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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Infertility

Intervention / Treatment
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* Drug: Endometrin
* Drug: Progesterone in Oil


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Progesterone in Oil<br>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<br>* 50 mg IM injection daily<br>|
| Active Comparator: Endometrin<br>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<br>* 100 mg per vagina TID<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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In-Vitro Fertilization, Donor Egg IVF