Polycystic Ovarian SyndromePhase 4NCT00805935
Menopur® Versus Follistim® in Polycystic Ovarian Syndrome (PCOS)
A Phase 4 study testing Menotropin, Progesterone vaginal insert and Follitropin beta in people with Polycystic Ovarian Syndrome and Infertility, run by Ferring Pharmaceuticals at 6 sites in United States.
Trial summary
This multicenter, randomized, open-label exploratory study will be performed in approximately 200 polycystic ovary syndrome (PCOS) but otherwise healthy females undergoing in vitro fertilization (IVF). Read more about this study
- Who is it for?
- Ages 18 to 42 years, women only
- Conditions the study is for
- Polycystic Ovarian Syndrome, Infertility
- What is being tested?
- Menotropin, Progesterone vaginal insert and Follitropin beta
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 6 sitesUnited States
- Study dates
- Jan 2009to Sep 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pre-menopausal females between the ages of 18 and 42 years
- Diagnosed with polycystic ovary syndrome (PCOS), using criteria adopted as the 2003 Rotterdam PCOS Consensus (2 out of 3, excluding other etiologies [congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome])
- Oligo- or anovulation
- Clinical and/or biochemical signs of hyperandrogenism
- Polycystic ovaries
- Body mass index (BMI) of 18-39
Show all 10Show fewer
- Early follicular phase (Day 3) follicle stimulating hormone (FSH) < 15 IU/L and estradiol (E2) within normal limits
- Documented history of infertility (e.g., unable to conceive for at least one year, or for 6 months for women > 38 years of age, or bilateral tubal occlusion or absence, or male factor but excluding severe male factor requiring invasive or surgical sperm retrieval. Donor sperm may be used.)
- Transvaginal ultrasound at screening consistent with findings adequate for assisted reproductive technology (ART) with respect to uterus and adnexa
- Signed informed consent
Who cannot join
- Gestational or surrogate carrier, donor oocyte
- Presence of any clinically relevant systemic disease (e.g., uncontrolled thyroid or adrenal dysfunction, an organic intracranial lesion such as a pituitary tumor, insulin-dependent diabetes mellitus, uterine cancer)
- Surgical or medical condition which, in the judgment of the Investigator or Sponsor, may interfere with absorption, distribution, metabolism, or excretion of the drugs to be used
- Two or more previous failed in vitro fertilization (IVF) cycles or in vitro fertilization (IVF)/assisted reproductive technology (ART) failure due to a poor response to gonadotropins, defined as development of 2 mature follicles
- History of recurrent pregnancy loss, defined as more than two clinical losses
- Presence of abnormal uterine bleeding of undetermined origin
Show all 11Show fewer
- Current or recent substance abuse, including alcohol or smoking > 10 cigarettes per day
- Refusal or inability to comply with the requirements of the Protocol for any reason, including scheduled clinic visits and laboratory tests
- Participation in any experimental drug study within 30 days prior to Screening
- Severe male factor requiring invasive or surgical sperm retrieval (e.g., microsurgical epididymal sperm aspiration [MESA], testicular sperm extraction [TESE])
- Prior hypersensitivity to any of the protocol drugs
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Center for Assisted Reproduction
Bedford, Texas, 76022
Fertility Center of Illinois
Chicago, Illinois, 60610
Women's Medical Research Group LLC, Florida
Clearwater, Florida, 33759
Conceptions Reproductive Associates of Colorado
Littleton, Colorado, 80129
Weill Cornell Medical College
New York, New York, 10021
Women & Infants' Hospital of RI
Providence, Rhode Island, 02905
About this study
Official title: A Multi-Center, Randomized, Open-Label Evaluation of MENOPUR® Versus FOLLISTIM® in Polycystic Ovarian Syndrome (PCOS) Patients
This multicenter, randomized, open-label exploratory study will be performed in approximately 200 polycystic ovary syndrome (PCOS) but otherwise healthy females undergoing in vitro fertilization (IVF). Each study center will follow its standard practice for in vitro fertilization (IVF) within the study parameters as noted in this protocol. The study centers will use marketed products purchased from Schraft's Pharmacy for all phases of the study (down-regulation, stimulation, ovulation induction, and luteal support). Subjects will be randomly assigned to highly purified menotropin (Menopur®) or follitropin beta (Follistim Pen®) for stimulation and progesterone vaginal insert (Endometrin®) or progesterone in oil for luteal support. Subjects will return to the study center for regular scheduled clinic visits as required per in vitro fertilization (IVF) protocol at the site and at specified times during the cycle (Stimulation Day 6, Day of human chorionic gonadotropin (hCG), and first serum pregnancy test) for estradiol (E2), progesterone (P4) and human chorionic gonadotropin (hCG) labs. All subjects will be required to complete a final study visit at completion of luteal support or negative serum pregnancy test following embryo transfer.
