a Predictive Scheme for Poor Responders in IVF Cycles | NCT02351193

Studies
a Predictive Scheme for Poor Responders in IVF Cycles

NCT02351193

Sponsor

Dina Mohamed Refaat Dakhly

Status

Completed

Last Update Posted

Feb 2, 2015Estimated

Enrollment

928Actual

Phase

Not provided

Conditions

Infertility

Interventions

transvaginal Ultrasound

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

Jan 2015

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

Jan 2011

Primary Completion Date

Dec 2013Actual

Completion Date

Dec 2013Actual

First Submitted Date

Jan 26, 2015

First Submission Date that Met QC Criteria

Jan 29, 2015

First Posted Date

Jan 30, 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

Jan 30, 2015

Last Update Posted Date

Feb 2, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dina Mohamed Refaat Dakhly, Lecturer of Obstetrics and Gynecology, Woman's Health University Hospital, EgyptSponsor-Investigator

Lead Sponsor

Dina Mohamed Refaat DakhlyOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

While practicing the different assisted reproductive techniques, the investigators are faced daily by the problem of poor responder females, and the debate about predicting its results based on the outcome of the different ORTs used. Due to the cost of AMH as an indicator for ovarian response, the need to re-assess its role was essential in our community, which led us to conduct this prospective multi-center IVF study.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

928Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group I		poor responder females with age less than 35	Other: transvaginal Ultrasound
Group II		poor responder females with age more than 35	Other: transvaginal Ultrasound

Interventions

Name	Type	Description	Arm Group Labels	Other Names
transvaginal Ultrasound	Other		Group I Group II

Measure	Description	Time Frame
Number of MII oocytes		2 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

normal body mass index (BMI)
AMH from 0.5-1.1 ng/ml.
previous history of ≤3 oocytes retrieved using conventional long stimulation protocol

Exclusion Criteria:

Females suffering from other causes of infertility as tubal, uterine factors or known cases of endometriosis
severe cases of male factor as azospermia
females who were unable or not willing to participate in the study were excluded from the study.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Poor responder females

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dina MR Dakhly, MD	Cairo University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kasr el aini hospital		Cairo	Cairo Governorate		Egypt

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