Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000482460p
Ethics application status
Submitted, not yet approved
Date submitted
19/01/2025
Date registered
19/05/2025
Date last updated
19/05/2025
Date data sharing statement initially provided
19/05/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Endometriosis related symptoms during In Vitro Fertilization (IVF) : a prospective nonrandomized study
Scientific title
A comparison of the severity and worsening symptoms of endometriosis related IVF patients Vs. non endometriosis related IVF patients during ovarian stimulation
Secondary ID [1] 313756 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
endometriosis 336356 0
Condition category
Condition code
Reproductive Health and Childbirth 332890 332890 0 0
Fertility including in vitro fertilisation
Reproductive Health and Childbirth 332891 332891 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Observational study on IVF patients undergoing ovarian stimulation for reproductive, medically acceptable, reasons- research group includes patients with endometriosis and control group includes patients with no diagnosis or clinical suspicion of endometriosis.
The medical process is according to acceptable IVF protocols. To evaluate our hypothesis we will use questionnaires regarding the degree of different symptoms, using a VAS score, during the time of ovarian stimulation at several key points during the process as follow:
1. The day they joined the study
2. Five days after initiation of ovarian stimulation
3. The day of oocyte retrieval
4. One month after oocyte retrieval.
** the questionnaires will take approximately 10 minutes to answer each time.
Total observation time is 2-3 month (depends on the time between the enlistment date and the oocyte retrieval).
Intervention code [1] 330337 0
Not applicable
Comparator / control treatment
The control group are patients undergoing IVF treatment for medical indications that are not endometriosis or endometriosis suspicious reasons.
for example- patient undergoing age related fertility preservation, sperm donation, male factor infertility etc.
Patients with mechanical infertility, unexplained infertility or endometriosis related suspicious symptoms will not be included in the control group
Control group
Active

Outcomes
Primary outcome [1] 340420 0
The exacerbation rate of endometriosis related symptoms before and after ovarian stimulation for patients with endometriosis and patients without endometriosis
Timepoint [1] 340420 0
the assessment will be made at 4 time dependent points: the day of research initiation, 5 days after beginning ovarian stimulation, the day of oocyte retrieval and 1 month post oocyte retrieval.
Secondary outcome [1] 443991 0
the percentage of patients reporting on worsening symptoms before and after ovarian stimulation in both study and control groups.
Timepoint [1] 443991 0
the assessment will be made at 4 time dependent points: the day of research initiation, 5 days after beginning ovarian stimulation, the day of oocyte retrieval and 1 month post oocyte retrieval.

Eligibility
Key inclusion criteria
all patients undergoing IVF / ovarian stimulation for acceptable medical indications for their own free will can participate in this study according to the following devision:
Inclusion criteria for the research group- patients with a surgical or imaging diagnosis of endometriosis.
Inclusion criteria for the control group- Patients without diagnosis of endometriosis
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
general exclusion criteria are- patients planning an immediate pregnancy, patients with othe pain disorders (such as fibromialgia), patients disappearing from the neccessery 1 month post retrieval follow-up.
in addition, to following exclusion criteria are:
exclusion criteria for the research group- Patients with only a clinical suspicion of endometriosis, without a surgical or imaging proof of it.
exclusion criteria for the control group- patients with mechanical related infertility, patients with unexplained infertility, patients suffering from symptoms suspicious for endometriosis (as assessed by a simple questionnaire filled at the day of enrollment).

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2025
Actual
Date of last participant enrolment
Anticipated
1/03/2026
Actual
Date of last data collection
Anticipated
1/05/2026
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment outside Australia
Country [1] 26832 0
Israel
State/province [1] 26832 0

Funding & Sponsors
Funding source category [1] 318210 0
Hospital
Name [1] 318210 0
The stuff of the fertility and gynecology department of Hadassah medical center
Country [1] 318210 0
Israel
Primary sponsor type
Hospital
Name
Hadassah medical center
Address
Country
Israel
Secondary sponsor category [1] 320598 0
None
Name [1] 320598 0
Address [1] 320598 0
Country [1] 320598 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316859 0
The hadassah Helsinki ethics committee
Ethics committee address [1] 316859 0
Ethics committee country [1] 316859 0
Israel
Date submitted for ethics approval [1] 316859 0
22/12/2024
Approval date [1] 316859 0
Ethics approval number [1] 316859 0
HMO-0533-24

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 139226 0
Dr Efrat Shekel
Address 139226 0
Dr. Efrat Shekel, Hadassah medical center. address- department of obstetrics and gynecology, Ein Karem campus, Kalman Yaakov Man street, Jerusalem, Israel, Postal code 9112001, mail box 12000
Country 139226 0
Israel
Phone 139226 0
+972507680404
Fax 139226 0
Email 139226 0
[email protected]
Contact person for public queries
Name 139227 0
Efrat Shekel
Address 139227 0
Dr. Efrat Shekel, Hadassah medical center. address- department of obstetrics and gynecology, Ein Karem campus, Kalman Yaakov Man street, Jerusalem, Israel, Postal code 9112001, mail box 12000
Country 139227 0
Israel
Phone 139227 0
+972507680404
Fax 139227 0
Email 139227 0
[email protected]
Contact person for scientific queries
Name 139228 0
Efrat Shekel
Address 139228 0
Dr. Efrat Shekel, Hadassah medical center. address- department of obstetrics and gynecology, Ein Karem campus, Kalman Yaakov Man street, Jerusalem, Israel, Postal code 9112001, mail box 12000
Country 139228 0
Israel
Phone 139228 0
+972507680404
Fax 139228 0
Email 139228 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.