Extending the hCG OPU Interval | NCT02871154

Studies
Extending the hCG OPU Interval

NCT02871154

Sponsor

The Baruch Padeh Medical Center, Poriya

Status

Unknown status

Last Update Posted

Aug 18, 2016Estimated

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Infertility

Interventions

Delaying oocyte pick up beyond 39 hours post hCG

Countries

Not provided

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

Aug 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2017

Primary Completion Date

Dec 2018Estimated

Completion Date

Dec 2018Estimated

First Submitted Date

Aug 14, 2016

First Submission Date that Met QC Criteria

Aug 17, 2016

First Posted Date

Aug 18, 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

Aug 17, 2016

Last Update Posted Date

Aug 18, 2016Estimated

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

Our and others experience suggest that in some cases delaying oocyte pick up (OPU) for more than 39 hours after hCG injection may be of benefit.

We plan to apply this to 20 women in whom less than 20% of oocytes were found suitable for intracytoplasmic sperm injection. The delay will be for up to an interval of 47 hours from hCG to OPU.

Detailed Description

In IVF one encounters some women in whom a low percentage of oocytes are found in the metaphase II stage upon their retrieval. Following some incidents, in our experience as well as others', where women injected hCG too early but oocytes were still retrieved with high proportion of maturity, we decided to delay OPU intentionally in women who had low percentage oocyte maturity in previous cycles.

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

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Delay	Experimental	Delaying oocyte pick up beyond 39 hours post hCG	Other: Delaying oocyte pick up beyond 39 hours post hCG

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Delaying oocyte pick up beyond 39 hours post hCG	Other	Unlike the traditional less-than 39 hours interval from hCG injection to oocyte pick up, we will extend the interval up to 47 hours

Measure	Description	Time Frame
Conception		Two years

Eligibility Module

Eligibility Criteria

Inclusion Criteria: Previous 2 oocyte pick up cycles with 20% metaphase II oocytes in the cohort -

Exclusion Criteria:

No previous IVF history

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

38 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Izhar Ben Shlomo, MD	Contact	972-52-6124781		ibenshlomo@poria.health.gov.il
Johenny S Younis, MD	Contact	972-50-6265477		jyounis@poria.health.gov.il

Overall Officials

Name	Affiliation	Role
Odeh-L'ya Katz, PhD	Beruch Padeh Med Ctr Research Authority	Study Director

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Study results

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

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