Phytoestrogens as an Alternative to Estradiol in Ovulation Induction in PCOS

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Polycystic Ovaries

Intervention / Treatment
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* Drug: phytoestrogen
* Drug: estradiol valerate
* Drug: clomiphene citrate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 37 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: clomiphene citrate<br>only50 mg orally every 8 hours started from cycle day 3 for 5 days | Drug: clomiphene citrate<br>* 50 mg orally every 8 hours started from cycle day 3 for 5 days<br>* Other names: clomid;|
| Active Comparator: estradiol valerate and CC<br>2mg estradiol valerate orally daily from cycle day 7 - 11 in addition to CC | Drug: estradiol valerate<br>* 2mg from cycle day 7 to day 11<br>* Other names: cycloprogynova;Drug: clomiphene citrate<br>* 50 mg orally every 8 hours started from cycle day 3 for 5 days<br>* Other names: clomid;|
| Active Comparator: Phytoestrogen and CC<br>20mg of cimifuga racemosaorally from day 1- 12) in addition to CC | Drug: phytoestrogen<br>* 20mg of cimifuga racemosa from day 1- 12<br>* Other names: Klimadynon;Drug: clomiphene citrate<br>* 50 mg orally every 8 hours started from cycle day 3 for 5 days<br>* Other names: clomid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| endometrial thickness |  | day 14 of menstrual cycle | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PCOS, Phytoestrogens, ovulation induction