Does Premature Luteinization Matter? | NCT03001492

Studies
Does Premature Luteinization Matter?

NCT03001492

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Dec 26, 2016Estimated

Enrollment

200Estimated

Phase

Not provided

Conditions

Premature Progesterone Rise

Interventions

Not provided

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

Dec 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

Dec 2016

Primary Completion Date

Jun 2018Estimated

Completion Date

Not provided

First Submitted Date

Dec 17, 2016

First Submission Date that Met QC Criteria

Dec 20, 2016

First Posted Date

Dec 23, 2016Estimated

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

Dec 23, 2016

Last Update Posted Date

Dec 26, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Osama Saber Thabet Abdalmageed, Lecturer of OBGYN, Women Health Hospital, Assiut Univerisity, Assiut UniversityPrincipal Investigator

Lead Sponsor

Assiut UniversityOTHER

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

Elevation of serum progesterone on the day of ovulation triggering in IVF/ICSI cycles is suggested to be associated with compromized outcomes. Others found that this rise didnot affect the IVF/ICSI outcomes. It is still controversal if premature luteinization would affect the IVF/ICSI outcomes.

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

200Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinical pregnacy rate		14 days after the day of embryo transfer (ET)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Planned fresh Embryo transfer

Exclusion Criteria:

Cancelation of the embryo transfer for any reason

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

42 Years

Standard Ages

Adult

Study Population

All the women undergo controlled ovarian hyperstimulation for IVF/ICSI. only fresh cycles will be involved

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Osama Abdalmageed	Contact			drosamast1981@gmail.com

Overall Officials

Name	Affiliation	Role
Osama Abdalmageed	Women health center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Osama Abdalmageed	Recruiting	Asyut	Non-US/Non-Canadian	71111	Egypt

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19224360	Background	Sonmezer M, Pelin Cil A, Atabekoglu C, Ozkavukcu S, Ozmen B. Does premature luteinization or early surge of LH impair cycle outcome? Report of two successful outcomes. J Assist Reprod Genet. 2009 Mar;26(2-3):159-63. doi: 10.1007/s10815-009-9299-5. Epub 2009 Feb 18.