- Conditions
- Polycystic Ovarian Syndrome, Infertility
- Being tested
- Menotropin, Progesterone vaginal insert, Follitropin beta, Progesterone in oil, leuprolide acetate
- Keywords
- pre-menopausal women, PCOS, polycystic ovarian syndrome, infertility, IVF, in vitro fertilization
- Medical subject headings
- Polycystic Ovary Syndrome, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MenotropinDrug
Also called Menopur®
225 IU (up to 450 IU) by subcutaneous injection once per day for up to about 15 days.
Progesterone vaginal insertDrug
Also called Endometrin®
100 mg inserted vaginally 2 or 3 times daily (BID or TID) (start on the day after oocyte retrieval) until 10 weeks gestation or confirmation of negative pregnancy test.
Follitropin betaDrug
Also called Follistim Pen®
225 IU (up to 450 IU) by subcutaneous injection once per day for up to about 15 days.
Progesterone in oilDrug
50 mg by intramuscular injection once per day, starting on the day after oocyte retrieval until 10 weeks gestation or confirmation of negative pregnancy test.
leuprolide acetateDrug
Also called Lupron
Daily administration of 0.5mg of leuprolide acetate (depot formulations were not permitted) began on Day 21 following onset of menses, and then decreased to 0.25 mg when gonadotropin therapy was initiated.
| Study group | Role | What they receive |
|---|---|---|
| Menotropin/Progesterone vaginal insert | Experimental | Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone vaginal insert (Endometrin®) 100 mg starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained. Receives: Drug: Menotropin; Drug: Progesterone vaginal insert; Drug: leuprolide acetate |
| Menotropin/Progesterone in oil | Experimental | Menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained. Receives: Drug: Menotropin; Drug: Progesterone in oil; Drug: leuprolide acetate |
| Follitropin beta/Progesterone vaginal insert | Active comparator | Follitropin beta (Follistim Pen®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone vaginal insert (Endometrin®) 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained. Receives: Drug: Progesterone vaginal insert; Drug: Follitropin beta; Drug: leuprolide acetate |
| Follitropin beta/Progesterone in oil | Active comparator | Follitropin beta (Follistim Pen®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained. Receives: Drug: Follitropin beta; Drug: Progesterone in oil; Drug: leuprolide acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants With Cycle Cancellation Due to Risk of Ovarian Hyperstimulation Syndrome (OHSS) Between Weeks 1 - 3
A count of participants whose discontinuation was clearly documented on the study completion/termination form as cycle cancellation for risk of ovarian hyperstimulation syndrome (OHSS).
Measured: weeks 1-3
Secondary outcomes (13)
Number of Follicles Observed at Day 15
The mean number of follicles observed in both ovaries at the last transvaginal ultrasound in the stimulation phase.
Measured: approximately day 15
Number of Oocytes Retrieved at Day 18
The mean number of oocytes retrieved approximately 36 hours after hCG (Novarel®) administration and fertilized (by insemination or intra cytoplasmic sperm injection (ICSI)) according to site-specific procedures.
