the Effect of Clomiphene Citrate Plus Estradiol Valerate Versus Letrozole on Endometrial Thickness and Pregnancy Rate in Infertile Women
NCT ID: NCT04619914
Last Updated: 2020-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
160 participants
INTERVENTIONAL
2019-03-01
2019-08-10
Brief Summary
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Detailed Description
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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:
1. 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.
2. 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
Clomid; Aventis pharma S.AE, Global Napi pharmaceuticals, Cairo, Egypt
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 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.
letrozole (Femara; Novartis pharma AG, Basle, Switzerland)
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.
Interventions
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Clomid; Aventis pharma S.AE, Global Napi pharmaceuticals, Cairo, Egypt
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)
letrozole (Femara; Novartis pharma AG, Basle, Switzerland)
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.
Eligibility Criteria
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Inclusion Criteria
* patients diagnosed as having PCOs women
* Normal semen analysis
Exclusion Criteria
* 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).
18 Years
35 Years
FEMALE
No
Sponsors
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Laylay Mohammed Khalleefah Alhibshi
OTHER_GOV
Responsible Party
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Laylay Mohammed Khalleefah Alhibshi
M.B.B.CH , Faculty of Medicine, Aljabal -Algharbi university - Libya
Principal Investigators
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Abdel-Mageed M Sarhan, MD
Role: STUDY_DIRECTOR
Zagazig University
Locations
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Faculty of Medicine
Zagazig, Sharqia Province, Egypt
Countries
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Other Identifiers
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ZU-IRB# 5057/19-12-2018
Identifier Type: -
Identifier Source: org_study_id