The Number of Blastocysts Formed in the Outcome of Freeze... | NCT03463278

Studies
The Number of Blastocysts Formed in the Outcome of Freeze All Strategy: COMFFETI Trial, Cumulative Delivery Rate

NCT03463278

Sponsor

Assisting Nature

Status

Unknown status

Last Update Posted

Oct 8, 2020Actual

Enrollment

160Estimated

Phase

Not provided

Conditions

Pregnancy, Ovarian

Interventions

Pregnancy Rate

Countries

Greece

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

Oct 2020

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

Nov 1, 2013Actual

Primary Completion Date

Dec 31, 2021Estimated

Completion Date

Dec 31, 2021Estimated

First Submitted Date

Mar 2, 2018

First Submission Date that Met QC Criteria

Mar 10, 2018

First Posted Date

Mar 13, 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

Oct 6, 2020

Last Update Posted Date

Oct 8, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

A prospective study of the blastulation rate in the outcome of the Freeze all strategy

Detailed Description

A prospective study of the blastulation rate in women under the age of 40 years following Freeze all strategy, according to AMH levels and sperm parameters.

Study group 1: number of vitrified blastocysts 0-4 Study group 2: number of vitrified blastocysts 5-7 Study group 3: number of vitrified blastocysts >7

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

160Estimated

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
0-4 blastocysts	group A: cumulative pregnancy rate of 0-4 blastocysts vitrified	Diagnostic Test: Pregnancy Rate
5-7 blastocysts	group B: cumulative pregnancy rate of 5-7 blastocysts vitrified	Diagnostic Test: Pregnancy Rate
>7 blastocysts	group C: cumulative pregnancy rate of >7 blastocysts vitrified	Diagnostic Test: Pregnancy Rate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pregnancy Rate	Diagnostic Test	The pregnancy and live birth rate according to number of blastocysts formed in our three groups	0-4 blastocysts 5-7 blastocysts

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cumulative Live Birth rate according to blastulation rate	Cumulative Live Birth rate according to blastulation rate	5 days of embryo culture

Secondary Outcomes

Measure	Description	Time Frame
Cumulative Pregnancy rate according to blastulation rate	Cumulative Pregnancy rate according to blastulation rate	5 days of embryo culture

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

primary infertility
age 20-39 years;
body mass index (BMI) 18-29kg/m2;
regular menstrual cycle of 26-35days,
presumed to be ovulatory;
>1mil/ml spermatozoa;
short antagonist protocol

Exclusion Criteria:

poor responders;
age ≥40;
TESE sperm;
PGS cycles;
donor oocytes;
donor sperm

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

39 Years

Standard Ages

Adult

Study Population

Women aged 20-39 years old following blastocyst culture after ICSI cycle in Freeze all Strategy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Tatiana Chartomatsidou, MSc	Contact	00302310424294		embryology@assistingnature.gr

Overall Officials

Name	Affiliation	Role
Evangelos Papanikolaou, MD, PhD	Assisting Nature	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Assisting Nature	Recruiting	Thessaloniki		57001	Greece

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D065172	Pregnancy, Ovarian

Ancestor Terms

ID	Term
D011271	Pregnancy, Ectopic
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D018873	Pregnancy Rate

Ancestor Terms

ID	Term
D014798	Vital Statistics
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided