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Effect of N-acetyl cysteine on oxidative stress biochemical factors and IVF/ICSI outcomes in women with endometrioma: A randomized, double-blinded, phase III Clinical Trial

Protocol summary

Study aim
To evaluate determine the effect of N-acetyl cysteineon improving oocyte quality, reduction of stress oxidative markers, and ongoing pregnancy rate in endometrioma patients who underwent IVF/ICSI cycles
Design
A clinical trial with a control group (placebo), parallel group, double-blind, randomized, phase 3 on 140 patients, used 10 and 4 permutation blocks for randomization.
Settings and conduct
A total of 140 patients with endometrioma, eligible for the study, who underwent IVF / ICSI cycles, randomized into two groups of intervention and control (placebo) by observing ethical points. This is a double-blind study in the form of patient and researcher blindness.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age between 20 and 42 years old; Ultrasound or laparoscopic diagnosis of moderate to sever endometrioma (endometriosis stage III and IV); Serum AMH levels between 0.7 and 4.5 ng/ml; standard long GnRH and antagonist ovulation stimulation cycle; Body mass index (BMI) <30 kg/m2. Non-inclusion criteria: congenital uterine malformations; severe male infertility (TESE, PESA); past medical history of asthma.
Intervention groups
Participants who randomly assigned in the intervention group, during 6 weeks simultaneous to start standard long agonist protocol or E2 priming with antagonist induction, will be received 1200 (2×600) mg of effervescent tablets of NAC daily. Blood will collect before the intervention and at the time of oocyte retrieval, in addition to, follicular fluid will be obtained from the mature follicles. Also, we measure severity of dysmenorea by visual analogue scale (VAS) technique.
Main outcome variables
MII oocyte number and quality

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210619051619N1
Registration date: 2021-10-29, 1400/08/07
Registration timing: registered_while_recruiting

Last update: 2021-10-29, 1400/08/07
Update count: 0
Registration date
2021-10-29, 1400/08/07
Registrant information
Name
Parvaneh Afsharian
Name of organization / entity
Royan Institute
Country
Iran (Islamic Republic of)
Phone
+98 21 2356 2674
Email address
p.afsharian@royan-rc.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-13, 1400/01/24
Expected recruitment end date
2023-09-23, 1402/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of N-acetyl cysteine on oxidative stress biochemical factors and IVF/ICSI outcomes in women with endometrioma: A randomized, double-blinded, phase III Clinical Trial
Public title
N-acetyl cysteine and endometrioma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 20 and 42 years old Ultrasound or laparoscopic diagnosis of moderate to sever endometrioma (endometriosis stage III and IV) Serum AMH levels between 0.7 and 4.5 ng/ml Standard long GnRH and antagonist ovulation stimulation cycle Body mass index (BMI) <30 kg/m2
Exclusion criteria:
Non-inclusion criteria: Congenital uterine malformations Severe male infertility (TESE, PESA) Past medical history of asthma
Age
From 20 years old to 42 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
Sample size
Target sample size: 140
Randomization (investigator's opinion)
Randomized
Randomization description
The permuted blocks is method for random allocation. The size of the blocks varies, including 10 blocks and 4 blocks. The allocation ratio is equal in both groups. As soon as the included patient a unique identification code is assigned to the patient and will not change during the study.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants, principle investigator, and healthcare providers do not have information about two study groups.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Royan infertility institute
Street address
Number 12, East Hafez Avenue, Bani Hashem Street, Soleimani Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1665659911
Approval date
2019-07-16, 1398/04/25
Ethics committee reference number
IR.ACECR.ROYAN.REC.1398.111

Health conditions studied

1

Description of health condition studied
Endometrioma
ICD-10 code
N80.1
ICD-10 code description
Endometriosis of ovary

Primary outcomes

1

Description
MII oocyte number and quality
Timepoint
Immediately after oocyte puncture
Method of measurement
Observation of oocytes that were mature at the time of oocyte collection

Secondary outcomes

1

Description
Measurement of TAC oxidative stress marker in blood plasma
Timepoint
Before intervention and 6 weeks after intervention
Method of measurement
ELISA

2

Description
Measurement of SOD oxidative stress marker in blood plasma
Timepoint
Before intervention and 6 weeks after intervention
Method of measurement
ELISA

3

Description
Measurement of TAC oxidative stress marker in folicular fluid
Timepoint
After oocyte puncture
Method of measurement
ELISA

4

Description
Measurement of SOD oxidative stress marker in folicular fluid
Timepoint
After oocyte puncture
Method of measurement
ELISA

5

Description
Cleaved embryo numbers
Timepoint
2-3 days after oocyte puncture
Method of measurement
2-3 days embryo from fertilization

6

Description
Blastocyst numbers
Timepoint
5 days after oocyte puncture and sperm insemination
Method of measurement
The stage the embryo reaches after 5 days in culture from the egg retrieval

7

Description
Clinical pregnancy rate
Timepoint
4-6 weeks after embryo transfer
Method of measurement
The observation of gestational sac on ultrasound examination two-three weeks after positive serum βhCG

8

Description
Fertilization rate
Timepoint
2-5 days after sperm insemination
Method of measurement
Percentage of transformation of micro injected oocytes into two pronuclei embryo

Intervention groups

1

Description
Intervention group: Participants who randomly assigned in the intervention group, during 6 weeks simultaneous to start standard long agonist protocol or antagonist induction, will be received 1200 (2×600) mg of effervescent tablets of NAC daily. Blood will collect before the intervention and at the time of oocyte retrieval (end of 6 week), in addition to, follicular fluid will be obtained from the mature follicles. Also, we will measure severity of dysmenorea by visual analogue scale (VAS) technique.
Category
Treatment - Drugs

2

Description
Control group: Participants who randomly assigned to the control group, during 6 weeks simultaneous to start the standard long agonist protocol, or antagonist induction, will be received 1200 (2×600) mg of placebo tablets of NAC daily. Blood will collect before the intervention and at the time of oocyte retrieval, in addition to, follicular fluid will be obtained from the mature follicles. Also, we measure severity of dysmenorrhea by visual analogue scale (VAS) technique.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Royan Institute
Full name of responsible person
Abdolhossein Shahverdi
Street address
Royan alley, East Hafez Avenue, Bani Hashem Street, Soleimani Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1665659911
Phone
+98 21 2356 2211
Fax
+98 21 2230 6481
Email
shahverdi@royaninstitute.org

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Royan Institute
Full name of responsible person
Abdolhossein Shahverdi
Street address
Royan alley, East Hafez Avenue, Bani Hashem Street, Soleimani Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1665659911
Phone
+98 21 2356 2211
Email
shahverdi@royaninstitute.org
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Royan Institute
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
Royan Institute
Full name of responsible person
Parvaneh Afsharin
Position
Associated professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Genetics
Street address
Royan alley, East Hafez Avenue, Bani Hashem Street, Soleimani Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1665659911
Phone
+98 21 2356 2674
Email
p.afsharian@royan-rc.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Royan Institute
Full name of responsible person
Parvaneh Afsharian
Position
Associated professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Genetics
Street address
Royan alley, East Hafez Avenue, Bani Hashem Street, Soleimani Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1665659911
Phone
+98 21 2356 2674
Email
p.afsharian@royan-rc.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Royan Institute
Full name of responsible person
Zahra Chekini
Position
Resercher
Latest degree
Master
Other areas of specialty/work
Medical Genetics
Street address
Royan alley, East Hafez Avenue, Bani Hashem Street, Soleimani Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1665659911
Phone
+98 21 2356 2643
Email
zahra_chekini@ymail.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
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