Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Nile Ivf Center, Cairo, Egypt | OTHER |
| Kamal Shaeer center of infertility | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| With GnRHa | Active Comparator | Cryopreserved-thawed embryo transfer cycle, with endometrial preparation using GnRHa followed by external estradiol and progesterone. The GnRHa depot from will be given on day 21 of the preceding cycle, on day 1 of the transfer cycle, the patient will receive 6 mg/ day of estradiol followed up on day 12 of the cycle, if the endometrium is less than 8 mm, till day 15 of the cycle estradiol will be increased to 8 mg/day until 8 mm or more. Then, serum estradiol and progesterone levels are collected, and progesterone 800 mg vaginal suppository will be added and embryo transfer performed 2 to 3 days later. |
|
| Without GnRHa | Active Comparator | Cryopreserved-thawed embryo transfer cycle, with endometrial preparation using external estradiol and progesterone only. On day 1 of the transfer cycle, the patient will receive 6 mg/ day of estradiol and followed up on day 12 of the cycle, if the endometrium did not reach 8 mm, till day 15 of the cycle the dose will be increased to 8 mg/day until the endometrium is 8 or more mm. When the endometrium is ready, serum estradiol and progesterone levels are collected, then progesterone 800 mg vaginal suppository will be added and embryo transfer performed 2 to 3 days later. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Embryo transfer | Procedure | The transfer of cryopreserved-thawed embryos inside the uterus aiming to achieve pregnancy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical pregnancy rate | the detection of intrauterine gestational sac with positive pulsations | 5 weeks after embryo transfer] |
| Live birth rate | Pregnancy ending with a live birth | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Estradiol and Progesterone levels on day of start of progesterone supplementation | The serum levels of estradiol and progesterone before embryo transfer | 12 to 20 days |
| Endometrial thickness on day of start of progesterone supplementation |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Eman K Shaeer, MD | Cairo University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IVF centre, Obstetrics and Gynaecology Department, Cairo University Hospitals (Kasr EL Aini) | Cairo | 12411 | Egypt | |||
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D004624 | Embryo Transfer |
| D007987 | Gonadotropin-Releasing Hormone |
| D011374 | Progesterone |
| ID | Term |
|---|---|
| D027724 | Reproductive Techniques, Assisted |
| D012099 | Reproductive Techniques |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Serum Estradiol and Progesterone levels | Procedure | Serum estradiol and serum progesterone levels in blood on the day of start of progesterone supplementation |
|
| GnRH agonist | Drug | GnRH agonist given on day 21 of the cycle preceding the embryo transfer |
|
|
| External Estradiol | Drug | Estradiol started on day1 of the cycle for endometrial prepartaion |
|
|
| Progesterone | Drug | progesterone as luteal phase support start after endometrium is well prepared |
|
|
The endometrial thickness on the day of starting progesterone supplementation to transfer the embryos
| 12 to 20 days |
| Number of days needed for adequate (> 8mm) endometrial thickness | Number of days on external hormones to prepare endometrium | 12 to 20 days |
| Cycle cancellation: not related to thawing, thin endometrium, high P. OR related to embryos not surviving thawing. | Cycle cancellation: not related to thawing, thin endometrium, high Progesterone. OR related to embryos not surviving thawing. | 12 to 20 days |
| Chemical pregnancy rate | positive serum Beta HCG 14 days after embryo transfer | 14 days after embryo transfer |
| Implantation rate. | the ratio between the number of embryos transferred and the number of sacs | 5 weeks after embryo transfer |
| Early miscarriage rate | Pregnancy loss in the first 12 weeks gestation | 3 months |
| Ongoing pregnancy rate | Pregnancy ongoing beyond 12 weeks gestation | 3 months |
| Kamal Shaeer center of infertility |
| Giza |
| 12411 |
| Egypt |
| Nile IVF center | Giza | 12411 | Egypt |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D003339 | Corpus Luteum Hormones |
| D042341 | Gonadal Hormones |
| D045167 | Progesterone Congeners |
| D012739 | Gonadal Steroid Hormones |