Comparison of the effect of indomethacin compared to not receiving indomethacin on fertility outcomes in infertile women with poor ovarian response under assisted reproductive treatment
Determination of the effect of indomethacin on fertility outcomes in infertile women with poor ovarian response treated with assisted reproductive methods
Design
Clinical trial with control group, with parallel groups, randomized, phase 3 on 60 patients with poor ovarian response under assisted reproductive treatment. The random assignment sequence will be determined using the program "Computer Random Generation".
Settings and conduct
This research will be conducted on 60 patients with poor ovarian response undergoing assisted reproductive treatment in Bandar-abbas infertility clinic. Patients will be divided into two intervention groups (receiving indomethacin rectal suppositories at an interval of 12 hours and then 24 hours after the initial trigger) and control (not receiving indomethacin).
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients aged 18 to 45 years; Absence of contraindications to the use of indomethacin; Normal semen analysis; poor ovarian response. Exclusion criteria: Patients with other endocrine disorders such as hyperprolactinemia; Polycystic ovary syndrome, etc.; Allergy to indomethacin or any of the ingredients of this product; History of acute attacks of asthma; urticaria or rhinitis as a result of treatment with aspirin or other non-steroidal anti-inflammatory drugs; Drug abuse; History of proctitis or recent rectal bleeding; Having nasal polyps with angioneurotic edema
Intervention groups
Indomethacin rectal suppository (100 mg) 12 hours apart and then 24 hours after the initial trigger compared to not receiving indomethacin.
Main outcome variables
Oocyte quality, oocytes number, Embryo number
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160524028038N12
Registration date:2022-12-02, 1401/09/11
Registration timing:registered_while_recruiting
Last update:2022-12-02, 1401/09/11
Update count:0
Registration date
2022-12-02, 1401/09/11
Registrant information
Name
Fatemeh Bazarganipour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 76 3366 6367
Email address
bazarganipour@hums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-26, 1401/09/05
Expected recruitment end date
2023-02-24, 1401/12/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of indomethacin compared to not receiving indomethacin on fertility outcomes in infertile women with poor ovarian response under assisted reproductive treatment
Public title
Indomethacin and fertility outcomes in infertile women with poor ovarian response
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged 18 to 45 years
Absence of contraindications to the use of indomethacin
Normal semen analysis
poor ovarian response
Exclusion criteria:
Patients with other endocrine disorders such as hyperprolactinemia, PCOS, etc.
History of ovarian surgery or ovarian endometrioma
Smoker
Cardiovascular disorders
Receiving drugs affecting the metabolism of indomethacin
Unwillingness to cooperate
History of peptic ulcer or recurrent active gastric ulcer
History of gastrointestinal lesions
Allergy to indomethacin or any of the ingredients of this product
History of acute attacks of asthma, urticaria, or rhinitis as a result of treatment with aspirin or other non-steroidal anti-inflammatory drugs.
Drug abuse
History of proctitis or recent rectal bleeding
Having nasal polyps with angioneurotic edema
Age
From 18 years old to 45 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
The randomization method is simple. The random allocation sequence will be determined using the "computer Random generation" computer program. The sealed envelopes encoded and non-transparent (A and B) for the allocation of subjects to intervention (A) and control (B) groups will be used.
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 Hormozgan University of Medical Sciences
Street address
Vice chancellor of research, Shahid Mohamadi Hospital, Bandarabbas, Hormozgan
City
Bandarabbas
Province
Hormozgan
Postal code
7916839319
Approval date
2022-07-25, 1401/05/03
Ethics committee reference number
IR.HUMS.REC.1401.105
Health conditions studied
1
Description of health condition studied
Female infertility due to poor ovarian response
ICD-10 code
N97.8
ICD-10 code description
Female infertility of other origin
Primary outcomes
1
Description
Oocyte Quality
Timepoint
2-3 hrs. after oocyte collection
Method of measurement
Microscopic Evaluation
2
Description
Number of retried oocyte
Timepoint
On day of oocyte retrieval
Method of measurement
Counting number of total oocytes with microscope
3
Description
Number of embryo
Timepoint
On the 2nd day after ICSI
Method of measurement
Observation with microscope
Secondary outcomes
empty
Intervention groups
1
Description
First, patients will receive 300 units of Gonal F ampoule and 150 units of human monoposal gonadotropin daily for 4 days from the second day of menstruation. Gonadotropin dose will be adjusted according to ovarian response in transvaginal ultrasound and serum estradiol concentration from day 5 of stimulation. Ultrasound will be done on the sixth day when we have at least one more follicle equal to 13. Citrotriad will start with the flexible protocol. We continue the treatment until the follicle reaches 17 mm. If the patient has more than 2 follicles of 16 mm, the trigger will be performed and 10,000 units of Human chorionic gonadotropin will be injected. Patients in the intervention group will receive indomethacin (100 mg) rectal suppositories 12 hours apart and then 24 hours after the initial trigger.
Category
Treatment - Drugs
2
Description
First, patients will receive 300 units of Gonal F recombinant FSH ampoule and 150 units of human monoposal gonadotropin daily for 4 days from the second day of menstruation. Gonadotropin dose will be adjusted according to ovarian response in transvaginal ultrasound and serum estradiol concentration from day 5 of stimulation. Ultrasound will be done on the sixth day when we have at least one more follicle equal to 13. Citrotriad will start with the flexible protocol. We continue the treatment until the follicle reaches 17 mm. If the patient has more than 2 follicles of 16 mm, the trigger will be performed and 10,000 units of HCG will be injected.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Infertility center affiliated to Hormozgan University of Medical Sciences
Full name of responsible person
Maryam Azizi
Street address
Parastar Street, Bandarabbas, Hormozgan
City
Bandarabbas
Province
Hormozgan
Postal code
7919915519
Phone
+98 76 3333 0755
Email
Maryamazizikut86@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Teymoor Aghamolaei
Street address
Shahid Mohamadi Hospital, Bandarabbas, Hormozgan
City
Bandarabbas
Province
Hormozgan
Postal code
7916839319
Phone
+98 76 3333 7192
Email
taghamolaei@hums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bandare-abbas 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
Bandare-abbas University of Medical Sciences
Full name of responsible person
Associate professor
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Vice chancellor of research, Shahid Mohamadi Hospital, Bandarabbas, Hormozgan
City
Bandarabbas
Province
Hormozgan
Postal code
7916839319
Phone
076333666365
Fax
Email
maryamazizikut86@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Maryam Azizi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Vice chancellor of research, Shahid Mohamadi Hospital, Bandarabbas, Hormozgan
City
Bandarabbas
Province
Hormozgan
Postal code
7916839319
Phone
076333666365
Email
maryamazizikut86@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Maryam Azizi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Vice chancellor of research, Shahid Mohamadi Hospital, Bandarabbas, Hormozgan
City
Bandarabbas
Province
Hormozgan
Postal code
7916839319
Phone
076333666365
Email
maryamazizikut86@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD