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

NCT01465373 | Completed Phase 4

• 1 other identifier: 10-019
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Infertility

Keywords

In-Vitro Fertilization; Donor Egg IVF

Outcome Measures

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

  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.

  six to eight weeks

Study Arms (2)

Progesterone in Oil

ACTIVE COMPARATOR

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

Endometrin

ACTIVE COMPARATOR

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

Interventions

Endometrin DRUG

100 mg per vagina TID

Endometrin

Progesterone in Oil DRUG

50 mg IM injection daily

Progesterone in Oil

Eligibility Criteria

• Age: 21 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Oocyte Donors:
• Age 21-34 years of age
• BMI 18-34
• Normal ovarian reserve, defined as FSH \<10 and AFC \>10
• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Fertility Centers of Illinois: lead
• Ferring Pharmaceuticals: collaborator

Study Sites (1)

Fertility Centers of Illinois

Chicago, Illinois, 60610, United States

Location

MeSH Terms

Conditions

Infertility

Interventions

Progesterone; Oils

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corpus Luteum Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones; Lipids

Study Officials

• Angeline Beltsos, MD

  Fertility Centers of Illinois

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Angeline Beltsos, M.D.

Study Record Dates

• First Submitted: May 5, 2010
• First Posted: November 4, 2011
• Study Start: February 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: November 4, 2011

Record last verified: 2011-11

Locations

US (1)