NCT02344888

Brief Summary

The purpose of this study is to evaluate the effect of concomitant administration of prednisolone during use of clomiphene citrate (CC) for induction of ovulation in infertile lean women having CC resistant polycystic ovarian syndrome (PCOS).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Feb 2015

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 18, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 26, 2015

Completed
6 days until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

January 8, 2019

Status Verified

January 1, 2019

Enrollment Period

3.9 years

First QC Date

January 18, 2015

Last Update Submit

January 4, 2019

Conditions

InfertilityPolycystic Ovarian Syndrome

Keywords

PCOSClomiphene citrate resistantPrednisolone

Outcome Measures

Primary Outcomes (1)

  • Ovulation rate

    Number of ovulatory cycles divided by the number of stimulation cycles

    3 months

Secondary Outcomes (3)

  • Number of ovarian follicles ≥ 18 mm on day of HCG administration

    3 months

  • Endometrial thickness on day of HCG administration

    3 months

  • Clinical pregnancy rate

    6-8 weeks gestational age

Study Arms (2)

Clomiphene citrate-Prednisolone group

ACTIVE COMPARATOR

Women will receive clomiphene citrate and prednisolone

Drug: Clomiphene citrate and Prednisolone

Clomiphene citrate-placebo group

ACTIVE COMPARATOR

Women will receive clomiphene citrate and folic acid 0.5mg (placebo)

Drug: Clomiphene citrate and folic acid

Interventions

Clomiphene citrate and PrednisoloneDRUG

Women will receive clomiphene citrate (150 mg/day for 5 consecutive days from day 2 of the cycle) and prednisolone (5 mg/day for 10 consecutive days from day 2 of the cycle)

Also known as: Clomid and Hostacortin-H
Clomiphene citrate-Prednisolone group
Clomiphene citrate and folic acidDRUG

Women will receive clomiphene citrate alone (150 mg/day for 5 consecutive days from day 2 of the cycle) and folic acid (0.5 mg/day for 10 consecutive days from day 2 of the cycle)

Also known as: Clomid and folic acid
Clomiphene citrate-placebo group

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Infertile lean women with PCOS as defined by the Rotterdam criteria.
  • CC resistance (defined as failure of ovulation after receiving 150 mg/day of CC for 5 consecutive days per cycle, for at least 3 consecutive cycles).

You may not qualify if:

  • Age \< 20 or \> 35 years.
  • Body mass index (BMI) \< 18.5 kg/m2 or \> 25 kg/m2.
  • Presence of any infertility factor other than anovulatory PCOS.
  • Previous history of ovarian surgery or surgical removal of one ovary.
  • Previous exposure to cytotoxic drugs or pelvic irradiation.
  • Oral hypoglycemic or hormonal therapy either currently or in the preceding 3 months.
  • Metabolic or hormonal abnormalities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Obstetrics and Gynecology Department in Mansoura University Hospital

Al Mansurah, Dakahlia Governorate, 35111, Egypt

RECRUITING

Private practice settings

Al Mansurah, Dakahlia Governorate, Egypt

RECRUITING

MeSH Terms

Conditions

InfertilityPolycystic Ovary Syndrome

Interventions

ClomiphenePrednisoloneMethylprednisoloneFolic Acid

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital DiseasesOvarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

StilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Mahmoud M Abdelrazik, Dr

    Mansoura University

    PRINCIPAL INVESTIGATOR

  • Mahmoud Thabet, D

    Mansoura University

    STUDY DIRECTOR

Central Study Contacts

Mahmoud M Abdelrazik, Dr

CONTACT

+201005548881dr_mahmoudhosam@yahoo.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

January 18, 2015

First Posted

January 26, 2015

Study Start

February 1, 2015

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

January 8, 2019

Record last verified: 2019-01

Locations

EG(2)