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

Infertility Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01465373
• Other study ID #: 10-019
• Status: Completed
• Phase: Phase 4
• First received: May 5, 2010
• Last updated: November 2, 2011
• Start date: February 2010
• Est. completion date: September 2011

Study information

• Verified date: November 2011
• Source: Fertility Centers of Illinois
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 49 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• Endometrin
100 mg per vagina TID
• Progesterone in Oil
50 mg IM injection daily

Locations

Country	Name	City	State
United States	Fertility Centers of Illinois	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Fertility Centers of Illinois	Ferring Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		10-12 days post IVF-ET	No
Secondary	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.		six to eight weeks	No