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the Effect of Clomiphene Citrate Plus Estradiol Valerate Versus Letrozole on Endometrial Thickness and Pregnancy Rate in Infertile Women

Primary Purpose

Endometrial Thickness, Pregnancy Rate

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Clomid; Aventis pharma S.AE, Global Napi pharmaceuticals, Cairo, Egypt
letrozole (Femara; Novartis pharma AG, Basle, Switzerland)
Sponsored by
Laylay Mohammed Khalleefah Alhibshi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometrial Thickness focused on measuring Letrozole, clomiphene Citrate, PCOS, Endometrial thickness

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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).

Sites / Locations

  • Faculty of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group A (clomiphene citrate & estradiol group)

Group B (Letrozole group)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

the ovulation rate
The number of follicles that mature and ovulate during a given menstrual or estrous cycle is referred to as ovulation rate or quota.

Full Information

First Posted
November 2, 2020
Last Updated
November 5, 2020
Sponsor
Laylay Mohammed Khalleefah Alhibshi
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1. Study Identification

Unique Protocol Identification Number
NCT04619914
Brief Title
the Effect of Clomiphene Citrate Plus Estradiol Valerate Versus Letrozole on Endometrial Thickness and Pregnancy Rate in Infertile Women
Official Title
Comparison of the Effect of Clomiphene Citrate Plus Estradiol Valerate Versus Letrozole on Endometrial Thickness and Pregnancy Rate in Infertile Women With Polycystic Ovarian Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
July 1, 2019 (Actual)
Study Completion Date
August 10, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Laylay Mohammed Khalleefah Alhibshi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
Detailed Description
Polycystic Ovarian Syndrome (PCOS) is the most common endocrine disorder in infertile women. Infertility affects 40% of women with PCOS. Understanding the main causes of infertility and selecting an appropriate treatment plan is a diagnostic and therapeutic priority The aim of this work was to compare the effect of Clomiphene citrate plus Estradiol Valerate versus Letrozole on endometrial thickness and pregnancy rate in infertile PCOS women underwent ovulation induction The study was designed as a randomized double blind study using a computer-generated randomization list and sequentially numbered opaque sealed envelopes, each containing the allocation information written on a card. Envelopes were opened sequentially by a study nurse to allocate patients to the assigned group. These patients were divided into two groups: Group A (clomiphene citrate & estradiol group): 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. Group B (Letrozole group): included 35 anovulatory PCO patients who received letrozole (Femara; Novartis pharma AG, Basle, Switzerland) 5 mg daily from cycle day 3 to day 7.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Thickness, Pregnancy Rate
Keywords
Letrozole, clomiphene Citrate, PCOS, Endometrial thickness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A (clomiphene citrate & estradiol group)
Arm Type
Experimental
Arm Description
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
Arm Title
Group B (Letrozole group)
Arm Type
Experimental
Arm Description
included 35 anovulatory PCO patients who received letrozole (Femara; Novartis pharma AG, Basle, Switzerland) 5 mg daily from cycle day 3 to day 7.
Intervention Type
Drug
Intervention Name(s)
Clomid; Aventis pharma S.AE, Global Napi pharmaceuticals, Cairo, Egypt
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
letrozole (Femara; Novartis pharma AG, Basle, Switzerland)
Intervention Description
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.
Primary Outcome Measure Information:
Title
the endometrial thickness
Description
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
Time Frame
up to 24 weeks
Secondary Outcome Measure Information:
Title
the ovulation rate
Description
The number of follicles that mature and ovulate during a given menstrual or estrous cycle is referred to as ovulation rate or quota.
Time Frame
up to 24 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients aged 18-35 years old with complete infertility workup patients diagnosed as having PCOs women Normal semen analysis Exclusion Criteria: 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abdel-Mageed M Sarhan, MD
Organizational Affiliation
Zagazig University
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of Medicine
City
Zagazig
State/Province
Sharkia
ZIP/Postal Code
23451
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

the Effect of Clomiphene Citrate Plus Estradiol Valerate Versus Letrozole on Endometrial Thickness and Pregnancy Rate in Infertile Women

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