Ignite Creation Date:
2024-05-06 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 12:51 PM
Study NCT ID:
NCT03619707
Status:
COMPLETED
Last Update Posted:
2023-07-20
First Post:
2018-08-03
Brief Title:
Oral Versus Vaginal Progesterone in the Luteal Support in Cryo-warmed Embryo Transfer Cycles
Sponsor:
American University of Beirut Medical Center
Organization:
American University of Beirut Medical Center
Study Overview
Official Title:
Oral Dydrogesterone Versus Vaginal Progesterone in the Luteal Phase Support in Cryo-warmed Embryo Transfer Cycles Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2023-07
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:
In IVFICSI cycles the progesterone levels induced by ovarian stimulation are low therefore the luteal phase is supported by progesterone The use of progestogens in IVF is associated with an improvement in the live birth rate Standard protocol for luteal phase support has not yet been established Currently vaginal progesterone is widely used since the classic oral progesterone seems to result in a low bioavailability and a lower pregnancy rate However vaginal administration of progesterone is associated with vaginal irritation discharge and bleeding For all these reasons there is a need for an effective well tolerated and safe treatment that can improve patient satisfaction and compliance
Many studies have observed similar pregnancy rate results with dydrogesterone and micronized vaginal progesterone A new RCT including a total of 1143 patients by Tournaye showed that dydrogesterone treatment had a similar safety profile to micronized vaginal progesterone MVP for luteal support as part of ART treatment The crude pregnancy rates at 12 weeks were 376 and 331 in the dydrogesterone and MVP treatment groups respectively
Regarding the administration route of progesterone intramuscular and transvaginal routes are the two conventional progesterone administration techniques However very few studies have compared the advantages of oral dydrogestrone with vaginal progesterone for luteal support in ART cycles
The objective of the investigators study is to demonstrate the superiority of oral dydrogesterone Duphaston 10 over MVP Utrogestan used for luteal supplementation in cryo-warmed embryo transfer cycles Upon consent 224 patients women will be randomly allocated into either one of the study groups using a simple randomization method by computer-generated random numbers Group I will receive the oral dydrogesterone while group II will receive the vaginal microprogesterone
Many studies have observed similar pregnancy rate results with dydrogesterone and micronized vaginal progesterone A new RCT including a total of 1143 patients by Tournaye showed that dydrogesterone treatment had a similar safety profile to micronized vaginal progesterone MVP for luteal support as part of ART treatment The crude pregnancy rates at 12 weeks were 376 and 331 in the dydrogesterone and MVP treatment groups respectively
Regarding the administration route of progesterone intramuscular and transvaginal routes are the two conventional progesterone administration techniques However very few studies have compared the advantages of oral dydrogestrone with vaginal progesterone for luteal support in ART cycles
The objective of the investigators study is to demonstrate the superiority of oral dydrogesterone Duphaston 10 over MVP Utrogestan used for luteal supplementation in cryo-warmed embryo transfer cycles Upon consent 224 patients women will be randomly allocated into either one of the study groups using a simple randomization method by computer-generated random numbers Group I will receive the oral dydrogesterone while group II will receive the vaginal microprogesterone
Detailed Description:
None
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?:
False
Is an FDA AA801 Violation?:
None