Determination of the effect of melatonin on in vitro fertilization (IVF)
Design
Randomizes clinical trials with control groups, in parallel groups, double blind in phase 3 on 320 individuals, envelope method will be used to randomization .
Settings and conduct
Study will be conducted at the Fatemieh hospital in Hamadan on infertile women with PCOS. patients will be randomly assigned to two intervention groups (receiving melatonin + metformin and folic acid) and control group (receiving metformin and folic acid). In order to blind the study participants, metformin and melatonin capsules will be available in same shape and size(single blind).
Participants/Inclusion and exclusion criteria
inclusion criteria: Women with PCOS under 40 years old underwent IVF for the first or second time, with hyperendrogenism symptom, abnormal menstrual cycles (oligomenorrhea and amenorrhea), normal uterine cavity and normal spermogram in their husband Conditions for not entering the study: Existence of underlying disease, drug interactions, use of hormonal drugs in the last three months and defects in adequate ovarian response
Intervention groups
Intervention group:
Will be treated with metformin and folic acid plus melatonin From the fifth day of menstruation until the time of Ovarian removal
control group:
Will be treated with metformin and folic acid without melatonin From the fifth day of menstruation until the time of Ovarian removal
Main outcome variables
Clinical pregnancy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151123025202N11
Registration date:2020-06-30, 1399/04/10
Registration timing:prospective
Last update:2020-06-30, 1399/04/10
Update count:0
Registration date
2020-06-30, 1399/04/10
Registrant information
Name
Abbas Moradi
Name of organization / entity
Hamedan University of Medical Of Science
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0097
Email address
a.moradi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-22, 1399/05/01
Expected recruitment end date
2022-07-23, 1401/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Effect of Melatonin on In Vitro Fertilization (IVF) in Women with Poly Cystic Ovarian
Public title
In Vitro Fertilization
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age <40 years
No Symptoms of hyperendrogenism
Abnormal menstrual cycles
Use IVF assisted reproductive techniques for the first or second time
No fertility problems in the patient's spouse
Natural uterine cavity according to hysterosalpingography result
Exclusion criteria:
Presence of underlying disease
Drug Interactions
Use of hormonal drugs in the last three months
Inadequate ovarian response defects
Age
To 40 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
320
Randomization (investigator's opinion)
Randomized
Randomization description
We made 16 cards and write letters MT on 8 for Metformin group and on the other 8 letters ML for Melatonin group. Then put them inside the envelope with aluminum wrap and put in a box. At the time of patient arrival, one of the envelopes randomly will be selected and open it, based on selected letter MT or ML patients will be assigned to Metformin or melatonin group and the opened envelope is left out. After completing all the envelopes, we return them to the box and repeat this process up to 20 times to reach the specified sample size.
Blinding (investigator's opinion)
Single blinded
Blinding description
Melatonin and metformin capsules will be available in the same shapes as A and B labels.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamadan University of Medical Science
Street address
ُShahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838697
Approval date
2020-06-16, 1399/03/27
Ethics committee reference number
Ir.Umsha.rec.1399.302
Health conditions studied
1
Description of health condition studied
Infertility due to polycystic ovary syndrome
ICD-10 code
N97.9
ICD-10 code description
Female infertility, unspecified
Primary outcomes
1
Description
Chemical pregnancy
Timepoint
14 day after intra uterine insemination
Method of measurement
B_HCG
Secondary outcomes
1
Description
Clinical Pregnancy
Timepoint
6 and 20 weeks after B-HCG positive
Method of measurement
sonography
Intervention groups
1
Description
Intervention group: After initial evaluations by a physician and doing uterine and ovarian ultrasounds on days 1 to 3 of the menstrual cycle will be treated with metformin plus melatonin and folic acid from the fifth day of menstruation until ovulation., At tenth day of menstruation, hCG will be prescribed and another ultrasound will be performed to check endometrium thickness , AFC and follicle size. If necessary, 75 HMG units intramuscular injected. Vaginal ultrasound is performed until a suitable follicle size (greater than or equal to 18 mm) observed. After 36-40 hours, patients undergo IUI.
Category
Treatment - Drugs
2
Description
Control group: After initial evaluations by a physician and doing uterine and ovarian ultrasounds on days 1 to 3 of the menstrual cycle will be treated with folic acid and metformin without melatonin from the fifth day of menstruation until ovulation., At tenth day of menstruation, hCG will be prescribed and another ultrasound will be performed to check endometrium thickness , AFC and follicle size. If necessary, 75 HMG units intramuscular injected. Vaginal ultrasound is performed until a suitable follicle size (greater than or equal to 18 mm) observed. After 36-40 hours, patients undergo IUI.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemieh hospital
Full name of responsible person
Dr Mahnaz Yavangi
Street address
Pasdaran
City
Hamedan
Province
Hamadan
Postal code
6517789971
Phone
+98 81 1827 7459
Fax
+98 81 1828 3939
Email
fatemieh@umsha.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
dr Saeid Bashirian
Street address
Shahid Fahmide Ave
City
Hamedan
Province
Hamadan
Postal code
6517838677
Phone
+98 81 3838 0717
Fax
+98 81 3838 0130
Email
vc_research@umsha.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Abbas Moradi
Position
Coach
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Shahid Vahmideh Ave
City
Hamedan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0097
Fax
+98 81 3838 0208
Email
a.moradi@umsha.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Abbas Moradi
Position
MSc in epidemiology/ Comunity Medicine MS
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Shahid Fahmideh Ave
City
Hamedan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0557
Fax
Email
a.moradi@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Abbas Moradi
Position
Coach
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
ُShahid Fahmideh Ave
City
Hamedan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0097
Fax
+98 81 3838 0208
Email
a.moradi@umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available