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

Information source: Fertility Centers of Illinois
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Infertility

Intervention: Endometrin (Drug); Progesterone in Oil (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Fertility Centers of Illinois

Official(s) and/or principal investigator(s):
Angeline Beltsos, MD, Principal Investigator, Affiliation: Fertility Centers of Illinois

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: 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: 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.

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

Minimum age: 21 Years. Maximum age: 49 Years. Gender(s): Female.

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

Locations and Contacts

Fertility Centers of Illinois, Chicago, Illinois 60610, United States
Additional Information

Starting date: February 2010
Last updated: November 2, 2011

Page last updated: August 23, 2015

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