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Luteal Phase FSH in the IVF Poor Responder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00225433
Recruitment Status : Completed
First Posted : September 23, 2005
Last Update Posted : December 3, 2015
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Infertility Drug: follitropin beta Drug: ganirelix acetate Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Luteal Phase Recombinant FSH vs. Follicular Phase Recombinant FSH for IVF Stimulation in the Poor Responder
Study Start Date : September 2005
Actual Primary Completion Date : December 2006
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility

Arm Intervention/treatment
Active Comparator: 1
Follitropin beta
Drug: follitropin beta
Follitropin beta

Active Comparator: 2
Ganirelix acetate
Drug: ganirelix acetate
Ganirelix acetate




Primary Outcome Measures :
  1. Number of oocytes retrieved for IVF [ Time Frame: One cycle ]

Secondary Outcome Measures :
  1. Number of follicles >10mm on day of human chorionic gonadotropin (hCG) administration; [ Time Frame: 1 cycle ]
  2. Number of days of stimulation; [ Time Frame: 1 cycle ]
  3. Estradiol level on the day of hCG administration; [ Time Frame: 1 cycle ]
  4. Clinical pregnancy rate per transfer: defined as the presence of an intrauterine sac on transvaginal ultrasound; [ Time Frame: 1 cycle ]
  5. Delivery rate per transfer; [ Time Frame: 1 cycle ]
  6. Safety (incidence of ovarian torsion, severe risk of ovarian hyperstimulation syndrome, enlarging hemorrhagic cysts, and serious adverse events) [ Time Frame: 1 cycle ]


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Ages Eligible for Study:   20 Years to 42 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00225433


Locations
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United States, Pennsylvania
University of Pennsylvania Reproductive Research Unit
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Investigators
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Principal Investigator: Kurt T Barnhart, MD, MSCE University of Pennsylvania

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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00225433    
Other Study ID Numbers: 803515
RRU013
First Posted: September 23, 2005    Key Record Dates
Last Update Posted: December 3, 2015
Last Verified: December 2015
Keywords provided by University of Pennsylvania:
infertility
in vitro fertilization
Additional relevant MeSH terms:
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Infertility
Genital Diseases, Male
Genital Diseases, Female
Follicle Stimulating Hormone
Ganirelix
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Hormone Antagonists