Measured: approximately day 18
Percentage of Oocytes Fertilized of the Total Number of Oocytes Retrieved
The fertilization rate for each participant was the percentage of the number of oocytes inseminated of the total number of oocytes retrieved.
Measured: approximately day 19
Number of Embryos Transferred at Three Stages of Development Before Implantation
The number of embryos, morulas and blastocysts transferred to the study participant on either day 3 or day 5 following fertilization. Embryos represent the earliest development stage and contain 2-8 cells.
Morulas, the next stage, continued cellular cleavage results in a 16-30 cell solid sphere. Morula further develop into blastocyst, which contains 70-100 cells in a hollow spherical shape.
Measured: approximately day 24
Number of Embryos Frozen
The number of embryos that were not transferred but instead were frozen for future use.
Measured: approximately day 24
Percentage of Participants With Biochemical Pregnancy at Approximately Day 38
Biochemical pregnancy is a positive β-hCG pregnancy test 12-14 days post embryo transfer.
Measured: approximately day 38 (Day 14 post embryo transfer)
Percentage of Participants With Clinical Pregnancy at Week 7
Clinical pregnancy is the confirmation of the presence of intrauterine gestational sacs on pregnancy ultrasound examination.
Measured: approximately Day 52
Percentage of Participants With Ongoing Pregnancy at Week 9
Clinical pregnancy is the confirmation of the presence of intrauterine gestational sacs on pregnancy ultrasound examination.
Measured: approximately Day 65
Estradiol Levels at Day 6
Estradiol monitoring during fertility therapy assesses follicular growth and is useful in monitoring the treatment. Blood tests sent to a central laboratory to obtain estradiol levels.
Measured: Day 6
Human Chorionic Gonadotropin (hCG) Levels at Day 6
Blood tests were sent to a central laboratory to obtain hCG levels.
Measured: Day 6
Progesterone Levels at Human Chorionic Gonadotropin (hCG) Administration
Blood tests were sent to a central laboratory to obtain progesterone levels.
Measured: approximately day 16
Number of Live Births Resulting From the In Vitro Fertilization Process
Number of live births resulting from the IVF process
Measured: Approximately 10 months
Participants With Treatment Emergent Adverse Events
Number of participants with adverse events (AEs) that started after first treatment. Severity used a three point scale:
mild=awareness of signs/symptoms, but no disruption of usual activity moderate=event sufficient to affect usual activity (disturbing) severe=event causes inability to work or perform usual activities (unacceptable) Relatedness to study treatment used a four point scale: unrelated, unlikely, possible, probable.
Seriousness refers to death, hospitalization, a life-threatening experience, persistent or significant disability/incapacity, or congenital anomaly.
Measured: Week 1 to week12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2008 (estimated)
- Study startJan 2009
- Primary completionJul 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Polycystic Ovarian SyndromeStudies of the same condition, open and under way.
- 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
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferring Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Development Support, Study director, Ferring Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00805935
- Sponsor's protocol ID
- 2008-05
- Status last verified
- Jan 2012
- First submitted
- 9 Dec 2008
- Last updated
- 27 Jan 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Beltsos AN, Sanchez MD, Doody KJ, Bush MR, Domar AD, Collins MG. Patients' administration preferences: progesterone vaginal insert (Endometrin(R)) compared to intramuscular progesterone for Luteal phase support. Reprod Health. 2014 Nov 11;11:78. doi: 10.1186/1742-4755-11-78.
