Luteal Phase FSH in the IVF Poor Responder

• ClinicalTrials.gov Identifier: NCT00225433
• Recruitment Status: Completed
• First Posted: September 23, 2005
• Last Update Posted: December 3, 2015
• Sponsor: University of Pennsylvania
• Information provided by (Responsible Party): University of Pennsylvania

Study Description

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

Study Design

• 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

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 1; Follitropin beta	Drug: follitropin beta; Follitropin beta
Active Comparator: 2; Ganirelix acetate	Drug: ganirelix acetate; Ganirelix acetate

Outcome Measures

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 ]

Eligibility Criteria

• 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

Contacts and Locations

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
• ClinicalTrials.gov Identifier: NCT00225433
• Other Study ID Numbers: 803515; RRU013
• First Posted: September 23, 2005
• Last Update Posted: December 3, 2015
• Last Verified: December 2015

Keywords provided by University of Pennsylvania:

infertility; in vitro fertilization

Additional relevant MeSH terms:

Infertility; Follicle Stimulating Hormone; Ganirelix; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Hormone Antagonists