Investigating the preservation of ovarian reserve by endocrine suppression in women undergoing chemotherapy at reproductive ages by (GNRH) gonadotrophin hormone releasing agonists.
Determination the effect of GNRH on preservation ovarian function patients undergoing combination chemotherapy
Design
A total of 60 cancer patients with reproductive age will be studied. All patient's demographic information will be recorded.
Patients are randomly allocated into intervention and control groups. In the intervention group, GNRH is started at least 2 weeks before treatment and every 28 days during treatment. In the control group chemotherapy alone is used. Patients include non-Hodgkin's lymphoma, breast cancer, acute lymphoid leukemia.
Settings and conduct
Before starting the treatment, all patients received a detailed history and complete clinical examination and recorded in the clinical records of the patient. Menstruation is also recorded in the case.
After treatment, patients will be evaluated for menstruation, and LH, FSH and serum estradiol tests. Ovarian function was evaluated immediately after treatment and 6 months later. The data will be analyzed statistically.
Participants/Inclusion and exclusion criteria
Inclusion criteria: women with cancer who require chemotherapy; age greater than 13 and less 50 years old; good performance; absence of a history of chemotherapy; signature of informed consent form; dissatisfaction with oocyte fusion.
Exclusion criteria: pregnancy / lactation; incidence of drug complications; history of thromboembolic events; history of osteoporotic fractures; lack of cooperation.
Intervention groups
intervention group: Analogue GNRH with chemotherapy.
Control group: chemotherapy without GNRH.
Main outcome variables
Maintain ovarian function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181224042091N2
Registration date:2019-06-03, 1398/03/13
Registration timing:prospective
Last update:2019-06-03, 1398/03/13
Update count:0
Registration date
2019-06-03, 1398/03/13
Registrant information
Name
Zahra Mozaheb
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3833 2711
Email address
mozahebz@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-05, 1398/03/15
Expected recruitment end date
2021-06-05, 1400/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the preservation of ovarian reserve by endocrine suppression in women undergoing chemotherapy at reproductive ages by (GNRH) gonadotrophin hormone releasing agonists.
Public title
Preserving fertility after chemotherapy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Women with cancer who require chemotherapy
Age of more than 13 and less than 50 years old
Good performance (ECOG: 0-1
No history of previous chemotherapy
Sign a Consent Form
Dissatisfaction with oocyte fusion
Exclusion criteria:
Pregnancy / Breastfeeding2. 3. 4. 6.
Hypersensitivity reaction or significant side effect of the drug
History of thromboembolic events in the patient
The history of osteoporotic fractures
Patient does not cooperate in the correct treatment process in accordance with the recommended guidelines
Age
From 13 years old to 50 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Using a randomized list of patients prepared by software, they are divided into two groups by simple randomization.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics commitee of Mashhad University of Medical Sciences
Street address
Daneshgah st, ghorashi building,Research and Technology Deputy
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2019-05-09, 1398/02/19
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1398.037
Health conditions studied
1
Description of health condition studied
Preserving fertility following chemotherapy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Determination of the effect of GNRH on preservation of fertility and ovarian function in patients undergoing combined chemotherapy
Timepoint
Check immediately and 6 months after chemotherapy
Method of measurement
Perform ovary function assessment tests
2
Description
Menstural recovery
Timepoint
6 months after treatment
Method of measurement
Question from the patient
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The GNRH intervention group is prescribed at least 2 weeks before starting treatment and every 28 days during treatment with a chemotherapy regimen.
Category
Rehabilitation
2
Description
Control group: Control group: In this group chemotherapy is given without prescribing GNRH or placebo. The patient receives chemotherapy alone.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam-Raza hospital
Full name of responsible person
Zahra Mozaheb
Street address
Imam Reza hospital,Imam Reza square،Ebnesina St,
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3859 8818
Email
Mozahebz@mums.ac.ir
Web page address
http://www.mums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi phd
Street address
Deputy of Research and Technology of the Mashhad University of Medical Science, opposite University of Ave. 18, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 2081
Email
vcresearch@mums.ac.ir
Grant name
Grant code / Reference number
Mashhad University of Medical Sciences
Is the source of funding the same sponsor organization/entity?