Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06367712
Status:
COMPLETED
Last Update Posted:
2024-04-16
First Post:
2024-04-09
Brief Title:
Letrozole Alone Protocol Versus Using Letrozole and HCG Protocol
Sponsor:
Egymedicalpedia
Organization:
Egymedicalpedia
Study Overview
Official Title:
The Effect of Using Letrozole Alone Protocol Versus Using Letrozole and HCG Protocol on Induction of Ovulation in Polycystic Ovarian Syndrome Patients A Prospective Cohort Study
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Letrozole is a chemical compound CGS 20267 which is a third-generation nonsteroidal aromatase inhibitor
Letrozole blocks estrogen synthesis by directly affecting the hypothalamic-pituitary-ovarian axis subsequently increases gonadotropins which increase pregnancy rates Possible positive outcomes of aromatase inhibitors over selective estrogen-receptor modulators include a more physiologic hormonal stimulation of the endometrium which increases receptivity a lower multiple-pregnancy through single follicle growth a lesser side-effect especially vasomotor and mood symptoms and more prompt clearance from blood hence reducing the probabilities of periconceptional exposure
Letrozole blocks estrogen synthesis by directly affecting the hypothalamic-pituitary-ovarian axis subsequently increases gonadotropins which increase pregnancy rates Possible positive outcomes of aromatase inhibitors over selective estrogen-receptor modulators include a more physiologic hormonal stimulation of the endometrium which increases receptivity a lower multiple-pregnancy through single follicle growth a lesser side-effect especially vasomotor and mood symptoms and more prompt clearance from blood hence reducing the probabilities of periconceptional exposure
Detailed Description:
The first pilot study for the clinical use of letrozole for ovarian induction in polycystic ovary syndrome PCOS patients was done in 2000
In large randomized study letrozole was superior to clomiphene as a treatment for anovulatory infertility in women with the polycystic ovary syndrome Letrozole was also associated with higher live-birth and ovulation rates
Ovulation induction with letrozole is associated with an ovulation rate of 70-84 and a pregnancy rate of 20-27 per cycle
While in another study which Compare the Effect of Letrozole Alone with Letrozole Plus N-Acetylcysteine on Pregnancy Rate in Patients with Polycystic Ovarian Syndrome the pregnancy rate was 75 in letrozole alone group
Human chorionic gonadotropin HCG hormone will replace the naturally surging luteinizing hormone at mid-cycle subsequently will lead to full maturation of oocytes resulting in ovulation Additionally HCG will also enhance the endometrial quality by stimulating the corpus luteum HCG is a hormone that is produced mainly by the placental syncytiotrophoblasts cells it is also produced by other organs in minute amounts Liver colon and pituitary gland HCG main function is maintaining pregnancy through stimulating the corpus luteum to produce progesterone
This hormone is the cornerstone drug for inducing final maturation of follicles during a diversity of infertility treatment protocols
In order to diagnose Polycystic ovarian syndrome two out of three Rotterdam criteria should be present These criteria are chronic anovulation clinical andor biochemical evidence of hyperandrogenism and polycystic ovaries by ultrasound
incidence of PCOS from 6 to 21 when the ESHREASRM 2003 criteria were applied Infertility clinical definition is currently defined as 1 year of unwanted non-conception with unprotected intercourse in the fertile phase of the menstrual cycles
In large randomized study letrozole was superior to clomiphene as a treatment for anovulatory infertility in women with the polycystic ovary syndrome Letrozole was also associated with higher live-birth and ovulation rates
Ovulation induction with letrozole is associated with an ovulation rate of 70-84 and a pregnancy rate of 20-27 per cycle
While in another study which Compare the Effect of Letrozole Alone with Letrozole Plus N-Acetylcysteine on Pregnancy Rate in Patients with Polycystic Ovarian Syndrome the pregnancy rate was 75 in letrozole alone group
Human chorionic gonadotropin HCG hormone will replace the naturally surging luteinizing hormone at mid-cycle subsequently will lead to full maturation of oocytes resulting in ovulation Additionally HCG will also enhance the endometrial quality by stimulating the corpus luteum HCG is a hormone that is produced mainly by the placental syncytiotrophoblasts cells it is also produced by other organs in minute amounts Liver colon and pituitary gland HCG main function is maintaining pregnancy through stimulating the corpus luteum to produce progesterone
This hormone is the cornerstone drug for inducing final maturation of follicles during a diversity of infertility treatment protocols
In order to diagnose Polycystic ovarian syndrome two out of three Rotterdam criteria should be present These criteria are chronic anovulation clinical andor biochemical evidence of hyperandrogenism and polycystic ovaries by ultrasound
incidence of PCOS from 6 to 21 when the ESHREASRM 2003 criteria were applied Infertility clinical definition is currently defined as 1 year of unwanted non-conception with unprotected intercourse in the fertile phase of the menstrual cycles
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None