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Trial · Interventional

CompletedPhase 4Registry data

Luteal Phase FSH in the IVF Poor Responder

NCTNCT00225433 (opens ClinicalTrials.gov in a new tab)Other id803515Other idRRU013
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Overview

Status
Completed
Phase
Phase 4
Enrollment
20 participants (actual)
Sponsor
University of Pennsylvania · Other
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
Sept 2005
Primary completion
Dec 2006
Completion
Jun 2008
First posted
23 Sept 2005 (estimated)
Last update posted
3 Dec 2015 (estimated)
Conditions
Infertility

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20052006200720082009
  1. Ph 4

    Luteal Phase FSH in the IVF Poor Responder

    NCT00225433

    Sept 2005 to Jun 2008

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • follitropin betaDrug
  • ganirelix acetateDrug

Arms2

  • Active comparator

    1

    Follitropin beta

  • Active comparator

    2

    Ganirelix acetate

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Number of oocytes retrieved for IVF

    Time frame · One cycle

Secondary outcomes(6)

  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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Female
Age
from 20 Years up to 42 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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