Effect of Local Endometrial Injury on Pregnancy Outcomes... | NCT02345837

Studies
Effect of Local Endometrial Injury on Pregnancy Outcomes During Ovulation Induction Cycles

NCT02345837

Sponsor

Al Hayat National Hospital

Status

Unknown status

Last Update Posted

Apr 6, 2016Estimated

Enrollment

160Estimated

Phase

Not Applicable

Conditions

Asymptomatic Diseases

Interventions

endometrial sampling
clomiphene citrate

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

Apr 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2014

Primary Completion Date

Sep 2016Estimated

Completion Date

Sep 2016Estimated

First Submitted Date

Jan 20, 2015

First Submission Date that Met QC Criteria

Jan 20, 2015

First Posted Date

Jan 26, 2015Estimated

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

Apr 4, 2016

Last Update Posted Date

Apr 6, 2016Estimated

Name	Class
Menoufia University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

The aim of this study is to detect whether or not performing an endometrial sampling in the cycle preceding ovulation induction with clomiphene citrate can improve pregnancy outcomes in the next cycle.

Detailed Description

Patients will be randomized using a list of computer generated random sample into two groups:

Group 1: Couples who will undergo endometrial sampling in the luteal phase of the cycle preceding ovulation induction by clomiphene citrate.

Group 2: Couples who will undergo ovulation induction with clomiphene citrate. The drug chosen for ovulation induction in both groups will be clomephine citrate.

Timing and technique of endometrial sampling:

Timing: from day 15 to day 24 of the cycle preceding ovulation induction cycle. Technique: this will be done using the pipelle method (Williams et al., 2008).

The procedure is as follows:

Vaginal speculum to expose the uterine cervix then sterilization by saline.
The piston positioned at the extreme distal end of the sheath then the Pipelle is inserted gently through the cervical canal into the cavity of the uterus.
While holding the sheath in position with one hand, the other hand rapidly pulls the piston firmly and without interruption.
A negative pressure within the sheath will draw the tissue into the curette opening at the distal end of the sheath and captures the separated tissue within its lumen.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

160Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
clomiphene and endometrial sampling	Active Comparator	Couples who will undergo endometrial sampling in the luteal phase of the cycle preceding ovulation induction by clomiphene citrate.	Device: endometrial sampling Drug: clomiphene citrate
clomiphene citrate	Active Comparator	Couples who will undergo ovulation induction with clomiphene citrate.	Drug: clomiphene citrate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
endometrial sampling	Device	injury to the endometrium	clomiphene and endometrial sampling

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinical pregnancy rate.		one year
Miscarriage rate.		one year
Multiple pregnancy rates		one year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male partner should have a normal semen count and motility according to world health organization criteria (Murray et al., 2012).
Primary, secondary or unexplained infertility for at least one year.
Failure to conceive with clomiphene citrate in spite of good follicular response for at least 3 cycles.
Age varies from 20-35 years with at least one year of infertility.
Body mass index between 19-30 kg/m2.
Day 2 serum FSH< 12 IU/ml.
Normal uterine cavity on hystrosalpingography.
At least one patent tube of normal appearance on HSG.
No previous attempts of intrauterine insemination (IUI) or in vitro fertilization (IVF).

Exclusion Criteria:

Infertility due to tubal factor or male factor.
Intrauterine organic pathology (myoma, polyp, adhesions) by hystrosalpingogram or diagnostic hysteroscope.
Hypogonadotrophic hypogonadism.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
mohamed maher	Contact	+966558198655		mohamaher2015@gmail.com

Overall Officials

Name	Affiliation	Role
menoufia university	menoufia fuculty of medicine	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Menoufia University	Recruiting	Shebin Elkom			Egypt

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28397981	Derived	Helmy MEE, Maher MA, Elkhouly NI, Ramzy M. A randomized trial of local endometrial injury during ovulation induction cycles. Int J Gynaecol Obstet. 2017 Jul;138(1):47-52. doi: 10.1002/ijgo.12178. Epub 2017 May 4.

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D013267	Stilbenes
D001597	Benzylidene Compounds
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic