CompletedPhase 4ACTRN12614000785606

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


Sponsor

Ahmed Maged

Enrollment

150 participants

Start Date

Jan 1, 2013

Study Type

Interventional

Conditions

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


Eligibility

Sex: FemalesMin Age: 20 YearssMax Age: 37 Yearss

Inclusion Criteria2

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

Exclusion Criteria4

  • 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

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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 Na

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


Locations(1)

Cairo, Egypt

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