etrozole for endometrial preparation in frozen embryo transfer

Phase 3

Conditions: N97.0
Condition 1: Polycystic ovarian syndrome. Condition 2: Implantation of embryo.
Polycystic ovarian syndrome
Female infertility associated with anovulation
E28.2

Registration Number: IRCT20080831001141N38

Lead Sponsor: Royan Institute

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: Female

Target Recruitment: 250

Inclusion Criteria

Diagnosis of polycystic ovary syndrome (PCOS) based on Rotterdam criteria
Women's age between 20-39 years
Body mass index (BMI) ranging from 18 to 30 kg/m2
Having at least 3 good quality frozen embryos in the cleavage stage to nominate for blastocyst embryo transfer
Patient consent to participate in the study

Exclusion Criteria

Patients with severe male infertility (sperm extraction with TESE, PESA method)
The treatment cycles with preimplantation genetic diagnosis (PGD) indication, use of donated oocyte or embryo, and use of surrogate uterus
Patients with moderate to severe endometriosis and unilateral or bilateral endometrioma and/or untreated hydrosaplpinx
Uterine infertility factor (congenital uterine abnormality except for treated uterine septum, intrauterine adhesions, diagnosis of generalized adenomyosis), history of uterine surgery (myomectomy) as well as the presence of submucosal and intramural fibroids or the presence of uterine polyps
Patients with a history of recurrent miscarriage (= 2 abortions )
Repeated implantation failure
Women with diabetes mellitus, uncontrolled thyroid disease and hypertension diagnosis

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical pregnancy rate. Timepoint: 6 - 7 weeks after embryos transfer. Method of measurement: The presence of a gestational sac with fetal heartbeat on the vaginal ultrasound.

Secondary Outcome Measures