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Phytoestrogens as an Alternative to Estradiol in Ovulation Induction in PCOS (PCOS)

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ClinicalTrials.gov Identifier: NCT02352597
Recruitment Status : Completed
First Posted : February 2, 2015
Last Update Posted : March 24, 2017
Sponsor:
Information provided by (Responsible Party):
Ahmed Maged, 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.

Condition or disease Intervention/treatment Phase
Polycystic Ovaries Drug: phytoestrogen Drug: estradiol valerate Drug: clomiphene citrate Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : January 2013
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015


Arm Intervention/treatment
Active Comparator: clomiphene citrate
only50 mg orally every 8 hours started from cycle day 3 for 5 days
Drug: clomiphene citrate
50 mg orally every 8 hours started from cycle day 3 for 5 days
Other Name: clomid

Active Comparator: estradiol valerate and CC
2mg estradiol valerate orally daily from cycle day 7 - 11 in addition to CC
Drug: estradiol valerate
2mg from cycle day 7 to day 11
Other Name: cycloprogynova

Drug: clomiphene citrate
50 mg orally every 8 hours started from cycle day 3 for 5 days
Other Name: clomid

Active Comparator: Phytoestrogen and CC
20mg of cimifuga racemosaorally from day 1- 12) in addition to CC
Drug: phytoestrogen
20mg of cimifuga racemosa from day 1- 12
Other Name: Klimadynon

Drug: clomiphene citrate
50 mg orally every 8 hours started from cycle day 3 for 5 days
Other Name: clomid




Primary Outcome Measures :
  1. endometrial thickness [ Time Frame: day 14 of menstrual cycle ]


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Ages Eligible for Study:   20 Years to 37 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02352597


Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: Ahmed Maged, MD Kasr Alainy medical school

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Responsible Party: Ahmed Maged, Assistant professor, Cairo University
ClinicalTrials.gov Identifier: NCT02352597     History of Changes
Other Study ID Numbers: 222
First Posted: February 2, 2015    Key Record Dates
Last Update Posted: March 24, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Ahmed Maged, Cairo University:
PCOS
Phytoestrogens
ovulation induction
Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Citric Acid
Sodium Citrate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Clomiphene
Enclomiphene
Zuclomiphene
Estradiol
Polyestradiol phosphate
Phytoestrogens
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents