Luteal Phase FSH in the IVF Poor Responder - Full Text View

Purpose

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 starting treatment at the end of the preceding cycle may increase the number of developing oocytes.

Condition	Intervention	Phase
Infertility	Drug: follitropin beta Drug: ganirelix acetate	Phase IV

MedlinePlus related topics:

Infertility

ChemIDplus related topics:

Follitropin beta Urofollitropin Follicle Stimulating Hormone Ganirelix acetate Ganirelix

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Official Title:	Luteal Phase Recombinant FSH vs. Follicular Phase Recombinant FSH for IVF Stimulation in the Poor Responder

Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:

Number of oocytes retrieved for IVF [ Time Frame: One cycle ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Number of follicles >10mm on day of human chorionic gonadotropin (hCG) administration; [ Time Frame: 1 cycle ] [ Designated as safety issue: No ]
Number of days of stimulation; [ Time Frame: 1 cycle ] [ Designated as safety issue: No ]
Estradiol level on the day of hCG administration; [ Time Frame: 1 cycle ] [ Designated as safety issue: No ]
Clinical pregnancy rate per transfer: defined as the presence of an intrauterine sac on transvaginal ultrasound; [ Time Frame: 1 cycle ] [ Designated as safety issue: No ]
Delivery rate per transfer; [ Time Frame: 1 cycle ] [ Designated as safety issue: No ]
Safety (incidence of ovarian torsion, severe risk of ovarian hyperstimulation syndrome, enlarging hemorrhagic cysts, and serious adverse events) [ Time Frame: 1 cycle ] [ Designated as safety issue: No ]

Enrollment:	20
Study Start Date:	September 2005
Study Completion Date:	June 2008
Primary Completion Date:	December 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Follitropin beta	Drug: follitropin beta Follitropin beta
2: Active Comparator Ganirelix acetate	Drug: ganirelix acetate Ganirelix acetate

Eligibility

Ages Eligible for Study:	20 Years to 42 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00225433

Locations


United States, Pennsylvania
	University of Pennsylvania Reproductive Research Unit
	Philadelphia, Pennsylvania, United States, 19104

Sponsors and Collaborators

University of Pennsylvania

Investigators


Principal Investigator:	Kurt T Barnhart, MD, MSCE	University of Pennsylvania

More Information

Responsible Party:	University of Pennsylvania ( Kurt T Barnhart, MD, MSCE )
Study ID Numbers:	803515, RRU013
First Received:	September 21, 2005
Last Updated:	July 21, 2008
ClinicalTrials.gov Identifier:	NCT00225433
Health Authority:	United States: Institutional Review Board