Protocol summary

Study aim
Effect of a High-Intensity Exercise Training Course with Nanomicelle Curcumin Supplementation on Plasma Hormonal and Biochemical Factors, Oocyte Maturation Rate, and Embryo Quality in Infertile Women with Polycystic Ovary Syndrome Undergoing Microinjection Treatment.
Design
A clinical trial with a control group, with a parallel group, a blind strain, randomized, phase 3 on 40 patients
Settings and conduct
Infertile Women With Polycystic Ovary Syndrome under the Supervision of a Gynecologist are Included in the Groups of Medicine, Exercise, Medicine along with Exercise or Control. Before and After the Treatment, Blood Samples are Taken from the Patient to Measure Biochemical Markers. The Place of the Study is in the Infertility Treatment Center of Qom University Jihad.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Periodontal Disorders (Oligomenorrhea or Amenorrhea Patients). Hirsutism, Infertility, Increased LH / FSH Ratio, Ultrasound Findings of Ovarian Size and Multiple Follicles with 2-10 mm Size, Normal Sperm Analysis, Normal Thyroid Function and Prolactin Level, No Endometriosis Exclusion Criteria: No Ovulation, Male Factor Infertility, Pelvic Organ Damage, Congenital Adrenal Hyperplasia, Thyroid Dysfunction, Cushing's Syndrome, Drug Sensitivity And Inability to Exercise.
Intervention groups
Control Group: Metformin for 12 Weeks, 3 Tablets of 500 mg Daily Intervention Group 1: for 12 Weeks Nano Micellar Curcumin (80 mg per day) + 3 Metformin Doses of 500 mg Daily Intervention Group 2: for 12 Weeks Nanomicelle Curcumin (80 mg per day) + 3 Metformin Doses of 500 mg Daily for 12 Weeks along with Exercise Intervention group 3:Metformin for 12 Weeks, 3 Tablets of 500 mg Daily along with Exercise
Main outcome variables
Sex Hormones, Oxidative Stress, Oocyte Maturation, Embryo Number, Embryo Quality

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210207050279N1
Registration date: 2024-01-10, 1402/10/20
Registration timing: registered_while_recruiting

Last update: 2024-01-10, 1402/10/20
Update count: 0
Registration date
2024-01-10, 1402/10/20
Registrant information
Name
elham elham
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 25 3270 3987
Email address
asa.elham@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-31, 1402/10/10
Expected recruitment end date
2024-08-31, 1403/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of High Intensity Interval Training(HIIT) with Nano Curcumin Supplementation on MDA,SOD,GPX,TAC, LH,FSH,TT and Oocytes Maturation , Embryos Quality in Patients with PCOs Undergoing ICSI treatment. a Randomized Placebo-Controlled Clinical Trial
Public title
Modification of Complications Caused by Polycystic Ovary Syndrome by Nano Curcumin Drug and HIIT Exercise in Women Undergoing ICSI Treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Period Disorders Hirsutism Infertility Increased LH/FSH ratio Ultrasound View in the form of Enlarged Ovaries Having Numerous Follicles with a Size of 2-10 mm The Normality of Sperm Analysis Normal Thyroid Function No Endometriosis Normal Prolactin Level Normal Hysterosalpingography
Exclusion criteria:
Infertility Factors other than Ovulation Male factor infertility Pelvic Organ Injuries Congenital Adrenal Hyperplasia Thyroid Dysfunction Cushing Syndrome Severe Liver or Kidney Diseases Active Gastric Ulcer Drug Sensitivity Intolerance of Exercise
Age
From 20 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
40 Beads are Placed in a Box, which are Numbered From 1 to 4. After Accepting Each Patient and After Obtaining Informed Consent, The Treating Physician Randomly Removes one of the Beads Inside the Box (without Seeing the Contents of the Box) and in this Way, People are Classified Into Different Groups, so that Numbers 1 belong to the HIIT Training Group, Numbers 2: Nano Curcumin Supplement, Numbers 3: HIIT and Curcumin Supplement, Numbers 4: Control Group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The Gynecologist was Fully Informed by the Project Manager about Nano Curcumin Drug and the Properties and Side Effects of the Drug. Patients were Placement in the Control and Treatment Group is the Responsibility of The Gynecologist. Patients Who Entered the Project with Full Consent, but Do not Know Whether They will be Placed in the Control or Treatment Group.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Qom University of Medical Sciences
Street address
Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town, Tehran
City
Tehran
Province
Tehran
Postal code
1467664961
Approval date
2023-11-27, 1402/09/06
Ethics committee reference number
IR.MUQ.REC.1402.194

