Evaluation of the effect of sildenafil plus melatonin on fertility outcomes in infertile women with poor ovarian response undergoing assisted reproductive treatment.
Evaluation of the effect of sildenafil plus melatonin on fertility outcomes in infertile women with poor ovarian response undergoing assisted reproductive treatment.
Design
Clinical trial with a control group; with parallel groups; Randomized; Designed in 88 patients
Settings and conduct
This research will be conducted on 88 patients with poor ovarian response undergoing assisted reproductive treatment in Bandar Abbas Infertility Center and the patients will be divided into four groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Aged 18 to 45 years; Not using other vasodilator drugs such as nitric oxide and calcium channel blockers; Normal semen analysis; poor ovarian response.
Exclusion: Patients with other endocrine disorders such as hyperprolactinemia, PCOS, etc.; history of ovarian surgery or ovarian endometrioma; smoker; cardiovascular disorders; unwillingness to cooperate; sildenafil sensitivity and intolerance to side effects (hot flashes, vision disorders, severe drop in blood pressure and hearing disorders)
Intervention groups
Intervention group A: sildenafil starting from the first day of the cycle until the day of egg retrieval) along with inofolic starting from the first day of the previous cycle for 40 days; Intervention group B: melatonin starting from the first day of the cycle until the day of egg retrieval along with inofolic starting from the first day of the previous cycle for 40 days; Intervention group C: melatonin , starting from the first day of the cycle until the day of egg retrieval along with sildenafil starting from the first day of the cycle until the day of retrieval Ovum with Inofolic starting from the first day of the previous cycle for 40 days; control group: Inofolic starting from the first day of the previous cycle for 40 days
Main outcome variables
Oocyte quality, oocytes number, Embryo number
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160524028038N15
Registration date:2023-01-14, 1401/10/24
Registration timing:registered_while_recruiting
Last update:2023-01-14, 1401/10/24
Update count:0
Registration date
2023-01-14, 1401/10/24
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
2023-01-06, 1401/10/16
Expected recruitment end date
2023-04-05, 1402/01/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of sildenafil plus melatonin on fertility outcomes in infertile women with poor ovarian response undergoing assisted reproductive treatment.
Public title
Evaluation of the effect of sildenafil and melatonin on fertility outcomes in women with poor ovarian response
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Aged 18 to 45 years
Not using other vasodilator drugs such as nitric oxide and calcium channel blockers
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
Unwillingness to cooperate
Sildenafil sensitivity and intolerance to side effects (hot flashes, vision disorders, severe drop in blood pressure and hearing disorders)
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:
88
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، B ، C ، D) for the allocation of subjects to intervention (A، B ، C) and control (D) 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
2022-12-07, 1401/09/16
Ethics committee reference number
IR.HUMS.REC.1401.305
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
Intervention group A: Sildenafil (sildenafil citrate 25 mg daily; Visarsin) starting from the first day of the cycle until the day of egg retrieval) along with Inofolic (Inofolic powder 4 grams daily) starting from the first day of the previous cycle for 40 days
Category
Treatment - Drugs
2
Description
Intervention group B: Melatonin (3 mg melatonin tablets daily; Razak Pharmaceutical Company, Iran) starting from the first day of the cycle until the day of egg retrieval along with inofolic (inofolic powder 4 grams daily) starting from the first day of the previous cycle for 40 days
Category
Treatment - Drugs
3
Description
Intervention group C: Melatonin (daily 3 mg of melatonin tablets (Razak Pharmaceutical Company, Iran), starting from the first day of the cycle until the day of egg retrieval with sildenafil (daily 25 mg of sildenafil citrate; Visarsin) starting from the first day of the cycle until the day of egg retrieval with inofolic (inofolic powder 4 grams daily) starting from the first day of the previous cycle for 40 days
Category
Treatment - Drugs
4
Description
Control group: Inofolic (inofolic powder 4 grams daily) starting from the first day of the previous cycle for 40 days
Category
Treatment - Other
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
Maryam Azizi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Parastar Street, Bandarabbas, Hormozgan
City
Bandarabbas
Province
Hormozgan
Postal code
7919915519
Phone
+98 76 3333 0755
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
Specialist
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
Specialist
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