Vaginal Progesterone Versus Progesterone in Oil in Donor Egg Recipient In Vitro Fertilization Cycles Utilizing Vitrified Donor Eggs
The aim of this study is to evaluate both pharmaceutical therapy and advanced treatment techniques for infertile patients requiring in-vitro fertilization utilizing donor eggs.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Comparison of the Effectiveness of Micronized Vaginal Progesterone (Endometrin, Ferring) Vs. Progesterone in Oil for Luteal Phase Support in Donor Egg Recipient IVF Cycles Utilizing Previously Vitrified Donor Oocytes|
- Clinical pregnancy rate of micronized vaginal progesterone (Endometrin, Ferring Pharmaceuticals) compared to intramuscular progesterone supplementation for luteal phase support after IVF-ET from previously vitrified donor eggs [ Time Frame: 10-12 days post IVF-ET ] [ Designated as safety issue: No ]
- Evaluation of the effectiveness of vitrification of IVF donor oocytes. Effectiveness will be evaluated by ooctye thaw/survival rates, fertilization and implantation rates assessed from the day of oocyte thawing through IVF cycle outcome. [ Time Frame: six to eight weeks ] [ Designated as safety issue: No ]
|Study Start Date:||February 2010|
|Study Completion Date:||September 2011|
|Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
Active Comparator: Progesterone in Oil
Donor egg recipients will begin progesterone 50 mg IM injection starting the day after donor egg fertilization, and continue daily until pregnancy results can be determined.
If pregnant, donor egg recipient will continue progesterone 50 mg IM injections daily until approximately 9 weeks of pregnancy.
Drug: Progesterone in Oil
50 mg IM injection daily
Active Comparator: Endometrin
Donor egg recipients will begin Endometrin 100 mg per vagina three times daily starting the day after donor egg fertilization and continue until pregnancy result can be determined.
If pregnant, donor egg recipients will continue Endometrin 100 mg TID until approximately 9 weeks of pregnancy.
100 mg per vagina TID
The primary objective of this study is to evaluate the clinical pregnancy rate of micronized progesterone (Endometrin, Ferring Pharmaceuticals) compared to progesterone in oil injections in in-vitro fertilization (IVF) donor egg recipients. The secondary objective is to evaluate the effectiveness of freezing/vitrification of donor eggs. Effectiveness of vitrification will be evaluated by egg thaw/survival, fertilization, and implantation rates.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01465373
|United States, Illinois|
|Fertility Centers of Illinois|
|Chicago, Illinois, United States, 60610|
|Principal Investigator:||Angeline Beltsos, MD||Fertility Centers of Illinois|