Luteal Phase FSH in the IVF Poor Responder

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00225433
• Other study ID #: 803515
• Secondary ID: RRU013
• Status: Completed
• Phase: Phase 4
• First received: September 21, 2005
• Last updated: December 1, 2015
• Start date: September 2005
• Est. completion date: June 2008

Study information

• Verified date: December 2015
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2008
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 42 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• follitropin beta
Follitropin beta
• ganirelix acetate
Ganirelix acetate

Locations

Country	Name	City	State
United States	University of Pennsylvania Reproductive Research Unit	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of oocytes retrieved for IVF		One cycle	No
Secondary	Number of follicles >10mm on day of human chorionic gonadotropin (hCG) administration;		1 cycle	No
Secondary	Number of days of stimulation;		1 cycle	No
Secondary	Estradiol level on the day of hCG administration;		1 cycle	No
Secondary	Clinical pregnancy rate per transfer: defined as the presence of an intrauterine sac on transvaginal ultrasound;		1 cycle	No
Secondary	Delivery rate per transfer;		1 cycle	No
Secondary	Safety (incidence of ovarian torsion, severe risk of ovarian hyperstimulation syndrome, enlarging hemorrhagic cysts, and serious adverse events)		1 cycle	No