NCT04905771

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 21, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 28, 2021

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

June 7, 2023

Status Verified

June 1, 2023

Enrollment Period

5 years

First QC Date

May 21, 2021

Last Update Submit

June 6, 2023

Conditions

Infertility, Female

Keywords

Infertility

Outcome Measures

Primary Outcomes (1)

  • Characterize hormone production in follicles from autotransplanted ovarian tissue

    Women undergoing fertility treatment

    5 years

Eligibility Criteria

Age18 Years - 42 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fertility Clinic, Skive Regional Hospital

Skive, Denmark

RECRUITING

MeSH Terms

Conditions

Infertility, FemaleInfertility

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Central Study Contacts

Peter Humaidan, Professor

CONTACT

+45 78445760peter.humaidan@midt.rm.dk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 21, 2021

First Posted

May 28, 2021

Study Start

February 1, 2021

Primary Completion

February 1, 2026

Study Completion

February 1, 2026

Last Updated

June 7, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)