Hysteroscopy, Oocyte RecipientsNCT04580056
Hysteroscopy With Fundus Uterus Scratching Incision VS Office Hysteroscopy Before ET With Donor Eggs
An observational study of Hysteroscopy, Oocyte Recipients, run by Assisting Nature at 1 site in Greece.
Trial summary
A prospective randomised control trial of the impact of the fundus edometrial incision during hysteroscopy in oocyte recipients. Read more about this study
- Who is it for?
- Ages 30 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hysteroscopy, Oocyte Recipients
- What is being tested?
- Uterine fundus endometrial incision during hysteroscopy
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteGreece
- Study dates
- 1 Jan 2020to Jan 2022
- 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 30 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women 30-50 years old with infertility undergoing IVF treatment with donor oocytes. 1-2 blastocysts are transferred per cycle with endometrium preparation with Hormone Replacement Therapy.The study population has underwent hysteroscopy with fundus endometrial incision before the embryo transfer.
Who may be able to join
- oocyte acceptors
- age 30-50
- embryo transfer with Hormone Replacement Therapy
- embryo transfer within 6 months of hysteroscopy
Who cannot join
- previous uterine pathology
- sperm sample <1mil/ml
- leiomyoma
- septate uterus
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oocyte Recipients Before Embryo Transfer Randomization: Hysteroscopy With Fundus Uterus Scratching VS Hysteroscopy Without Fundus Uterus Scratching
A prospective randomised control trial of the impact of the fundus edometrial incision during hysteroscopy in oocyte recipients.
Read the detailed description
A prospective randomised control trial of the impact of the fundus edometrial incision during hysteroscopy in women without intrauterine pathology which is likely to have an adverse effect on reproductive outcomes. The study populations will be constituted by oocyte recipients.
Study group: Hysteroscopy with fundus endometrial incision Control group: Office Hysteroscopy without any endometrial injury
- Conditions
- Hysteroscopy, Oocyte Recipients
- Being tested
- Uterine fundus endometrial incision during hysteroscopy
- Keywords
- Hysteroscopy, Fundus Endometrial Incision, Oocyte acceptors, pregnancy outcome, uterine scratching
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Uterine fundus endometrial incision during hysteroscopyProcedure or surgery
Uterine fundus endometrial scratching during hysteroscopy by incision
| Study group | Role | What they receive |
|---|---|---|
| Incision Group | Women following IVF treatment with donor oocytes who underwent during hysteroscopy fundus endometrial scratching by incision, before embryo transfer. Receives: Procedure: Uterine fundus endometrial incision during hysteroscopy | |
| No incision Group | Women following IVF treatment with donor oocytes who underwent office hysteroscopy without fundus endometrial scratching by incision, before embryo transfer. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implantation Rate
Implantation rate
Measured: 6 weeks to 42 weeks after embryo transfer]
Delivery Rate
Delivery Rate
Measured: 6 weeks to 42 weeks after embryo transfer]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start1 Jan 2020
- Primary completionJan 2022 (estimated)
- Study completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hysteroscopy, Oocyte RecipientsStudies 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assisting Nature
- Sponsor type
- University, hospital or other
- Collaborators
- Aristotle University Of Thessaloniki
- Responsible party
- Principal investigator, Papanikolaou Evaggelos, Assisting Nature
- Investigators
- Evangelos Papanikolaou, PhD, Principal investigator, Assisting Nature, 3rd Department of Obstetrics and Gynaecology, Aristotle University of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04580056
- Sponsor's protocol ID
- Uterus Incision- Don
- Status last verified
- Oct 2020
- First submitted
- 2 Oct 2020
- Last updated
- 8 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Peitsidis N, Tsakiridis I, Najdecki R, Michos G, Kalogiannidis I, Athanasiadis A, Papanikolaou E. Hysteroscopic Endometrial Fundal Incision versus Hysteroscopy Only in Oocyte Recipients: A Randomized Controlled Trial Assessing The Reproductive Outcomes. Int J Fertil Steril. 2024 Jul 13;18(Suppl 1):3-9. doi: 10.22074/ijfs.2024.2009369.1523.
PubMed 39033364
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oocyte Recipients Before Embryo Transfer Randomization: Hysteroscopy With Fundus Uterus Scratching VS Hysteroscopy Without Fundus Uterus Scratching
- ClinicalTrials.gov ID
- NCT04580056
- Acronym / sponsor ID
- Uterus Incision- Don
- Conditions
- Hysteroscopy, Oocyte Recipients
- Keywords
- Hysteroscopy, Fundus Endometrial Incision, Oocyte acceptors, pregnancy outcome, uterine scratching
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Assisting NatureUniversity, hospital or other
- Collaborators
- Aristotle University Of Thessaloniki
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 8 Oct 2020 (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.
A prospective randomised control trial of the impact of the fundus edometrial incision during hysteroscopy in oocyte recipients.
Detailed description
A prospective randomised control trial of the impact of the fundus edometrial incision during hysteroscopy in women without intrauterine pathology which is likely to have an adverse effect on reproductive outcomes. The study populations will be constituted by oocyte recipients.
Study group: Hysteroscopy with fundus endometrial incision Control group: Office Hysteroscopy without any endometrial injury
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Incision Group | – | Procedure: Uterine fundus endometrial incision during hysteroscopyWomen following IVF treatment with donor oocytes who underwent during hysteroscopy fundus endometrial scratching by incision, before embryo transfer. |
| No incision Group | – | –Women following IVF treatment with donor oocytes who underwent office hysteroscopy without fundus endometrial scratching by incision, before embryo transfer. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women 30-50 years old with infertility undergoing IVF treatment with donor oocytes. 1-2 blastocysts are transferred per cycle with endometrium preparation with Hormone Replacement Therapy.The study population has underwent hysteroscopy with fundus endometrial incision before the embryo transfer.
Key inclusion criteria (4 listed)
- oocyte acceptors
- age 30-50
- embryo transfer with Hormone Replacement Therapy
- embryo transfer within 6 months of hysteroscopy
Key exclusion criteria (4 listed)
- previous uterine pathology
- sperm sample <1mil/ml
- leiomyoma
- septate uterus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Uterine fundus endometrial incision during hysteroscopyUterine fundus endometrial scratching during hysteroscopy by incision | Procedure or surgery | Incision Group |
Primary outcome
Implantation Rate
Time frame: 6 weeks to 42 weeks after embryo transfer]
Implantation rate
Delivery Rate
Time frame: 6 weeks to 42 weeks after embryo transfer]
Delivery Rate
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Derived from this study: PubMed 39033364Peitsidis N, Tsakiridis I, Najdecki R, Michos G, Kalogiannidis I, Athanasiadis A, Papanikolaou E. Hysteroscopic Endometrial Fundal Incision versus Hysteroscopy Only in Oocyte Recipients: A Randomized Controlled Trial Assessing The Reproductive Outcomes. Int J Fertil Steril. 2024 Jul 13;18(Suppl 1):3-9. doi: 10.22074/ijfs.2024.2009369.1523.
- Individual participant dataSharing planned: Undecided
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.
Evangelos Papanikolaou, PhD principal investigator
Assisting Nature, 3rd Department of Obstetrics and Gynaecology, Aristotle University of Thessaloniki
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 Hysteroscopy, Oocyte Recipients, run by Assisting Nature at 1 site in Greece.
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 4 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 8 Oct 2020. 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 Greece. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implantation Rate (time frame: 6 weeks to 42 weeks after embryo transfer]). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04580056, which also lists 1 linked publication.
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 8 Oct 2020; AzTrials last refreshed its copy on 7 Nov 2026.