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

November 2, 2011 updated by: Sue Jasulaitis, RN MS Clinical Research Coordinator, Fertility Centers of Illinois

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60610
        • Fertility Centers of Illinois

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 47 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
10-12 days post IVF-ET

Secondary Outcome Measures

Outcome Measure
Time Frame
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
six to eight weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fertility Centers of Illinois

Collaborators

Ferring Pharmaceuticals

Investigators

  • Principal Investigator: Angeline Beltsos, MD, Fertility Centers of Illinois

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

May 5, 2010

First Submitted That Met QC Criteria

November 2, 2011

First Posted (Estimate)

November 4, 2011

Study Record Updates

Last Update Posted (Estimate)

November 4, 2011

Last Update Submitted That Met QC Criteria

November 2, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-019

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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