Infertility, FemaleNCT04905771
Characterizing Follicles From Auto-transplanted Ovarian Tissue
An observational study of Infertility, Female, run by Peter Humaidan at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Female
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Feb 2021to 1 Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 42 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: 30 women undergoing fertility treatment who has had frozen and later autotransplanted ovarian tissue for fertility preservation purposes
Who may be able to join
- 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
Who cannot join
- Patients undergoing fertility treatment but have not received autotransplanted ovarian tissue for fertility preservation purposes
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Fertility Clinic, Skive Regional Hospital
Skive
Peter Humaidan, DMSc, +4578445760, fertilitetsklinikken@midt.rm.dk
About this study
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.
- Conditions
- Infertility, Female
- Keywords
- Infertility
- Medical subject headings
- Infertility, Female, Infertility
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterize hormone production in follicles from autotransplanted ovarian tissue
Women undergoing fertility treatment
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2021
- Study start1 Feb 2021
- Primary completion1 Feb 2026 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peter Humaidan
- Sponsor type
- University, hospital or other
- Collaborators
- Reproduktionsbiologisk Laboratorium, JMC, Rigshospitalet, København
- Responsible party
- Sponsor-investigator, Peter Humaidan, Regionshospitalet Viborg, Skive
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04905771
- Sponsor's protocol ID
- OTT-study2021
- Status last verified
- Jun 2023
- First submitted
- 21 May 2021
- Last updated
- 7 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterizing Follicles From Auto-transplanted Ovarian Tissue
- ClinicalTrials.gov ID
- NCT04905771
- Acronym / sponsor ID
- OTT-study2021
- Conditions
- Infertility, Female
- Keywords
- Infertility
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Peter HumaidanUniversity, hospital or other
- Collaborators
- Reproduktionsbiologisk Laboratorium, JMC, Rigshospitalet, København
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 28 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 30 women undergoing fertility treatment who has had frozen and later autotransplanted ovarian tissue for fertility preservation purposes
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Patients undergoing fertility treatment but have not received autotransplanted ovarian tissue for fertility preservation purposes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Characterize hormone production in follicles from autotransplanted ovarian tissue
Time frame: 5 years
Women undergoing fertility treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2023.
- Individual participant dataSharing planned: No
Related trials for Infertility, Female
RecruitingObservational study
Biorepository in Participants Who Undergo OTC for Gonadotoxic Therapy
Acute Ovarian Failure, Infertility
Not yet recruitingObservational study
Linzagolix in Adenomyosis and Recurrent Implantation Failure
Adenomyosis of Uterus, Implantation Failure
Not yet recruitingObservational study
Low TGF-β and Embryo Implantation in the Context of Assisted Reproductive Technology: Confirmation of a Biomarker Predictive of Success and Characterization of the Immune Microenvironment.
Infertility, Female, Pregnancy Related
RecruitingObservational study
The Effects of Uterine Fibroids on Pregnancy in Women
Female Infertility, Uterine Fibroid
Not yet recruiting
Intra-ovarian CAPA-IVM vs Standard IVM
Infertility (IVF Patients), Infertility
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, Female, run by Peter Humaidan at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peter Humaidan, Professor (+45 78445760, peter.humaidan@midt.rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterize hormone production in follicles from autotransplanted ovarian tissue (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2023; AzTrials last refreshed its copy on 31 Oct 2026.