InfertilityPhase 4NCT00225433
Luteal Phase FSH in the IVF Poor Responder
A Phase 4 study testing follitropin beta and ganirelix acetate in people with Infertility, run by University of Pennsylvania at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 20 to 42 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- follitropin beta and ganirelix acetate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to Jun 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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:
- <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
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- 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prior to any study-related procedure, not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania Reproductive Research Unit
Philadelphia, Pennsylvania, 19104
About this study
Official title: Luteal Phase Recombinant FSH vs. Follicular Phase Recombinant FSH for IVF Stimulation in the Poor Responder
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.
- Conditions
- Infertility
- Being tested
- follitropin beta, ganirelix acetate
- Keywords
- infertility, in vitro fertilization
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
follitropin betaDrug
Follitropin beta
ganirelix acetateDrug
Ganirelix acetate
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Follitropin beta Receives: Drug: follitropin beta |
| 2 | Active comparator | Ganirelix acetate Receives: Drug: ganirelix acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of oocytes retrieved for IVF
Measured: One cycle
Secondary outcomes (6)
Number of follicles >10mm on day of human chorionic gonadotropin (hCG) administration;
Measured: 1 cycle
Number of days of stimulation;
Measured: 1 cycle
Estradiol level on the day of hCG administration;
Measured: 1 cycle
Clinical pregnancy rate per transfer: defined as the presence of an intrauterine sac on transvaginal ultrasound;
Measured: 1 cycle
Delivery rate per transfer;
Measured: 1 cycle
Safety (incidence of ovarian torsion, severe risk of ovarian hyperstimulation syndrome, enlarging hemorrhagic cysts, and serious adverse events)
Measured: 1 cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2005 (estimated)
- Study startSep 2005
- Primary completionDec 2006
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kurt T Barnhart, MD, MSCE, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00225433
- Sponsor's protocol ID
- 803515
- Other IDs
- RRU013
- Status last verified
- Dec 2015
- First submitted
- 21 Sep 2005
- Last updated
- 3 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Luteal Phase Recombinant FSH vs. Follicular Phase Recombinant FSH for IVF Stimulation in the Poor Responder
- ClinicalTrials.gov ID
- NCT00225433
- Acronym / sponsor ID
- 803515
- Conditions
- Infertility
- Keywords
- infertility, in vitro fertilization
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Sep 2005
- Primary completion
- Dec 2006 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 23 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: follitropin betaFollitropin beta |
| 2 | Active comparator | Drug: ganirelix acetateGanirelix acetate |
Who may qualify
- Ages
- 20 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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:
- Aged 20-42 (inclusive) at the time of randomization
- Presence of both ovaries
- Normal pap smear within past three years
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| follitropin betaFollitropin beta | Drug | 1 |
| ganirelix acetateGanirelix acetate | Drug | 2 |
Primary outcome
Number of oocytes retrieved for IVF
Time frame: One cycle
6 secondary outcomes
Number of follicles >10mm on day of human chorionic gonadotropin (hCG) administration;
Time frame: 1 cycle
Number of days of stimulation;
Time frame: 1 cycle
Estradiol level on the day of hCG administration;
Time frame: 1 cycle
Clinical pregnancy rate per transfer: defined as the presence of an intrauterine sac on transvaginal ultrasound;
Time frame: 1 cycle
Delivery rate per transfer;
Time frame: 1 cycle
Safety (incidence of ovarian torsion, severe risk of ovarian hyperstimulation syndrome, enlarging hemorrhagic cysts, and serious adverse events)
Time frame: 1 cycle
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kurt T Barnhart, MD, MSCE principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing follitropin beta and ganirelix acetate in people with Infertility, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of oocytes retrieved for IVF (time frame: One cycle). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2015.