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

Pregnancy Rate Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04619914
• Other study ID #: ZU-IRB# 5057/19-12-2018
• Status: Completed
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: August 10, 2019

Study information

• Verified date: November 2020
• Source: Zagazig University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: August 10, 2019
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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).

Related Conditions & MeSH terms

• Endometrial Thickness
• Infertility
• Pregnancy Rate

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Egypt	Faculty of Medicine	Zagazig	Sharkia

Sponsors (1)

Lead Sponsor	Collaborator
Laylay Mohammed Khalleefah Alhibshi

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	up to 24 weeks