Effect of Laparoscopic Ovarian Drilling on Outcomes of in... | NCT03527979

Studies
Effect of Laparoscopic Ovarian Drilling on Outcomes of in Vitro Fertilisation in Clomiphene-resistant Women With Polycystic Ovary Syndrome

NCT03527979

Sponsor

Ain Shams University

Status

Unknown status

Last Update Posted

May 17, 2018Actual

Enrollment

88Actual

Phase

Not Applicable

Conditions

PCOS

Interventions

IVF/ICSI

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

May 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2018Actual

Primary Completion Date

Aug 2018Estimated

Completion Date

Sep 2018Estimated

First Submitted Date

Apr 19, 2018

First Submission Date that Met QC Criteria

May 6, 2018

First Posted Date

May 17, 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

May 6, 2018

Last Update Posted Date

May 17, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

the polycystic ovarian syndrome is associated with an ovulation and infertility. recently the laparoscopic ovarian drilling has been used as surgical treatment for ovulation in women with polycystic ovarian syndrome, although its mechanism and outcomes are still unclear. this study is undertaken to evaluate the in vitro fertilisation outcomes in clomiphene-resistant women with PCOS who were treated with LOD.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

88Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PCOS women with history of LOD before IVF/ICSI	Active Comparator		Procedure: IVF/ICSI
PCOS women without history of drilling	Active Comparator		Procedure: IVF/ICSI

Interventions

Name	Type	Description	Arm Group Labels	Other Names
IVF/ICSI	Procedure	IVF/ICSI	PCOS women with history of LOD before IVF/ICSI PCOS women without history of drilling

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
clinical pregnancy rate confirmed by b-hcg and visualizations of gestational sac by ultrasound	Pregnancy confirmed by b-hcg and visualization of gestational sac by ultrasound	3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age between 25 and 35
patients with established PCOS
history at least one year infertility
no response to clomiphene citrate for at least three cycles

Exclusion Criteria:

history of previous IVF/ICSI
chronic disease such as thyroid disorder and DM
infertility due to sever male factor
sever endometriosis
infertility due to uterine factor such as multiple fibroid
body mass index > 30

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ain Shams university		Cairo			Egypt