Booster Dose of HCG for Unruptured Follicle in Non IVF/IC... | NCT03580031

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

NCT03580031

Sponsor

Tanta University

Status

Completed

Last Update Posted

Feb 21, 2022Actual

Enrollment

110Actual

Phase

Phase 4

Conditions

LUF - Luteinised Unruptured Follicle Syndrome

Interventions

hCG
Saline Solution

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2018Actual

Primary Completion Date

Jan 1, 2021Actual

Completion Date

Jan 1, 2021Actual

First Submitted Date

Jun 26, 2018

First Submission Date that Met QC Criteria

Jun 26, 2018

First Posted Date

Jul 9, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 3, 2022

Last Update Posted Date

Feb 21, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

110Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
hCG	Drug	A booster dose (10,000 IU of hCG) was given IM 48 hours after first triggering dose	Study group

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

IVF/ICSI cycles

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ayman Dawood, MD	Lecturer at Tanta University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ayman Shehata Dawood		Tanta	Algharbia	31111	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

No individual participant data will be displayed

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077330	Saline Solution

Ancestor Terms

ID	Term
D000077324	Crystalloid Solutions
D007552	Isotonic Solutions
D012996	Solutions
D004364	Pharmaceutical Preparations

Browse Leaves

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Browse Branches

Not provided