Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000785606
Ethics application status
Approved
Date submitted
8/07/2014
Date registered
24/07/2014
Date last updated
24/07/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
can phytoestrogens replace estradiol in reversing the antiestrogenic effect of clomid in ovulation induction in cases of Poly cystic ovarian syndrome
Scientific title
phytoestrogens as an alternative to estradiol in reversing the antiestrogenic effect of clomid in ovulation induction in cases of PCOS
Secondary ID [1] 284939 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Infertility 292420 0
Condition category
Condition code
Reproductive Health and Childbirth 292735 292735 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
150 Patients were randomized at the beginning of each cycle by sealed opaque envelopes containing random generated numbers into three groups. All patients received clomiphene citrate (clomid global Napi , 6th October Egypt) 50 mg orally every 8 hours started from cycle day 3 for 5 days. Group 1 (50 patients) received no further treatment. Group 2 (50 patients) received estradiol valerate 2mg (cycloprogynova white tablets schering AG, Germany) from cycle day 7 to day 11. Group 3 (50 patients) received phytoestrogen (Klimadynon, Bionorica, Neumarkt i.d.OBf., Germany) (20mg of cimifuga racemosa from day 1to12). drug tablet return was used to monitor adherence to the intervention
Intervention code [1] 289770 0
Treatment: Drugs
Comparator / control treatment
clomiphene citrate 50 mg orally every 8 hours started from cycle day 3 for 5 days and estradiolvalerate 2mg from cycle day 7 to day 11 (group 2)
Control group
Active

Outcomes
Primary outcome [1] 292587 0
clinical pregnancy at 6 weeks gestation assessed by transvaginal ultrasound
Timepoint [1] 292587 0
14 days after missed period
Secondary outcome [1] 309268 0
ovulation rate assessed by transvaginal ultrasound
Timepoint [1] 309268 0
Day 16 of cycle

Eligibility
Key inclusion criteria
1. All participants had the diagnosis of polycystic ovarian syndrome (PCOS) based on presence of at least two of the following diagnostic criteria should be met: oligo/anovulation; clinical signs of hyperandrogenism (e.g., hirsutism and acne) and/or biochemical measurements; or enhanced polycystic ovaries and/or multiple discrete follicles in diameter in one ovary as detected by ultrasonography. The criteria fulfilling sufficient specificity and sensitivity to define PCO are the following: `presence of 12 or more follicles in each ovary measuring 2-9 mm in diameter, and/or increased ovarian volume (>10 cm3)

2. Women with both 1ry and 2ry infertility were included.

Minimum age
20 Years
Maximum age
37 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. women with endocrinological abnormalities as thyroid dysfunction or abnormal prolactin levels,
2. those with hypothalamic or pituitary dysfunctions evaluated by low gonadotropin level,
3. 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.
4. Women with ovarian cysts were also excluded from the study

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2013
Actual
1/01/2013
Date of last participant enrolment
Anticipated
30/04/2014
Actual
30/04/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment outside Australia
Country [1] 6204 0
Egypt
State/province [1] 6204 0
Cairo

Funding & Sponsors
Funding source category [1] 289567 0
Self funded/Unfunded
Name [1] 289567 0
Ahmed Maged
Country [1] 289567 0
Egypt
Primary sponsor type
Individual
Name
Ahmed Maged
Address
Kasr Aini medical school 135 king faisal street. postal code 12151
Country
Egypt
Secondary sponsor category [1] 288249 0
Individual
Name [1] 288249 0
Aly Abdelhafez
Address [1] 288249 0
Kasr Aini medical school. 425 Haram street. postal code 12155
Country [1] 288249 0
Egypt

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Objective: to study the effect of phytoestrogens as an alternative to estradiol in reversing the antiestrogenic effect of clomid in cases of PCOS
Methods: 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
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 49778 0
Dr Ahmed Maged
Address 49778 0
kasr Aini medical school. 135 king faisal street postal code 12151
Country 49778 0
Egypt
Phone 49778 0
+20201005227404
Fax 49778 0
Email 49778 0
prof.ahmedmaged@gmail.com
Contact person for public queries
Name 49779 0
Dr Ahmed Maged
Address 49779 0
kasr Aini medical school. 135 king faisal street postal code 12151
Country 49779 0
Egypt
Phone 49779 0
+20201005227404
Fax 49779 0
Email 49779 0
prof.ahmedmaged@gmail.com
Contact person for scientific queries
Name 49780 0
Dr Ahmed Maged
Address 49780 0
kasr Aini medical school. 135 king faisal street postal code 12151
Country 49780 0
Egypt
Phone 49780 0
+20201005227404
Fax 49780 0
Email 49780 0
prof.ahmedmaged@gmail.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.