Vaginal Progesterone Versus Progesterone in Oil in Donor Egg Recipient In Vitro Fertilization Cycles Utilizing Vitrified Donor Eggs
This study has been completed.
Information provided by (Responsible Party):
Sue Jasulaitis, RN MS Clinical Research Coordinator, Fertility Centers of Illinois
First received: May 5, 2010
Last updated: November 2, 2011
Last verified: November 2011
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.
Drug: Progesterone in Oil
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
||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
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
| Study Start Date:
| Study Completion Date:
| 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.
|Ages Eligible for Study:
||21 Years to 49 Years (Adult)
|Sexes Eligible for Study:
|Accepts Healthy Volunteers:
- Age 21-34 years of age
- BMI 18-34
- Normal ovarian reserve, defined as FSH <10 and AFC >10
- Medical evaluation consistent with FDA criteria for donor inclusion
Donor Oocyte Recipients
- Documented history of infertility requiring donor oocyte for optimal fertility potential
- Documentation of a normal uterine cavity by hysteroscopy, hysterosonogram, or HSG within 1 year of study screening
- Fresh or Frozen Sperm
- Abnormal ovarian reserve, defined as FSH <10, AFC>10, prior poor response to controlled ovarian hyper-stimulation(COHS)
- Failure to meet FDA criteria for donor approval (risk factor and medical evaluation)
- Previous history of poor response to COHS
Donor Oocyte Recipients:
- Uncontrolled hypothyroidism, hyperprolactinemia, or systemic disease that may interfere with study treatment
- Active thrombophlebitis or thromboembolic disorders, or a history of hormone associated thrombophlebitis or thromboembolic disorders
- Surgically aspirated sperm (TESE)
- 2 or more clinical pregnancy losses (excluding aneuploidy for previous autologous cycles)
- Clinically significant gynecologic pathology or uterine abnormality, such as submucosal fibroids > 5 cm, communicating hydrosalpinx, uncorrected uterine septum, undiagnosed vaginal bleeding, endometrial atypia, or any other condition that could adversely affect pregnancy outcomes
- History of 2 or more failed IVF donor cycles
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01465373
|Fertility Centers of Illinois
|Chicago, Illinois, United States, 60610 |
Fertility Centers of Illinois
||Angeline Beltsos, MD
||Fertility Centers of Illinois
||Sue Jasulaitis, RN MS Clinical Research Coordinator, Angeline Beltsos, M.D., Fertility Centers of Illinois
History of Changes
|Other Study ID Numbers:
|Study First Received:
||May 5, 2010
||November 2, 2011
Keywords provided by Sue Jasulaitis, RN MS Clinical Research Coordinator, Fertility Centers of Illinois:
Donor Egg IVF
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 21, 2017
Genital Diseases, Male
Genital Diseases, Female
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs