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

Fertility Centers of Illinois

Status and phase: Completed; Phase 4

Conditions: Infertility

Treatments: Drug: Endometrin; Drug: Progesterone in Oil

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01465373

10-019

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: Female

Ages: 21 to 49 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

Progesterone in Oil

Active Comparator group

Description:

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.

Treatment:

Drug: Progesterone in Oil

Endometrin

Active Comparator group

Description:

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.

Treatment:

Drug: Endometrin