Clinical Trial of the Effect of Fennel and Estrogen Compared with Estrogen Alone on Duration of Endometrial Thickness to Reach 8 millimeters in Women with Indication for Fetus Donation
(1) Objective: To compare the effect of fennel and estrogen with estrogen alone on endometrial thickness
(2) Design: Randomized, not-blinded, not-placebo-controlled, single-center, exploratory trial
(3) Setting and conduct:
Participants: All women referred to Infertility Clinic at Fatemieh Hospital with the indication for fetus donation
Inclusion criteria: indication for fetus donation
Exclusion criteria: none
Sample size: 100 patients
(4) Intervention: All patients will receive low dose tablet of oral contraceptive from the third day of menstrual cycle until the 21st day. Then from day 14 to 28 one ampule of gonadotropin releasing hormone (Buserelin) 0.5 milliliter will be administered subcutaneously daily. On the day 28 all patients will receive oral tablets of estradiol valerate 6 milligrams/day. But the intervention group along with estradiol will receive fennel as herbal tea, made with 10 grams of fennel boiled with 50 milliliter water for 20 minutes. On the 30th day and then every 3 days transvaginal ultrasound will be done to measure endometrial thickness. During this period 0.2 milliliter Buserelin will be continued subcutaneously.
(5) The intervention time: from the 28th day of menstrual cycle until the endometrium reaches 8 millimeters in thickness
(6) Main outcome measure: number of days for endometrium to reach 8 millimeters in thickness
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014120210617N2
Registration date:2015-01-15, 1393/10/25
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-01-15, 1393/10/25
Registrant information
Name
morteza Sedaghat Kia
Name of organization / entity
zaums
Country
Iran (Islamic Republic of)
Phone
+98 54 1244 9540
Email address
morimedico@yahoo.com
Recruitment status
Recruitment complete
Funding source
Hamadan University of Medical Sciences
Expected recruitment start date
2014-05-22, 1393/03/01
Expected recruitment end date
2015-03-01, 1393/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical Trial of the Effect of Fennel and Estrogen Compared with Estrogen Alone on Duration of Endometrial Thickness to Reach 8 millimeters in Women with Indication for Fetus Donation
Public title
Effect of Fennel on endometrial thickness
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: all women with indication for fetus donation; giving written consent to inclusion
Exclusion criteria: none
Age
From 18 years old to 51 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
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
Hamadan University of Medical Sciences
Street address
Opposite Mardom Park, Shahid Fahmideh St, Pajouhesh Sq, Daneshgah Blvd
City
Hamadan
Postal code
Approval date
2014-05-17, 1393/02/27
Ethics committee reference number
/16/35/9/699پ
Health conditions studied
1
Description of health condition studied
female infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
The time for endometrium to reach 8 millimetes in thickness
Timepoint
30th day of menstrual cycle and then every 3 days until reaching 8 milliliters in thickness
Method of measurement
Counting days
Secondary outcomes
1
Description
Endometrial thickness
Timepoint
Thirtieth day of menstural cycle and then every 3 days
Method of measurement
Transvaginal ultrasound
Intervention groups
1
Description
Intervention group: patients will receive low dose tablet of oral contraceptive from the third day of menstrual cycle until the 21st day. Then from day 14 to 28 one ampule of gonadotropin releasing hormone (Buserelin) 0.5 milliliter will be administered subcutaneously daily. On the day 28 patients will receive oral tablets of estradiol valerate 6 milligrams/day and fennel as herbal tea, made with 10 grams of fennel boiled with 50 milliliter water for 20 minutes. On the 30th day and then every 3 days transvaginal ultrasound will be done to measure endometrial thickness. During this period 0.2 milliliter Buserelin will be continued subcutaneously.
Category
Treatment - Drugs
2
Description
Control group: patients will receive low dose tablet of oral contraceptive from the third day of menstrual cycle until the 21st day. Then from day 14 to 28 one ampule of gonadotropin releasing hormone (Buserelin) 0.5 milliliter will be administered subcutaneously daily. On the day 28 patients will receive oral tablets of estradiol valerate 6 milligrams/day (without fennel). On the 30th day and then every 3 days transvaginal ultrasound will be done to measure endometrial thickness. During this period 0.2 milliliter Buserelin will be continued subcutaneously.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemieh Teaching Hospital
Full name of responsible person
Mahnaz Yavangui
Street address
Pasdaran St
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Saed Bashirian
Street address
Opposite Mardom Park, Shahid Fahmideh St, Pajouhesh Sq, Daneshgah Blvd
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamadan 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
Hamadan University of Medical Sciences
Full name of responsible person
Sarah Nazari Valashedjerdi
Position
Resident in Obstetrics and Gynecology
Other areas of specialty/work
Street address
Opposite Mardom Park, Shahid Fahmideh St, Pajouhesh Sq, Daneshgah Blvd
City
Hamadan
Postal code
Phone
+98 81 1827 7459
Fax
Email
drsara_nazari@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Mahnaz Yavangui
Position
Specialist in obstetrics and gynecology, Subspecialty in female infertility
Other areas of specialty/work
Street address
Opposite Mardom Park, Shahid Fahmideh St, Pajouhesh Sq, Daneshgah Blvd
City
Hamadan
Postal code
Phone
+98 81 1827 7459
Fax
Email
yavangi@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Sarah Nazari Valashedjerdi
Position
Resident in obstetrics and gynecology
Other areas of specialty/work
Street address
Opposite Mardom Park, Shahid Fahmideh St, Pajouhesh Sq, Daneshgah Blvd
City
Hamadan
Postal code
Phone
00
Fax
Email
drsara_nazari@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)