Phytoestrogens as an Alternative to Estradiol in Ovulation Induction in PCOS

Polycystic Ovaries Clinical Trial

— PCOS  

Official title:

Phytoestrogens as an Alternative to Estradiol in Reversing the Antiestrogenic Effect of Clomid on Endometrium in Ovulation Induction in Cases of Polycystic Ovarian Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02352597
• Other study ID #: 222
• Status: Completed
• Phase: Phase 4
• First received: January 25, 2015
• Last updated: March 22, 2017
• Start date: January 2013
• Est. completion date: January 2015

Study information

• Verified date: March 2017
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 37 Years

Eligibility

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

Related Conditions & MeSH terms

• Polycystic Ovaries
• Polycystic Ovary Syndrome

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	endometrial thickness		day 14 of menstrual cycle