Clinical trial NCT01465373: Vaginal Progesterone Versus Progesterone in Oil in Donor Egg Recipient In Vitro Fertilization Cycles Utilizing Vitrified Donor Eggs
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Infertility
Keywords: In-Vitro Fertilization
Donor Egg IVF
Lead sponsor: Fertility Centers of Illinois
Sponsor class: OTHER
Collaborators: name: Ferring Pharmaceuticals
First posted: 2011-11-04
Enrollment: 10
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 criteria: 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

Primary outcomes:
measure: 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
timeFrame: 10-12 days post IVF-ET
Secondary outcomes:
measure: 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.
timeFrame: six to eight weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Fertility Centers of Illinois
state: Illinois
Study officials:
affiliation: Fertility Centers of Illinois
name: Angeline Beltsos, MD
role: PRINCIPAL_INVESTIGATOR
References: