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Completed

NCT Number: NCT01465373

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

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.

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

21 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Fertility Centers of Illinois

Chicago, Illinois, 60610, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endometrin

Drug

100 mg per vagina TID

Progesterone in oil

Drug

50 mg IM injection daily

Primary outcomes

  1. 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Fertility Centers of Illinois

Other

Collaborators

  • Ferring Pharmaceuticals

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Nov 4, 2011
Registry last updated
Nov 4, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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