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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

phytoestrogens as an alternative to estradiol in reversing the antiestrogenic effect of clomid in ovulation induction in cases of PCOS

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12614000785606
Enrollment
150
Registered
2014-07-24
Start date
2013-01-01
Completion date
2014-04-30
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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

Interventions

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) rec

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

Sponsors

Ahmed Maged
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
20 Years to 37 Years
Healthy volunteers
No

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026