Factors Associated With Pregnancy Loss in IVF Women | NCT02383394

Studies
Factors Associated With Pregnancy Loss in IVF Women

NCT02383394

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

Apr 5, 2017Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Invitro Fertilization

Interventions

follow up antenatal care

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 2017

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

Apr 2015Actual

Primary Completion Date

May 2017Estimated

Completion Date

Aug 2017Estimated

First Submitted Date

Mar 4, 2015

First Submission Date that Met QC Criteria

Mar 6, 2015

First Posted Date

Mar 9, 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, 2017

Last Update Posted Date

Apr 5, 2017Actual

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

Maternal and clinical characteristics associated with spontaneous second-trimester pregnancy loss (between 12 1/7 and 23 6/7 weeks of gestation) will be assessed.

Detailed Description

Maternal characteristics as age , parity, body mass index, previous abortion,previous failed IVF cycles, weight gain during pregnancy, physical activity, sexual relation and frequency, adherence to treatment, residency, medical history,surgical pelvic history, fever during pregnancy.

Clinical characteristics as multiple pregnancy, site of implantation, day of transfer, serum HCG day 14.

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

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
aborted women		women who got pregnant and have 2nd trimesteric abortion, follow up antenatal care by ultrasound and clinical monitoring	Other: follow up antenatal care
continued women		women who got pregnant and completed her pregnancy follow up antenatal care by ultrasound and clinical monitoring	Other: follow up antenatal care

Interventions

Name	Type	Description	Arm Group Labels	Other Names
follow up antenatal care	Other	ultrasound follow up of pregnancy	aborted women continued women

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
second trimester abortion		between 12 1/7 and 23 6/7 weeks of gestation)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Women aged 21-44 years with ongoing in vitro fertilization pregnancy (at least one fetus with fetal heart tones at 12 weeks of gestation)

Exclusion Criteria:

abnormal uterine cavity induced abortion for medical problem

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

44 Years

Standard Ages

Adult

Study Population

Women aged 21-44 years with ongoing in vitro fertilization pregnancy (at least one fetus with fetal heart tones at 12 weeks of gestation)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ahmed M Maged, MD	Contact	01005227404		prof.ahmedmaged@gmail.com
Adel Nada, MD	Contact			adel.nada29@gmail.com

Overall Officials

Name	Affiliation	Role
Ahmed Maged, MD	Kasr Alainy medical school	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ahmed Maged	Recruiting	Cairo		12151	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided