Characterizing Follicles From Auto-transplanted Ovarian T... | NCT04905771

Studies
Characterizing Follicles From Auto-transplanted Ovarian Tissue

NCT04905771

Sponsor

Peter Humaidan

Status

Unknown status

Last Update Posted

Jun 7, 2023Actual

Enrollment

10Estimated

Phase

Not provided

Conditions

Infertility, Female

Interventions

Not provided

Countries

Denmark

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

Jun 2023

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

Feb 1, 2021Actual

Primary Completion Date

Feb 1, 2026Estimated

Completion Date

Feb 1, 2026Estimated

First Submitted Date

May 21, 2021

First Submission Date that Met QC Criteria

May 26, 2021

First Posted Date

May 28, 2021Actual

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

Jun 6, 2023

Last Update Posted Date

Jun 7, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Peter Humaidan, Professor, Regionshospitalet Viborg, SkiveSponsor-Investigator

Lead Sponsor

Peter HumaidanOTHER

Collaborators

Name	Class
Reproduktionsbiologisk Laboratorium, JMC, Rigshospitalet, København	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

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

The aim of the project is to characterize the hormonal conditions in egg follicles in women who, prior to fertility treatment, have had autotransplanted frozen ovarian tissue for the purpose of fertility preservation.

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

10Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Characterize hormone production in follicles from autotransplanted ovarian tissue	Women undergoing fertility treatment	5 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Women aged 18 years or older
Has had frozen and later autotransplanted ovarian tissue for fertility preservation purposes
Included in fertility treatment with eff retrieval at the Fertility Clinic Regional Hospital Skive
Is willing and able to give informed consent

Exclusion Criteria:

- Patients undergoing fertility treatment but have not received autotransplanted ovarian tissue for fertility preservation purposes

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

42 Years

Standard Ages

Adult

Study Population

30 women undergoing fertility treatment who has had frozen and later autotransplanted ovarian tissue for fertility preservation purposes

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Peter Humaidan, Professor	Contact	+45 78445760		peter.humaidan@midt.rm.dk

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fertility Clinic, Skive Regional Hospital	Recruiting	Skive			Denmark

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007247	Infertility, Female
D007246	Infertility

Ancestor Terms

ID	Term
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided