Phytoestrogens as an Alternative to Estradiol in Ovulation Induction in PCOS

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: January 2015

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.

Interventions

  • Drug: phytoestrogen
    • 20mg of cimifuga racemosa from day 1- 12
  • Drug: estradiol valerate
    • 2mg from cycle day 7 to day 11
  • Drug: clomiphene citrate
    • 50 mg orally every 8 hours started from cycle day 3 for 5 days

Arms, Groups and Cohorts

  • Active Comparator: clomiphene citrate
    • only50 mg orally every 8 hours started from cycle day 3 for 5 days
  • Active Comparator: estradiol valerate and CC
    • 2mg estradiol valerate orally daily from cycle day 7 – 11 in addition to CC
  • Active Comparator: Phytoestrogen and CC
    • 20mg of cimifuga racemosaorally from day 1- 12) in addition to CC

Clinical Trial Outcome Measures

Primary Measures

  • endometrial thickness
    • Time Frame: day 14 of menstrual cycle

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 20 Years

Maximum Age: 37 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Cairo University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ahmed Maged, Assistant professor – Cairo University
  • Overall Official(s)
    • Ahmed Maged, MD, Principal Investigator, Kasr Alainy medical school

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