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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ANZCTR |
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Last refreshed on:
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13 January 2020 |
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Main ID: |
ACTRN12614000785606 |
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Date of registration:
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24/07/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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can phytoestrogens replace estradiol in reversing the antiestrogenic effect of clomid in ovulation induction in cases of Poly cystic ovarian syndrome
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Scientific title:
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phytoestrogens as an alternative to estradiol in reversing the antiestrogenic effect of clomid in ovulation induction in cases of PCOS |
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Date of first enrolment:
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01/01/2013 |
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Target sample size:
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150 |
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Recruitment status: |
Completed |
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URL:
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https://anzctr.org.au/ACTRN12614000785606.aspx |
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Study type:
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Interventional |
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Study design:
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Purpose: Treatment; Allocation: Randomised controlled trial;
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Phase:
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Phase 4
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Countries of recruitment
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Egypt
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Contacts
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Name:
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Dr Ahmed Maged
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Address:
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kasr Aini medical school. 135 king faisal street postal code 12151
Egypt |
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Telephone:
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+20201005227404 |
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Email:
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prof.ahmedmaged@gmail.com |
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Affiliation:
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Name:
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Dr Ahmed Maged
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Address:
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kasr Aini medical school. 135 king faisal street postal code 12151
Egypt |
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Telephone:
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+20201005227404 |
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Email:
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prof.ahmedmaged@gmail.com |
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Affiliation:
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Key inclusion & exclusion criteria
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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.
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
Age minimum:
20 Years
Age maximum:
37 Years
Gender:
Females
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Health Condition(s) or Problem(s) studied
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Infertility;
Infertility
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Reproductive Health and Childbirth - Fertility including in vitro fertilisation
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Intervention(s)
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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
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Primary Outcome(s)
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clinical pregnancy at 6 weeks gestation assessed by transvaginal ultrasound[14 days after missed period]
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Secondary Outcome(s)
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ovulation rate assessed by transvaginal ultrasound[Day 16 of cycle]
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Source(s) of Monetary Support
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Ahmed Maged
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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