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Vaginal Progesterone Versus Progesterone in Oil in Donor Egg Recipient In Vitro Fertilization Cycles Utilizing Vitrified Donor Eggs

Primary Purpose

Infertility

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Endometrin
Progesterone in Oil
Sponsored by
Fertility Centers of Illinois
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring In-Vitro Fertilization, Donor Egg IVF

Eligibility Criteria

21 Years - 49 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Fertility Centers of Illinois

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Progesterone in Oil

Endometrin

Arm Description

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.

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.

Outcomes

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

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.

Full Information

First Posted
May 5, 2010
Last Updated
November 2, 2011
Sponsor
Fertility Centers of Illinois
Collaborators
Ferring Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01465373
Brief Title
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

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fertility Centers of Illinois
Collaborators
Ferring Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
In-Vitro Fertilization, Donor Egg IVF

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Progesterone in Oil
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Endometrin
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Endometrin
Intervention Description
100 mg per vagina TID
Intervention Type
Drug
Intervention Name(s)
Progesterone in Oil
Intervention Description
50 mg IM injection daily
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angeline Beltsos, MD
Organizational Affiliation
Fertility Centers of Illinois
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fertility Centers of Illinois
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60610
Country
United States

12. IPD Sharing Statement

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Vaginal Progesterone Versus Progesterone in Oil in Donor Egg Recipient In Vitro Fertilization Cycles Utilizing Vitrified Donor Eggs

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