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Luteal Phase FSH in the IVF Poor Responder

NCT ID: NCT00225433

Last Updated: 2015-12-03

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

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2008-06-30

Brief Summary

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In vitro fertilization (IVF) is a common procedure used to assist couples who have difficulty conceiving a pregnancy. IVF is a process where oocytes (eggs) are retrieved from a woman's ovaries and fertilized with sperm in the laboratory. In order to maximize the number of oocytes that can be retrieved, a women undergoes ovarian stimulation with recombinant follicle stimulating hormone (FSH). Typically 6-20 oocytes are retrieved, but in some cases there is a limited response to the stimulation, producing a limited number of oocytes. This is called poor ovarian response.

This study is designed to objectively compare two treatment regimens currently advocated in clinical practice, but never compared directly. The purpose is to assess ovarian response to starting treatment at the end of the preceding cycle may increase the number of developing oocytes.

Detailed Description

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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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1

Follitropin beta

Group Type ACTIVE_COMPARATOR

follitropin beta

Intervention Type DRUG

Follitropin beta

2

Ganirelix acetate

Group Type ACTIVE_COMPARATOR

ganirelix acetate

Intervention Type DRUG

Ganirelix acetate

Interventions

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follitropin beta

Follitropin beta

Intervention Type DRUG

ganirelix acetate

Ganirelix acetate

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Infertile women planning to undergo IVF
2. Poor ovarian response in most-recent previous IVF cycle within the past 18 months as defined by the following criteria:

A) \<5 dominant follicles day of hCG, B) \<5 oocytes retrieved, or C) cancellation of a previous IVF cycle due to poor response to ovulation stimulation.
3. Aged 20-42 (inclusive) at the time of randomization
4. Presence of both ovaries
5. Normal pap smear within past three years
6. At least 45 days after the last IVF cycle
7. Be willing and able to comply with the protocol for the duration of the study
8. Have given written informed consent, prior to any study-related procedure, not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.

Exclusion Criteria

1. Clinically significant systemic disease
2. Current regular cigarette smoking by patient report
3. Known to be positive for Human Immunodeficiency Virus
4. Any medical condition which, in the judgment of the investigator and sponsor, may interfere with the absorption, distribution, metabolism or excretion of the medications used
5. Abnormal, undiagnosed gynecological bleeding
6. Known allergy or hypersensitivity to human gonadotropin preparations
7. Simultaneous participation in another investigational drug or device trial
8. Subject fails, in 2 separate menstrual cycle attempts, to have FSH ≤12.0 and an ultrasound exam within normal limits (per standard for IVF) at the Baseline Visit
9. For subjects randomized to the Luteal Phase Regimen, failure to ovulate in 2 separate menstrual cycle attempts, as evidenced by ovulation predictor kit, progesterone level, and /or visualization of corpus luteum cyst on an ovary by ultrasound exam at the Luteal Visit
Minimum Eligible Age

20 Years

Maximum Eligible Age

42 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kurt T Barnhart, MD, MSCE

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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University of Pennsylvania Reproductive Research Unit

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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RRU013

Identifier Type: -

Identifier Source: secondary_id

803515

Identifier Type: -

Identifier Source: org_study_id