The effect of melatonin supplemention for ovarian stimulation cycles on sleep and mood and microinjection outcomes in patients with polycystic ovary syndrom
Determination of the effect of melatonin supplementation in ovarian stimulation cycle on micro injection outcomes(number and quality of oocytes and embryos) in patient with poly cystic ovary syndrome
Design
Clinical trial with control group
Settings and conduct
patients visits and treatments and follow up and oocytes pick up are performed with the gynecologists in Avicenna infertility center clinics and operation room
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age between 20 to 40 years old, Having symptoms of polycystic ovary syndrome. Exclusion criteria: Azospermia in sperm analysis of male partner, The use of alternative infertility treatment services, Uncontrolled medical condition, Abnormal karyotype, Uterine abnormal anatomy, Immune and coagulation dysfunction
Intervention groups
Intervention group get melatonin treatment 3 mg daily (nature made company) for 6 weeks before oocyte pick up. In intervention group and control group ovarian stimulation with gonadotropins is started from the third day of the menstrual cycle (after one period of oral contraceptive pill use) and ovarian response is monitored serially in the gynecologist visits and trans vaginal Sonography , and when the ovarian follicles reach to the appropriate size, occyte pick up is performed under the vaginal Sonography guide with general anesthesia.
Main outcome variables
Number and quality of retrieved oocytes, Fertilization rate, Number and quality of embryos
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160717028967N10
Registration date:2019-06-07, 1398/03/17
Registration timing:registered_while_recruiting
Last update:2019-06-07, 1398/03/17
Update count:0
Registration date
2019-06-07, 1398/03/17
Registrant information
Name
Safora Salemi
Name of organization / entity
Shahid Chamran University of Ahvaz
Country
Iran (Islamic Republic of)
Phone
+98 83 3821 1001
Email address
e.mahmoudi@cobeldarou.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-22, 1398/03/01
Expected recruitment end date
2019-09-21, 1398/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of melatonin supplemention for ovarian stimulation cycles on sleep and mood and microinjection outcomes in patients with polycystic ovary syndrom
Public title
The effect of melatonin in patients with polycystic ovary syndrom
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 20 to 40 years old
Having symptoms of polycystic ovary syndrome
candidate of micro-injection for infertility treatment
Exclusion criteria:
Azospermia in sperm analysis of male partner
The use of alternative infertility treatment services
Uncontrolled medical condition
Abnormal karyotype
Uterine abnormal anatomy
Immune and coagulation dysfunction
Age
From 20 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are divided into two equal groups (A and B) based on a randomized six-block table that is designed by Random allocation software.
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 committee of Avecinna infertility center
Street address
Avicenna Infertility Treatment Center, No 97, Yakhchal-Shariati junction, Shariati street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1941913114
Approval date
2019-03-05, 1397/12/14
Ethics committee reference number
IR.ACECR.AVICENNA.REC.1398.002
Health conditions studied
1
Description of health condition studied
Poly Cystic Ovary Syndrome
ICD-10 code
E28.2
ICD-10 code description
Poly cystic ovarian syndrome
Primary outcomes
1
Description
Number of retrieved oocytes
Timepoint
on the day of oocyte pick up
Method of measurement
Microscopic Assessment of oocytes count by the embryologist
2
Description
Fertilization rate
Timepoint
The fertilization rate will be checked on the day after sperm injection
Method of measurement
Is calculated as percentage transformation of micro injected oocytes in to two pronuclei
3
Description
Number of embryos
Timepoint
The time of the assessment is 3 days after fertilization
Method of measurement
Microscopic assessment of the embryes count by the embryologist
4
Description
Sleep
Timepoint
Before the intervention and after 6 weeks
Method of measurement
Pittsburgh sleep quality index questionnaire,STOP Bang questionnaire and insomnia severity index questionnair
5
Description
Depression
Timepoint
Before the intervention and after 6 weeks
Method of measurement
Beck depression short Inventory
6
Description
Quality of retrieved oocytes
Timepoint
on the day of oocyte pick up
Method of measurement
Microscopic assessment of the oocytes morphology by the embryologist
7
Description
Quality of embryos
Timepoint
The time of the assessment is 3 days after fertilization
Method of measurement
Microscopic assessment of the embryes morphology by the embryologist
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Melatonin 3 mg tablets (nature made company) daily with oral contraceptive pill and Folic Acid start from the third day of the menstrual cycle before stimulation of ovaries and are continued till the oocyte pick up after the ovarian stimulation with the antagonist method in the next menstrual cycle(for 6 week)
Category
Treatment - Drugs
2
Description
Control group: Oral contraceptives and folic acid start from the third day of menstrual cycle and oocyte pick up after ovarian stimulation with antagonist method will be performed in the next menstrual cycle
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Avecinna infertility center
Full name of responsible person
Soheila Ansaripour
Street address
Avicenna Infertility Treatment Center, No 97, Yakhchal-Shariati junction, Shariati street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1941913114
Phone
+98 21 23519
Email
Soh.ansaripour@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Avicenna infertility center
Full name of responsible person
Sharare Shafiei
Street address
Avicenna Infertility Treatment Center, No 97, Yakhchal-Shariati junction, Shariati street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1941913114
Phone
+98 21 23519
Email
sh.shafiei@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Avicenna infertility center
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
Avecinna infertility center
Full name of responsible person
Dr. Soheila Ansaripour
Position
Assistant professor of infertility
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Avicenna Infertility Treatment Center, No 97, Yakhchal-Shariati junction, Shariati street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1941913114
Phone
+98 21 23519
Email
Soh.ansaripour@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Avicenna infertility center
Full name of responsible person
Dr. Soheila Ansaripour
Position
Assistant professor of infertility
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Avicenna Infertility Treatment Center, No 97, Yakhchal-Shariati junction, Shariati street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1941913114
Phone
+98 21 23519
Email
Soh.ansaripour@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Avicenna infertility center
Full name of responsible person
Katayoun Yazdchi
Position
fellowship of infertility
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Avicenna Infertility Treatment Center, No 97, Yakhchal-Shariati junction, Shariati street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1941913114
Phone
+98 21 23519
Email
katayounyazdchi@yahoo.com
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