NCT04619914

Brief Summary

The present randomized double blind study has been carried out in Gynecology and Obstetrics Department, Faculty of Medicine, Zagazig university on 70 women were previously received clomiphene citrate alone as management of infertile anovulatory PCOS women, but giving improper endometrial thickness \< 7mm during the period from March 2019 to September 2019

Trial Health

87
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

March 1, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2019

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 2, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 6, 2020

Completed
Last Updated

November 6, 2020

Status Verified

November 1, 2020

Enrollment Period

4 months

First QC Date

November 2, 2020

Last Update Submit

November 5, 2020

Conditions

Endometrial ThicknessPregnancy Rate

Keywords

Letrozoleclomiphene CitratePCOSEndometrial thickness

Outcome Measures

Primary Outcomes (1)

  • the endometrial thickness

    Thickness was measured by placing electronic calipers on the outer walls of the endometrium at its widest diameter as seen in the longitudinal axis of the uterine body

    up to 24 weeks

Secondary Outcomes (1)

  • the ovulation rate

    up to 24 weeks

Study Arms (2)

Group A (clomiphene citrate & estradiol group)

EXPERIMENTAL

included 35 anovulatory PCO patients who received clomiphene citrate (Clomid; Aventis pharma S.AE, Global Napi pharmaceuticals, Cairo, Egypt) 100 mg daily from cycle day 3 to 7 with estradiol valerate 4-mg (two white tablets of cyclopregynova) from cycle day 8 to 14

Drug: Clomid; Aventis pharma S.AE, Global Napi pharmaceuticals, Cairo, Egypt

Group B (Letrozole group)

EXPERIMENTAL

included 35 anovulatory PCO patients who received letrozole (Femara; Novartis pharma AG, Basle, Switzerland) 5 mg daily from cycle day 3 to day 7.

Drug: letrozole (Femara; Novartis pharma AG, Basle, Switzerland)

Interventions

Clomid; Aventis pharma S.AE, Global Napi pharmaceuticals, Cairo, EgyptDRUG

CLOMID (clomiphene citrate tablets USP) is an orally administered, nonsteroidal, ovulatory stimulant designated chemically as 2-\[p-(2-chloro-1,2-diphenylvinyl)phenoxy\] triethylamine citrate (1:1)

Group A (clomiphene citrate & estradiol group)
letrozole (Femara; Novartis pharma AG, Basle, Switzerland)DRUG

Letrozole, or CGS 20267, is an oral non-steroidal type II aromatase inhibitor. It is a third generation aromatase inhibitor like exemestane and anastrozole, meaning it does not significantly affect cortisol, aldosterone, and thyroxine.

Group B (Letrozole group)

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • patients aged 18-35 years old with complete infertility workup
  • patients diagnosed as having PCOs women
  • Normal semen analysis

You may not qualify if:

  • Patients with male factor infertility, hyperprolactinemia, thyroid disorder.
  • Patients with any tubal pathology or uterine pathology.
  • Contraindication of ovulation induction, (Multiple ovarian cysts or allergy to inducing agent "clomid").
  • Known or suspected pelvic infection (PID).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine

Zagazig, Sharqia Province, 23451, Egypt

Location

MeSH Terms

Interventions

ClomipheneLetrozole

Intervention Hierarchy (Ancestors)

StilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsNitrilesTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Abdel-Mageed M Sarhan, MD

    Zagazig University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
M.B.B.CH , Faculty of Medicine, Aljabal -Algharbi university - Libya

Study Record Dates

First Submitted

November 2, 2020

First Posted

November 6, 2020

Study Start

March 1, 2019

Primary Completion

July 1, 2019

Study Completion

August 10, 2019

Last Updated

November 6, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)