Induction of Ovulation Using Clomiphene Citrate and N-ace... | NCT03241472

Studies
Induction of Ovulation Using Clomiphene Citrate and N-acetyl Cysteine Versus Letrozole

NCT03241472

Sponsor

Assiut University

Status

Completed

Last Update Posted

Aug 7, 2017Actual

Enrollment

100Actual

Phase

Phase 3

Conditions

Infertility

Interventions

Letrozole
Clomiphene Citrate plus N acetyl cystine

Countries

Not provided

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

Aug 2017

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

Feb 2016Actual

Primary Completion Date

May 2017Actual

Completion Date

Jun 2017Actual

First Submitted Date

Aug 3, 2017

First Submission Date that Met QC Criteria

Aug 3, 2017

First Posted Date

Aug 7, 2017Actual

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

Aug 3, 2017

Last Update Posted Date

Aug 7, 2017Actual

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Infertility is defined as a couple's inability to become pregnant after one year of unprotected intercourse in women 35 years old and younger, and for six months in women over age 35 years. In any given year, about 15 percent of couples in North America and Europe who are trying to conceive are infertile

Detailed Description

Not provided

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lertozole	Experimental	oral tablets 5 mg start from third day cycle for 5 days	Drug: Letrozole
clomiphene plus N- acetyl cystiene	Active Comparator	clomiphene 100 mg plus N-acetyl cystiene 600 mg start from third day cycle for 5 days	Drug: Clomiphene Citrate plus N acetyl cystine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Letrozole	Drug	oral tablets 5 mg	Lertozole
Clomiphene Citrate plus N acetyl cystine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
rate of ovulation	ultrasound evaluation	3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All primary and secondary. Infertility due to anovulation

Exclusion Criteria:

Male factor infertility, tubal factor.
Endocrineopathy
Hypothyrodism
Morbid obesity
Under weight
Patient with previous surgery including drilling of ovary, Clomiphene Citrate resistant to ovulation.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007246	Infertility

Ancestor Terms

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077289	Letrozole
D002996	Clomiphene

Ancestor Terms

ID	Term
D009570	Nitriles
D009930	Organic Chemicals
D014230	Triazoles
D001393	Azoles
D006573

Browse Leaves

Not provided

Browse Branches

Not provided