Infertility
Conditions
Brief summary
Traditionally, the use of GnRH-a suppression was considered essential for adequate endometrial hormonal modulation in cryopreserved-thawed embryo transfer cycles. Several studies, however, have questioned its necessity for controlled endometrial preparation. Using a high dose of estradiol from day 1 of the cycle will suppress the gonadotroph, preventing folliculogenesis and excessive secretion of LH, allowing adequate endometrial preparation without GnRH-a.
Interventions
PROCEDUREEmbryo transfer
The transfer of cryopreserved-thawed embryos inside the uterus aiming to achieve pregnancy
PROCEDURESerum Estradiol and Progesterone levels
Serum estradiol and serum progesterone levels in blood on the day of start of progesterone supplementation
DRUGGnRH agonist
GnRH agonist given on day 21 of the cycle preceding the embryo transfer
DRUGExternal Estradiol
Estradiol started on day1 of the cycle for endometrial prepartaion
DRUGProgesterone
progesterone as luteal phase support start after endometrium is well prepared
Sponsors
Nile Ivf Center, Cairo, Egypt
Kamal Shaeer center of infertility
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
* 20-35 years * BMI 20-30 * Regular menses. * No PCOS, no endometriosis * No uterine anomalies or lesions * No severe male factor * All grade 1 cleaved stage embryos
Exclusion criteria
* Less than 20 or more than 35 years * BMI less than 20 or more than 30 * Irregular cycles * PCOS or endometriosis * Uterine anomalies or lesions * Severe male factor * Poor quality embryos for transfer * Severe
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical pregnancy rate | 5 weeks after embryo transfer] | the detection of intrauterine gestational sac with positive pulsations |
| Live birth rate | 9 months | Pregnancy ending with a live birth |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of days needed for adequate (> 8mm) endometrial thickness | 12 to 20 days | Number of days on external hormones to prepare endometrium |
| Cycle cancellation: not related to thawing, thin endometrium, high P. OR related to embryos not surviving thawing. | 12 to 20 days | Cycle cancellation: not related to thawing, thin endometrium, high Progesterone. OR related to embryos not surviving thawing. |
| Chemical pregnancy rate | 14 days after embryo transfer | positive serum Beta HCG 14 days after embryo transfer |
| Estradiol and Progesterone levels on day of start of progesterone supplementation | 12 to 20 days | The serum levels of estradiol and progesterone before embryo transfer |
| Early miscarriage rate | 3 months | Pregnancy loss in the first 12 weeks gestation |
| Ongoing pregnancy rate | 3 months | Pregnancy ongoing beyond 12 weeks gestation |
| Implantation rate. | 5 weeks after embryo transfer | the ratio between the number of embryos transferred and the number of sacs |
| Endometrial thickness on day of start of progesterone supplementation | 12 to 20 days | The endometrial thickness on the day of starting progesterone supplementation to transfer the embryos |
Countries
Egypt
Outcome results
None listed