Clinical trial NCT04619914: 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
Overall status: COMPLETED
Phase: NA
Conditions: Endometrial Thickness
Pregnancy Rate
Keywords: Letrozole
clomiphene Citrate
PCOS
Endometrial thickness
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2020-11-06
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

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.

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).

Primary outcomes:
measure: the endometrial thickness
timeFrame: up to 24 weeks
Secondary outcomes:
measure: the ovulation rate
timeFrame: up to 24 weeks
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Faculty of Medicine
state: Sharkia
Study officials:
affiliation: Zagazig University
name: Abdel-Mageed M Sarhan, MD
role: STUDY_DIRECTOR
References: