IVF
Conditions
Brief summary
In order to get optimal pregnancy rates after frozen embryo transfer (FET), the embryo stage and endometrium should be synchronized. Endometrial preparation is done by either natural, artificial (Hormonal replacement therapy HRT) , modified natural methods or mild ovarian stimulation. HRT cycle has a better schedualization however, there are some reports about higher rates of miscarriage, pregnancy induced hypertension (PIH) and preeclampsia (PET) in HRT cycles. A recent study has found that incorporation of the aromatase inhibitor (letrozole) to HRT cycles was associated with better FET outcomes in comparison to hormonal replacement therapy cycles alone. Meanwhile, mild ovarian stimulation protocol can be done either by oral drugs like letrozole or by letrozole plus gonadotropins . So this study aims to compare the reproductive outcomes in two endometrial preparation protocols for frozen embryo transfer cycles; letrozole mild ovarian stimulation versus HRT plus letrozole incorporation.
Detailed description
In order to get optimal pregnancy rates after frozen embryo transfer (FET), the embryo stage and endometrium should be synchronized. This can be done by hormonal replacement therapy (HRT), natural cycles (NC), modified natural cycles or mild ovarian stimulation. In hormonal replacement therapy cycle, estrogen and progesterone are sequentially given to resemble the hormonal course of the natural cycle . Hormonal replacement therapy cycle has a better schedualization and is used for patients with irregular cycles as polycystic ovary syndrome ( PCOS). However, there are some reports about higher rates of miscarriage, pregnancy induced hypertension (PIH) and preeclampsia (PET) in HRT cycles. A recent study has found that incorporation of the aromatase inhibitor (letrozole) to HRT cycles was associated with better FET outcomes in comparison to HRT cycles alone. Ongoing pregnancy rate (OPR) was higher in HRT plus letrozole group than HRT only group. Letrozole is a third-generation aromatase inhibitor that leads to mono-ovulatory cycles with short half-life . Miller and his colleagues found that letrozole increased Integrin expression and improved pregnancy and implantation rates among women with endometrial receptivity defects . Another study found that ovarian stimulation with letrozole was associated with increase in the expression of uterine receptivity markers including integrin, leukemia inhibitory factor, and L-selectin.
Interventions
DRUGestradiol valerate and letrozole
hormone replacement therapy by estradiol valerate plus letrozole incorporation .
DRUGletrozole 2,5 mg tablet
mild ovarian stimulation
Sponsors
Rahem Fertility Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 37 Years
Healthy volunteers
No
Inclusion criteria
* Women aged between 18 and 37 years with either regular cycles or oligomenorrhoea or amenorrhoea. * Women undergoing FET cycles. * Participants should have at least one good-quality blastocyst available for vitrification and also for transfer after warming. * Participants having optimal endometrium before starting luteal phase support
Exclusion criteria
* Women who will refuse to participate in in the study. * Women who will not reach the optimal endometrium. * Participants that don't have at least one good-quality blastocyst for transfer after warming. * PGT embryos will be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ongoing pregnancy rate (OPR) | 12 weeks | Number of pregnant women with viable fetus at 12 weeks gestation per woman randomized |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ectopic pregnancy | 7 week | pregnancy outside the uterine cavity diagnosed by ultrasound ,surgical visualization or histopathology |
| Miscarriage rate | 12 weeks | Number of miscarriages per woman with positive pregnancy tests |
| Implantation rate | 21 days after embryo transfer | Number of gestational sac recognized by ultrasound in uterus 3 weeks after embryo transfer |
| Clinical pregnancy rate (CPR) | 5 weeks after embryo transfer | Number of gestational sacs with evident fetal pulsations per woman randomized,ectopic pregnancy is also includded pregnancy is aslo included |
| Number of participants with Hypertensive disorders of pregnancy | 20 weeks gestation till postpartum | gestational hypertension or preeclampsia |
| Number of participants with Large for gestational age | from gestation till delivery | A birth weight greater than the 90th centile of the sex-specific birth weight for a given gestational age reference |
| live birth rate | 22 completed weeks of gestational age | The complete expulsion or extraction from a woman of a product of fertilization,after 22 complete weeks of gestational age;which,after such separation,breathes or shows any other evidence of life,such as heart beat,umblical cord pulsation or definite movement of voluntary muscles,irrespective of whether the umblical cord has been cut or the placenta is attached.A birth weight of 500 grams or more can be used if gestational age is unknown.Live births refer to the individual newborn ;for example,a twin delivery represents two live births |
Countries
Egypt
Contacts
Primary ContactNoha Moustafa El-hibishy, MSc
Backup ContactEman El-gindy, MD,PhD
Outcome results
None listed