NCT02352597

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2013

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

January 25, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 2, 2015

Completed
Last Updated

March 24, 2017

Status Verified

March 1, 2017

Enrollment Period

2 years

First QC Date

January 25, 2015

Last Update Submit

March 22, 2017

Conditions

Polycystic Ovaries

Keywords

PCOSPhytoestrogensovulation induction

Outcome Measures

Primary Outcomes (1)

  • endometrial thickness

    day 14 of menstrual cycle

Study Arms (3)

clomiphene citrate

ACTIVE COMPARATOR

only50 mg orally every 8 hours started from cycle day 3 for 5 days

Drug: clomiphene citrate

estradiol valerate and CC

ACTIVE COMPARATOR

2mg estradiol valerate orally daily from cycle day 7 - 11 in addition to CC

Drug: estradiol valerateDrug: clomiphene citrate

Phytoestrogen and CC

ACTIVE COMPARATOR

20mg of cimifuga racemosaorally from day 1- 12) in addition to CC

Drug: phytoestrogenDrug: clomiphene citrate

Interventions

phytoestrogenDRUG

20mg of cimifuga racemosa from day 1- 12

Also known as: Klimadynon
Phytoestrogen and CC
estradiol valerateDRUG

2mg from cycle day 7 to day 11

Also known as: cycloprogynova
estradiol valerate and CC
clomiphene citrateDRUG

50 mg orally every 8 hours started from cycle day 3 for 5 days

Also known as: clomid
Phytoestrogen and CCclomiphene citrateestradiol valerate and CC

Eligibility Criteria

Age20 Years - 37 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women with both 1ry and 2ry infertility were included. All women were between 20 and 37 years old.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

PhytoestrogensKlimadynonEstradiolClomiphene

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Estrogens, Non-SteroidalEstrogensHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesEstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic CompoundsEstradiol CongenersGonadal Steroid HormonesGonadal HormonesStilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Ahmed Maged, MD

    Kasr Alainy medical school

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

January 25, 2015

First Posted

February 2, 2015

Study Start

January 1, 2013

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

March 24, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share