Vaginal Progesterone Versus Progesterone in Oil in Donor Egg Recipient In Vitro Fertilization Cycles Utilizing Vitrified Donor Eggs
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Infertility |
Drug: Endometrin Drug: Progesterone in Oil |
Phase 4 |
| Study Type: | Interventional |
| 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 ]
| Enrollment: | 10 |
| Study Start Date: | February 2010 |
| Study Completion Date: | September 2011 |
| Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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. |
Drug: Endometrin
100 mg per vagina TID
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 21 Years to 49 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Oocyte Donors:
- 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
Exclusion Criteria:
Oocyte Donors:
- 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
Contacts and Locations| United States, Illinois | |
| Fertility Centers of Illinois | |
| Chicago, Illinois, United States, 60610 | |
| Principal Investigator: | Angeline Beltsos, MD | Fertility Centers of Illinois |
More Information
No publications provided
| Responsible Party: | Sue Jasulaitis, RN MS Clinical Research Coordinator, Angeline Beltsos, M.D., Fertility Centers of Illinois |
| ClinicalTrials.gov Identifier: | NCT01465373 History of Changes |
| Other Study ID Numbers: | 10-019 |
| Study First Received: | May 5, 2010 |
| Last Updated: | November 2, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Fertility Centers of Illinois:
|
In-Vitro Fertilization Donor Egg IVF |
Additional relevant MeSH terms:
|
Infertility Genital Diseases, Male Genital Diseases, Female Progesterone Progestins |
Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013