Phytoestrogens as an Alternative to Estradiol in Ovulation Induction in PCOS

Phase 4

Completed

• Conditions: Polycystic Ovaries
• Interventions: Drug: phytoestrogen; Drug: clomiphene citrate; Drug: estradiol valerate

• Registration Number: NCT02352597
• Lead Sponsor: Cairo University

Brief Summary

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.

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.

Study Timeline

• Study Start: 2013-01
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Study First Submitted: 2015-01-25
• Study First Submitted QC: 2015-01-30
• Study First Posted: 2015-02-02
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-22
• Last Update Posted: 2017-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
endometrial thickness	day 14 of menstrual cycle