Booster Dose of HCG for Unruptured Follicle in Non IVF/ICSI Cycles

Booster Dose of Human Chorionic Gonadotrophin for Unruptured Follicle in Non IVF/ICSI Cycles: A Randomized Controlled Study

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

Study Overview

• Status: Completed
• Conditions: LUF - Luteinised Unruptured Follicle Syndrome
• Intervention / Treatment: Drug: hCG; Drug: Saline Solution

Detailed Description

In this study enrolled patients (n=160) who underwent controlled ovarian stimulation and timed intercourse with unruptured mature graffian follicle 48 hours after IM 10,000 IU HCG dose. Patients were allocated randomly into intervention group and control group. In the intervention group another booster dose (10,000 IU of hCG) was given IM while in the control group 2 ml normal saline was given IM leaving follicles for spontaneous rupture

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Algharbia
    • Tanta, Algharbia, Egypt, 31111
      • Ayman Shehata Dawood

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

• IVF/ICSI cycles

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study group; HCG IM 10,000 IU Im 48 hours after first triggering dose	Drug: hCG; A booster dose (10,000 IU of hCG) was given IM 48 hours after first triggering dose
Placebo Comparator: Control group; Saline 2m Injection im 48 hours after the first triggering dose	Drug: Saline Solution; 2 ml of normal saline will be injected 48 hours after first triggering dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ovulation rate	rupture of dominant follicle manifested by disappearance of follicle and presence of free fluid in douglas pouch	48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pregnancy rate	Number of cases with positive serum pregnancy test	15 days

Collaborators and Investigators

• Sponsor: Tanta University
• Investigators: Principal Investigator: Ayman Dawood, MD, Lecturer at Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2018
• Primary Completion (Actual): January 1, 2021
• Study Completion (Actual): January 1, 2021

Study Registration Dates

• First Submitted: June 26, 2018
• First Submitted That Met QC Criteria: June 26, 2018
• First Posted (Actual): July 9, 2018

Study Record Updates

• Last Update Posted (Actual): February 21, 2022
• Last Update Submitted That Met QC Criteria: February 3, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: pregnancy rate; Booster dose; HCG; LUF; Ovulation rate
• Other Study ID Numbers: Ayman HCG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: No individual participant data will be displayed

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes