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Letrozole for endometrial preparation in frozen embryo transfer

The effect of mild stimulation with letrozole for endometrial preparation in blastocyst frozen-thawed embryo transfer cycles in patients with polycystic ovary syndrome:a randomized clinical trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20080831001141N38
Enrollment
250
Registered
2021-09-20
Start date
2021-08-23
Completion date
Unknown
Last updated
2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention 1: Intervention group: The preparation of the endometrium will be done by using mild stimulation, in this way letrozole tablet (Femati®, Atipharmed company, Iran) will be prescribed from

Sponsors

Royan Institute
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 39 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Chemical pregnancy rate. Timepoint: 14-16 days after embryo transfer. Method of measurement: Positive pregnancy (ß-hCG) blood test.;Implantation rate. Timepoint: 4-6 weeks after embryo transfer. Method of measurement: It is calculated through the ratio of the number of gestational sacs observed in transvaginal ultrasound to the number of transferred embryos.;Blighted ovum rate. Timepoint: 6-8 weeks after embryo transfer. Method of measurement: A blighted ovum is defined as an anembryonic (no embryo) pregnancy and is a leading cause of early pregnancy failure or miscarriage and it is diagnosed by transvaginal ultrasonography.;Ectopic pregnancy rate. Timepoint: 6-8 weeks after embryo transfer. Method of measurement: Ectopic pregnancy is a pregnancy in which the fetus develops outside the uterus, typically in a fallopian tube, and it is diagnosed through vaginal ultrasound within 6 to 8 weeks after the embryo transfer.;Miscarriage rate. Timepoint: From the beginning of clinical pregnancy diagnosis to 20 weeks of pregnancy. Method of measurement: Loss of clinical pregnancy before 20 weeks of gestation confirmed by uterine ultrasound.;Live birth rate. Timepoint: 20 to 42 weeks of pregnancy. Method of measurement: A live birth is the complete expulsion or extraction from its mother of a product of conception, irrespective of the duration of pregnancy, which, after such separation, breathes or shows any other evidence of life, such as beating of the heart, pulsation of the umbilical cord, or any definite movement of voluntary muscles, whether or not the umbilical cord has been cut or the placenta is attached.;The rates of obstetrics complications including gestational diabetes, preeclampsia and preterm birth. Timepoint: 20 to 42 weeks of pregnancy. Method of measurement: Diagnosed cases of gestational diabetes, preeclampsia and preterm labor will be followed up and recorded by a gynecologist during pregnancy in all patients.;Neonatal outcomes. Timepoint: At birth and a wee

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr.Maryam Hafezi

Royan Institute

maryamhafezi90@yahoo.com+98 21 2356 2640

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026