NCT00225433

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2005

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

September 21, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 23, 2005

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

December 3, 2015

Status Verified

December 1, 2015

Enrollment Period

1.2 years

First QC Date

September 21, 2005

Last Update Submit

December 1, 2015

Conditions

Infertility

Keywords

infertilityin vitro fertilization

Outcome Measures

Primary Outcomes (1)

  • Number of oocytes retrieved for IVF

    One cycle

Secondary Outcomes (6)

  • Number of follicles >10mm on day of human chorionic gonadotropin (hCG) administration;

    1 cycle

  • Number of days of stimulation;

    1 cycle

  • Estradiol level on the day of hCG administration;

    1 cycle

  • Clinical pregnancy rate per transfer: defined as the presence of an intrauterine sac on transvaginal ultrasound;

    1 cycle

  • Delivery rate per transfer;

    1 cycle

  • +1 more secondary outcomes

Study Arms (2)

1

ACTIVE COMPARATOR

Follitropin beta

Drug: follitropin beta

2

ACTIVE COMPARATOR

Ganirelix acetate

Drug: ganirelix acetate

Interventions

follitropin betaDRUG

Follitropin beta

1
ganirelix acetateDRUG

Ganirelix acetate

2

Eligibility Criteria

Age20 Years - 42 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Infertile women planning to undergo IVF
  • 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.
  • Aged 20-42 (inclusive) at the time of randomization
  • Presence of both ovaries
  • Normal pap smear within past three years
  • At least 45 days after the last IVF cycle
  • Be willing and able to comply with the protocol for the duration of the study
  • 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.

You may not qualify if:

  • Clinically significant systemic disease
  • Current regular cigarette smoking by patient report
  • Known to be positive for Human Immunodeficiency Virus
  • 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
  • Abnormal, undiagnosed gynecological bleeding
  • Known allergy or hypersensitivity to human gonadotropin preparations
  • Simultaneous participation in another investigational drug or device trial
  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania Reproductive Research Unit

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Infertility

Interventions

follitropin betaganirelix

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Kurt T Barnhart, MD, MSCE

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2005

First Posted

September 23, 2005

Study Start

September 1, 2005

Primary Completion

December 1, 2006

Study Completion

June 1, 2008

Last Updated

December 3, 2015

Record last verified: 2015-12

Locations

US(1)