Health conditions studied

1

Description of health condition studied
Polycystic ovary syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome

Primary outcomes

1

Description
Regulation of Sex Hormones
Timepoint
Before Taking the Drug and 12 weeks After Starting to Take the Drug
Method of measurement
Elisa Kit

2

Description
Stress Oxidative Level
Timepoint
Before Taking the Drug and 12 weeks After Starting to Take the Drug
Method of measurement
Laboratory Kits

3

Description
Oocyte and Embryo Quality
Timepoint
After Completing the Intervention
Method of measurement
Shape and Morphology

Secondary outcomes

1

Description
Pregnancy Rate
Timepoint
2 Weeks After Embryo Transfer
Method of measurement
Laboratory kits

Intervention groups

1

Description
Intervention Group: Curcumin Nano Micelle Capsule (80 mg Daily for 12 Weeks) and Metformin (500 mg Daily for 12 weeks)
Category
Treatment - Drugs

2

Description
Intervention group: HIIT ٍExercise (Three Sessions Per Week) and Nanomicelle Curcumin (80 mg daily for 12 weeks) and Metformin (500 mg Daily for 12 Weeks)
Category
Treatment - Drugs

3

Description
Intervention group: HIIT Exercise (Three Sessions per Week) and Metformin (500 mg per Day for 12 Weeks)
Category
Treatment - Drugs

4

Description
Control group: Metformin, 500 mg Three Times a Day for 12 Weeks
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Infertility Treatment Highly Specialized Center Of ACECR Qom
Full name of responsible person
Elham Asa
Street address
No 10,Floor 3, B3 Unit, Razi Building, Razi Alley, Shahid Karimi Blvd
City
Qom
Province
Ghoum
Postal code
3739164393
Phone
+98 25 3336 8378
Email
asa.elham@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Leila Naserpoor
Street address
Infertility Center of Qom University of Medical Sciences, Shabnam Ave., Isar Town, Shahid Karimi Blvd.
City
QOM
Province
Ghoum
Postal code
37131899934
Phone
+98 25 3270 0155
Email
leilanasery@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iranian academic center for education culture and research
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
Other

Person responsible for general inquiries

Contact
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Elham Asa
Position
Embryologist
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
Unit 10, 3rd Floor, Razi Building, Razi Alley, Shahid Karimi Blvd
City
Qom
Province
Ghoum
Postal code
3739164393
Phone
+98 25 3339 8378
Email
asa.elham@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Elham Asa
Position
Embryologist
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
Unit 10, 3rd Floor, Razi Building, Razi Alley, Shahid Karimi Blvd
City
ًQom
Province
Ghoum
Postal code
3739164393
Phone
+98 25 3336 8378
Email
asa.elham@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Elham
Position
Embryologist
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
Unit 10, 3rd Floor, Razi Building, Razi Alley, Shahid Karimi Blvd
City
Qom
Province
Ghoum
Postal code
3739164393
Phone
+98 25 3336 8378
Email
asa.elham@gmail.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
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
Except for Personal Data, other Outcomes and Variables can be Shared.
When the data will become available and for how long
6 Months After Printing the Results
To whom data/document is available
Researchers Working in Academic and Scientific Institutions
Under which criteria data/document could be used
Providing Accurate Information to a Gynecologist for the Treatment of Infertility and Welfare of Patients.
From where data/document is obtainable
Elham Asa(09127541614)Asa.Elham@gmail.com
What processes are involved for a request to access data/document
Access Data by Reading the Article. In Case of Request for More Information, Contact the Project Manager.
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