 2021

Last Updated

February 21, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

No individual participant data will be displayed

Locations

EG(1)