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

NCT ID: NCT01465373

Last Updated: 2011-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2011-09-30

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.

Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Progesterone in Oil

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.

Group Type ACTIVE_COMPARATOR

Progesterone in Oil

Intervention Type DRUG

50 mg IM injection daily

Endometrin

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.

Group Type ACTIVE_COMPARATOR

Endometrin

Intervention Type DRUG

100 mg per vagina TID

Interventions

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Endometrin

100 mg per vagina TID

Intervention Type DRUG

Progesterone in Oil

50 mg IM injection daily

Intervention Type DRUG

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
Minimum Eligible Age

21 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ferring Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

Fertility Centers of Illinois

OTHER

Sponsor Role lead

Responsible Party

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Sue Jasulaitis, RN MS Clinical Research Coordinator

Angeline Beltsos, M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Angeline Beltsos, MD

Role: PRINCIPAL_INVESTIGATOR

Fertility Centers of Illinois

Locations

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Fertility Centers of Illinois

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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10-019

Identifier Type: -

Identifier Source: org_study_id