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

N/ACompletedNCT04619914

Laylay Mohammed Khalleefah Alhibshi160 enrolled

Overview

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

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: 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

160

Conditions

Endometrial Thickness Pregnancy Rate

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)

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 35 Years

Medical Language ↔ Plain English

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).

Locations (1)

Faculty of Medicine

Zagazig, Sharqia Province, Egypt

Outcomes

Primary Outcomes

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

Time frame: up to 24 weeks

Secondary Outcomes

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.

Time frame: up to 24 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.