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

LUF - Luteinised Unruptured Follicle Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03580031
• Other study ID #: Ayman HCG
• Status: Completed
• Phase: Phase 4
• Start date: August 1, 2018
• Est. completion date: January 1, 2021

Study information

• Verified date: February 2022
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: January 1, 2021
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• Ordinary stimulated cycles

• IUI stimulated cycles

• Unruptured follicle after 10000 IU IM HCG triggering

Exclusion Criteria:

• IVF/ICSI cycles

Related Conditions & MeSH terms

• LUF - Luteinised Unruptured Follicle Syndrome

Intervention

Drug:
• hCG
A booster dose (10,000 IU of hCG) was given IM 48 hours after first triggering dose
• Saline Solution
2 ml of normal saline will be injected 48 hours after first triggering dose

Locations

Country	Name	City	State
Egypt	Ayman Shehata Dawood	Tanta	Algharbia

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ovulation rate	rupture of dominant follicle manifested by disappearance of follicle and presence of free fluid in douglas pouch	48 hours
Secondary	Pregnancy rate	Number of cases with positive serum pregnancy test	15 days