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

This study has been completed.
Sponsor:
Collaborator:
Ferring Pharmaceuticals
Information provided by (Responsible Party):
Sue Jasulaitis, RN MS Clinical Research Coordinator, Fertility Centers of Illinois
ClinicalTrials.gov Identifier:
NCT01465373
First received: May 5, 2010
Last updated: November 2, 2011
Last verified: November 2011
  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

Resource links provided by NLM:


Further study details as provided by Fertility Centers of Illinois:

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 [ Time Frame: 10-12 days post IVF-ET ] [ Designated as safety issue: No ]

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. [ 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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01465373

Locations
United States, Illinois
Fertility Centers of Illinois
Chicago, Illinois, United States, 60610
Sponsors and Collaborators
Fertility Centers of Illinois
Ferring Pharmaceuticals
Investigators
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 August 01, 2014