Effect of Endometrial Injury Before Frozen Embryo Transfer on Pregnancy Rate
endometrial injury
Enfermedades Urogenitales
+ Enfermedades Genitales
+ Infertilidad
Estudio de Tratamiento
Resumen
Fecha de inicio: 8 de marzo de 2017
Fecha en la que se inscribió al primer participante.Suitable women will be invited to participate in the study then a signed and informed consent will be obtained from them. When the patient's consent is obtained, they are to be included into the study. Data Collection: During first visit, all patients will undergo complete clinical examination and detailed medical history will be obtained. Each patient will have a Case Record Form (CRF) in which the following data will be recorded. * Patient number (according to the randomization schedule). * Age, BMI. * Past medical and surgical history. * Duration of infertility. Procedure: Endometrial injury: A single induced injury will be done on the posterior endometrium on day 7 of the transfer cycle by using modified Cook catheter Protocol for vitrification Embryos will first loaded with equilibrium solution containing7.5% ethylene glycol (EG) and 7.5% dimethyl sulphoxide (DSMO) (Sigma-Aldrich) for 5-10 minute at room temperature and then with vitrification solution containing 15% EG, 15% DSMO and 0.5 mol/L sucrose for 50-60 seconds at room temperature. After observed cellular shrinkage, embryos will quickly stored in liquid nitrogen (LN) for at least 2 months. At warming, embryos will removed from LN and embryos will exposed to thawing solution containing sucrose at 37°C temperature for 50-60 seconds and then embryos will sequentially incubated in diluents solutions before being transferred . Evaluation and transfer of thawed embryos After thawing, each embryo will evaluated twice, once immediately for the number of surviving blastomeres and again after 18 hours post-thaw in vitro culture for assessing of mitosis and number of blastomeres. Embryos will considered survived if >50% of each blastomere are intact and selected for intrauterine transfer (Depending on patients' embryos, 2 or 3 embryos will transferred). Embryos will classified as fully intact or excellent morphology (100% cells survived with <10% fragmentation) or good morphology (100% cells survived with 10%-20% fragmentation), partially damaged or poor morphology (≥50% cells survived with or without any fragmentation) and Degenerated embryos (<50% cells survived) .Only fully intact and partially damaged embryos will transferred. Degenerated or arrested embryos will not transferred. Protocol of endometrial preparation before Frozen Embryo Transfer (FET) : There are different protocols for FET cycles. That is true for both "natural cycle" FETs and for "hormone replacement cycle" frozen-thawed embryo transfers. We will use hormone replacement cycles because they have better success rates. However, some clinics offer a natural cycle FET approach. Success rates are higher with hormone replacement, or "controlled" FET cycles. Medicines and Drugs in a Frozen Embryo Transfer FET Cycle 1. Gonadotropin-Releasing Hormone agonist (such as Lupron) will be given, either midluteal (day 21) or overlapping with a birth control pill. 2. Down-regulation will be confirmed by ultrasound and blood tests. 3. Estradiol valerate 2 mg twice daily (orally) will start after the period. This dose may need to be increased after monitoring of the uterine lining thickness. 4. When the endometrium has a "good" thickness( > 8 mm), progesterone will be started (intramuscular shots, or a vaginal product). 5. Embryo transfer will be planned for 3-6 days later - depending on the stage of development of the embryos to be transferred. 6. Estrogen and progesterone will be continued in the luteal phase. 7. Pregnancy testing will be done 9-14 days after transfer - depending on the stage of development of the embryos replaced and the preferences of the fertility clinic. 8. If pregnant, estrogen and progesterone will be continued until about 10-15 weeks of pregnancy and then weaned off.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 50 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Mujer
Sexo biológico de los participantes elegibles para inscribirse.Hasta 40 Años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.Un solo grupo de intervención está designado en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
ExperimentalObjetivos del Estudio
Objetivos Primarios
Objetivos Secundarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene una ubicación
ART unit - Ain Shams university Matrnity Hospital
Cairo, EgyptAbrir ART unit - Ain Shams university Matrnity Hospital en Google Maps