Objectives: the investigation of oral melatonin effect on the mean number of the retrieved oocytes, the mean metaphase II (MII) oocyte counts, the degenerate oocyte rates, the fertilization rate, the embryo quality, the biochemical pregnancy rate, and the serum level of progesterone in mid luteal phase in women undergoing IVF.
Design: a randomized controlled clinical trial study, single blind, Block Balanced Randomization, and Parallel
Setting, conduct and intervention: All of the women undergoing IVF are evaluated by a physician. One hundred women undergoing IVF are eligible for inclusion in this trial. Women are divided into two groups. The study group (group A, n=50) is underwent the IVF with melatonin administration and the control group (group B, n=50) without melatonin and finally the IVF outcomes are compared between the two groups.
Major inclusion criteria: Age 18-42 yrs.; normal level of serum steroidal hormones; agonist long protocol of controlled ovarian stimulation; male factor; tubal factor; and unexplained infertility.
Exclusion criteria: hypertension; diabetes mellitus; myoma; adenomyosis; a congenital uterine anomaly; ovarian cyst; use of estrogens; progesterone; androgens; or chronic use of any medication; including non-steroidal anti-inflammatory agents or anticonvulsants, smoking; moderate/severe endometriosis.
Variables: Total number of the oocytes; the metaphase II (MII) oocyte counts; the degenerate oocyte counts; the fertilization rate; the embryo quality; the biochemical pregnancy rate
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015042912307N4
Registration date:2015-06-15, 1394/03/25
Registration timing:registered_while_recruiting
Last update:
Update count:1
Registration date
2015-06-15, 1394/03/25
Registrant information
Name
Fatemeh Sadat Hoseini
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8890 7062
Email address
fshoseini@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tehran University of Medical Sciences
Expected recruitment start date
2015-03-20, 1393/12/29
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
To assess the effect of oral melatonin administration on clinical outcomes in women undergoing in-vitro fertilisation (IVF)
Public title
To assess the effect of oral melatonin administration on clinical outcomes in women undergoing in-vitro fertilisation (IVF)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age 18-42 yrs.; normal level of serum steroidal hormones; agonist long protocol of controlled ovarian stimulation; male factor; tubal factor; and unexplained infertility.
Exclusion criteria: hypertension; diabetes mellitus; myoma; adenomyosis; a congenital uterine anomaly; ovarian cyst; use of estrogens; progesterone; androgens; or chronic use of any medication; including nonsteroidal anti-inflammatory agents or anticonvulsants, smoking; moderate/severe endometriosis.
Age
From 18 years old to 42 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Design: a randomized controlled clinical trial study, single blind, Block Balanced Randomization, and Parallel
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Poorsina St., Keshavarz Blvd. Tehran
City
Tehran
Postal code
Approval date
2014-01-12, 1392/10/22
Ethics committee reference number
103788
Health conditions studied
1
Description of health condition studied
infertility
ICD-10 code
N97
ICD-10 code description
female infertility
Primary outcomes
1
Description
the mean number of the oocytes
Timepoint
oocyte pick up day
Method of measurement
Microscopic assay
2
Description
the mean metaphase II (MII) oocyte counts
Timepoint
oocyte pick up day
Method of measurement
Microscopic assay
3
Description
the degenerate oocyte counts
Timepoint
oocyte pick up day
Method of measurement
Microscopic assay
4
Description
the fertilization rate
Timepoint
24 hours after ICSI
Method of measurement
Microscopic assay
5
Description
the embryo quality
Timepoint
24 hours after ICSI
Method of measurement
Microscopic assay
6
Description
the biochemical pregnancy rate
Timepoint
2 weeks after embryo transfer
Method of measurement
B.HCG titer
Secondary outcomes
1
Description
the Serum level of progesterone in mid luteal phase
Timepoint
one week after embryo transfer
Method of measurement
Serum progestrone titer
Intervention groups
1
Description
Intervention group:Oral melatonin tablet is administered to fifty women undergoing IVF as an intervention group. Daily melatonin dosage is 3 mg orally (nature made,USA) taken at 22:00–23:00 pm. The written informed consent is taken from all of the patients administration of melatonin begins from the 21th day of the previous menstrual cycle until the day of oocyte retrieval. Patients undergo in vitro fertilization with a standardized ovarian-stimulation protocol, GnRH agonist. The daily administration of Buserelin acetate (Suprefact, Germany) 500 μg is started preceding the IVF cycle from day 21. Ovarian stimulation is started on the 3rd day of the current menstrual cycle by injection of rFSH Follitropin alfa (Gonal F, Italy) at a daily dose of 150 to 225 IU in each group. Administration of Buserelin is continued until hCG is injected. When at least 3 follicles with a mean diameter of 17 mm are developed (evaluated by transvaginal sonography), hCG (Choriomon, Switzerland) 5000 IU/2/IM is injected. About 34–36 after hCG injection, oocyte retrieval is performed
Category
Treatment - Drugs
2
Description
Control group:
Oral melatonin tablet is not administered to fifty women undergoing IVF as a control group. We do not use a placebo in the control group due to logistic restraints. Patients undergo in vitro fertilization with a standardized ovarian-stimulation protocol, GnRH agonist. The daily administration of Buserelin acetate 500 (Suprefact, Germany) μg is started preceding the IVF cycle from day 21. Ovarian stimulation is started on the 3rd day of the current menstrual cycle by injection of rFSH Follitropin alfa (Gonal F, Italy) at a daily dose of 150 to 225 IU in each group. Administration of Buserelin is continued until hCG is injected. When at least 3 follicles with a mean diameter of 17 mm are developed (evaluated by transvaginal sonography), hCG (Choriomon, Switzerland) 5000 IU/2/IM is injected. About 34–36 after hCG injection, oocyte retrieval is performed
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Women General Hospital
Full name of responsible person
Dr. Azra Azmoodeh
Street address
Tehran Women General Hospital, Shomali Negatollahi St., Karim Khan Blvd., Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences
Full name of responsible person
Dr. Masud Yunesian
Street address
Floor 6th, Deputy of Research of Tehran University of Medical Sciences, Ghods St., Keshavarz Blvd.,Tehran
City
Tehran
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, Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Medicine faculty, Tehran University of Medical Sciences
Full name of responsible person
Dr. Fatemeh Sadat Hoseini
Position
Faculty Member, Assistant Professor
Other areas of specialty/work
Street address
Tehran Women General Hospital, Shomali Negatollahi St., Karim Khan Blvd., Tehran
City
Tehran
Postal code
Phone
+98 21 8890 7062
Fax
Email
fshoseini@farabi.tums.ac.ir; hoseini_fs@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Medicine Faculty, Tehran University of Medical Sciences
Full name of responsible person
Dr. Azra Azmoodeh
Position
Faculty Member, Assistant Professor
Other areas of specialty/work
Street address
Tehran Women General Hospital, Shomali Negatollahi St., Karim Khan Blvd., Tehran
City
Tehran
Postal code
Phone
+98 21 8890 7062
Fax
Email
Azraazmoodeh@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Medicine faculty, Tehran University of Medical Sciences
Full name of responsible person
Dr. Fatemeh Sadat Hoseini
Position
Faculty Member, Assistant Professor
Other areas of specialty/work
Street address
Tehran Women General Hospital, Shomali Negatollahi St., Karim Khan Blvd., Tehran
City
Tehran
Postal code
Phone
+98 21 8890 7062
Fax
Email
fshoseini@farabi.tums.ac.ir; hoseini_fs@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)