Back to resultsPhytoestrogens as an Alternative to Estradiol in Ovulation Induction in PCOS (PCOS)
Primary Purpose
Polycystic Ovaries
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
phytoestrogen
estradiol valerate
clomiphene citrate
Sponsored by
About this trial
This is an interventional treatment trial for Polycystic Ovaries focused on measuring PCOS, Phytoestrogens, ovulation induction
Eligibility Criteria
Inclusion Criteria:
Women with both 1ry and 2ry infertility were included. All women were between 20 and 37 years old.
Exclusion Criteria:
women with endocrinological abnormalities as thyroid dysfunction or abnormal prolactin levels, those with hypothalamic or pituitary dysfunctions evaluated by low gonadotropin level, other causes of infertility as tubal factor evaluated by HSG or laparoscopy, abnormal uterine cavity evaluated by sonohystrography or hysteroscopy and male factor evaluated by semen analysis. Women with ovarian cysts were also excluded from the study
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
clomiphene citrate
estradiol valerate and CC
Phytoestrogen and CC
Arm Description
only50 mg orally every 8 hours started from cycle day 3 for 5 days
2mg estradiol valerate orally daily from cycle day 7 - 11 in addition to CC
20mg of cimifuga racemosaorally from day 1- 12) in addition to CC
Outcomes
Primary Outcome Measures
endometrial thickness
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02352597
Brief Title
Phytoestrogens as an Alternative to Estradiol in Ovulation Induction in PCOS
Acronym
PCOS
Official Title
Phytoestrogens as an Alternative to Estradiol in Reversing the Antiestrogenic Effect of Clomid on Endometrium in Ovulation Induction in Cases of Polycystic Ovarian Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Prospective study conducted on 150 women with polycystic ovarian syndrome (PCOS) were randomly divided into 3 groups: group I (50 women) received clomiphene citrate (CC) only 50 mg orally every 8 hours started from cycle day 3 for 5 days, group II (50 women) received 2mg estradiol valerate daily from cycle day 7 - 11 in addition to CC and group III (50 women) received phytoestrogen (20mg of cimifuga racemosa from day 1- 12) in addition to CC.
Detailed Description
Prospective study conducted on 150 women with PCOS were randomly divided into 3 groups: group I (50 women) received CC only50 mg orally every 8 hours started from cycle day 3 for 5 days, group II (50 women) received 2mg estradiol valerate daily from cycle day 7 - 11 in addition to CC and group III (50 women) received phytoestrogen (20mg of cimifuga racemosa from day 1- 12) in addition to CC.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovaries
Keywords
PCOS, Phytoestrogens, ovulation induction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
clomiphene citrate
Arm Type
Active Comparator
Arm Description
only50 mg orally every 8 hours started from cycle day 3 for 5 days
Arm Title
estradiol valerate and CC
Arm Type
Active Comparator
Arm Description
2mg estradiol valerate orally daily from cycle day 7 - 11 in addition to CC
Arm Title
Phytoestrogen and CC
Arm Type
Active Comparator
Arm Description
20mg of cimifuga racemosaorally from day 1- 12) in addition to CC
Intervention Type
Drug
Intervention Name(s)
phytoestrogen
Other Intervention Name(s)
Klimadynon
Intervention Description
20mg of cimifuga racemosa from day 1- 12
Intervention Type
Drug
Intervention Name(s)
estradiol valerate
Other Intervention Name(s)
cycloprogynova
Intervention Description
2mg from cycle day 7 to day 11
Intervention Type
Drug
Intervention Name(s)
clomiphene citrate
Other Intervention Name(s)
clomid
Intervention Description
50 mg orally every 8 hours started from cycle day 3 for 5 days
Primary Outcome Measure Information:
Title
endometrial thickness
Time Frame
day 14 of menstrual cycle
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
37 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women with both 1ry and 2ry infertility were included. All women were between 20 and 37 years old.
Exclusion Criteria:
women with endocrinological abnormalities as thyroid dysfunction or abnormal prolactin levels, those with hypothalamic or pituitary dysfunctions evaluated by low gonadotropin level, other causes of infertility as tubal factor evaluated by HSG or laparoscopy, abnormal uterine cavity evaluated by sonohystrography or hysteroscopy and male factor evaluated by semen analysis. Women with ovarian cysts were also excluded from the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Maged, MD
Organizational Affiliation
Kasr Alainy medical school
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Phytoestrogens as an Alternative to Estradiol in Ovulation Induction in PCOS
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