Clinical trial comparison of the effect of capsule of date palm pollen with clomiphene citrate compared with clomiphene citrate only, on the levels of hormones in clomiphene citrate resistant infertile women with polycystic ovary syndrome
Goal: Evaluation of the effect of capsule of date palm pollen in infertile women with polycystic ovary syndrome.
Method: Randomly choose two groups including 50 women each, from day 5 to end of the cycle.
First group use clomiphene citrate with date palm pollen capsules. second group use placebo with clomiphene citrate. Level of fertility hormones will be checked before and during interventional on days 3 and 21 of cycle.
Primary outcome measure: Measurement of fertility hormones including gonadotropins(LH, FSH and their ratio), testosterone, progesterone and prolactin on days 3 and 21 of menstrual cycle.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017082016911N4
Registration date:2017-11-03, 1396/08/12
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-11-03, 1396/08/12
Registrant information
Name
Bahar Morshed Behbahani
Name of organization / entity
Shiraz Medical University
Country
Iran (Islamic Republic of)
Phone
+98 71 1630 1288
Email address
morshed_b@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shiraz University of Medical Sciences
Expected recruitment start date
2016-11-21, 1395/09/01
Expected recruitment end date
2017-07-23, 1396/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial comparison of the effect of capsule of date palm pollen with clomiphene citrate compared with clomiphene citrate only, on the levels of hormones in clomiphene citrate resistant infertile women with polycystic ovary syndrome
Public title
Evaluation of the effect of capsule of date palm pollen in infertile women with polycystic ovary syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Clomiphene Citrate resistant infertile women with polycystic ovary syndrome
Exclusion criteria: Having no desire to cooperate; Having allergy to date palm pollen; Interrupt treatment in ovulation period; Not using Clomiphene or date palm pollen capsule; allergic to date palm pollen; having chronic disease(Heart, respiratory, kidney and digestive diseases); using other herbal drugs that affect infertility
Age
From 20 years old to 40 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)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization with Blocked Randomization Method
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Zand st.
City
Shiraz
Postal code
713451978
Approval date
2016-10-09, 1395/07/18
Ethics committee reference number
IR.SUMS.REC.1395.119
Health conditions studied
1
Description of health condition studied
Polycystic ovary syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome
2
Description of health condition studied
Infertility due to PCO
ICD-10 code
N97.0
ICD-10 code description
Female infertility associated with anovulation
Primary outcomes
1
Description
Prolactine
Timepoint
Before and During intervention in Days 3 and 21 of cycle
Method of measurement
Blood Sample
2
Description
Progestrone
Timepoint
Before and During intervention in Days 3 and 21 of cycle
Method of measurement
Blood Sample
3
Description
Gonadotropines
Timepoint
Before and During intervention in Days 3 and 21 of cycle
Method of measurement
Blood Sample
4
Description
Testestrone
Timepoint
Before and During intervention in Days 3 and 21 of cycle
Method of measurement
Blood Sample
Secondary outcomes
empty
Intervention groups
1
Description
Date Palm pollen capsule, 2 grams daily from day 5 to end of the cycle and Clomiphene citrate, 150 ml grams daily from day 5 to 9 of the menstrual cycle.
Category
Treatment - Drugs
2
Description
Placebo 2 grams daily, from day 5 to the end of the cycle and Clomiphene citrate, 150 ml grams daily from day 5 to 9 of the menstrual cycle.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghadir mother and child hospital
Full name of responsible person
Maryam Alsadat Hadigheh
Street address
Golshan City, Quran gate, Shiraz
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research, Shiraz University of Medical Sciences
Full name of responsible person
Maryam Alsadat Hadigheh
Street address
Zand Street
City
Shiraz
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, Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Maryam Alsadat Hadigheh
Position
Midwife
Other areas of specialty/work
Street address
Namazi Square
City
Shiraz
Postal code
Phone
+98 71 3647 4255
Fax
Email
maryam.hadigheh@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Bahar Morshed Behbahani
Position
Masters
Other areas of specialty/work
Street address
Zand Street
City
Shiraz
Postal code
Phone
+98 71 3647 4255
Fax
Email
morshed_b@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Nursing and Midwifery Collage
Full name of responsible person
Maryam Alsadat Hadigheh
Position
midwife
Other areas of specialty/work
Street address
Nemazi Square
City
Shiraz
Postal code
Phone
+98 71 3647 4255
Fax
Email
maryam.hadigheh@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)