PubMed 25385669
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Randomized, Open-Label Evaluation of MENOPUR® Versus FOLLISTIM® in Polycystic Ovarian Syndrome (PCOS) Patients
- ClinicalTrials.gov ID
- NCT00805935
- Acronym / sponsor ID
- 2008-05
- Conditions
- Polycystic Ovarian Syndrome, Infertility
- Keywords
- pre-menopausal women, PCOS, polycystic ovarian syndrome, infertility, IVF, in vitro fertilization
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 10 Dec 2008 (estimated)
- Results
- Posted 25 Jan 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This multicenter, randomized, open-label exploratory study will be performed in approximately 200 polycystic ovary syndrome (PCOS) but otherwise healthy females undergoing in vitro fertilization (IVF). Each study center will follow its standard practice for in vitro fertilization (IVF) within the study parameters as noted in this protocol. The study centers will use marketed products purchased from Schraft's Pharmacy for all phases of the study (down-regulation, stimulation, ovulation induction, and luteal support). Subjects will be randomly assigned to highly purified menotropin (Menopur®) or follitropin beta (Follistim Pen®) for stimulation and progesterone vaginal insert (Endometrin®) or progesterone in oil for luteal support. Subjects will return to the study center for regular scheduled clinic visits as required per in vitro fertilization (IVF) protocol at the site and at specified times during the cycle (Stimulation Day 6, Day of human chorionic gonadotropin (hCG), and first serum pregnancy test) for estradiol (E2), progesterone (P4) and human chorionic gonadotropin (hCG) labs. All subjects will be required to complete a final study visit at completion of luteal support or negative serum pregnancy test following embryo transfer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Menotropin/Progesterone vaginal insert | Experimental | Drug: Menotropin, Drug: Progesterone vaginal insert, Drug: leuprolide acetateHighly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met. Progesterone vaginal insert (Endometrin®) 100 mg starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained. |
| Menotropin/Progesterone in oil | Experimental | Drug: Menotropin, Drug: Progesterone in oil, Drug: leuprolide acetateMenotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met. Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained. |
| Follitropin beta/Progesterone vaginal insert | Active comparator | Drug: Progesterone vaginal insert, Drug: Follitropin beta, Drug: leuprolide acetateFollitropin beta (Follistim Pen®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met. Progesterone vaginal insert (Endometrin®) 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained. |
| Follitropin beta/Progesterone in oil | Active comparator | Drug: Follitropin beta, Drug: Progesterone in oil, Drug: leuprolide acetateFollitropin beta (Follistim Pen®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met. Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained. |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Pre-menopausal females between the ages of 18 and 42 years
- Diagnosed with polycystic ovary syndrome (PCOS), using criteria adopted as the 2003 Rotterdam PCOS Consensus (2 out of 3, excluding other etiologies [congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome])
- Body mass index (BMI) of 18-39
- Early follicular phase (Day 3) follicle stimulating hormone (FSH) < 15 IU/L and estradiol (E2) within normal limits
- Documented history of infertility (e.g., unable to conceive for at least one year, or for 6 months for women > 38 years of age, or bilateral tubal occlusion or absence, or male factor but excluding severe male factor requiring invasive or surgical sperm retrieval. Donor sperm may be used.)
Key exclusion criteria (11 listed)
- Gestational or surrogate carrier, donor oocyte
- Presence of any clinically relevant systemic disease (e.g., uncontrolled thyroid or adrenal dysfunction, an organic intracranial lesion such as a pituitary tumor, insulin-dependent diabetes mellitus, uterine cancer)
- Surgical or medical condition which, in the judgment of the Investigator or Sponsor, may interfere with absorption, distribution, metabolism, or excretion of the drugs to be used
- Two or more previous failed in vitro fertilization (IVF) cycles or in vitro fertilization (IVF)/assisted reproductive technology (ART) failure due to a poor response to gonadotropins, defined as development of 2 mature follicles
- History of recurrent pregnancy loss, defined as more than two clinical losses
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 |
|---|---|---|
| MenotropinAlso: Menopur®225 IU (up to 450 IU) by subcutaneous injection once per day for up to about 15 days. | Drug | Menotropin/Progesterone in oil, Menotropin/Progesterone vaginal insert |
| Progesterone vaginal insertAlso: Endometrin®100 mg inserted vaginally 2 or 3 times daily (BID or TID) (start on the day after oocyte retrieval) until 10 weeks gestation or confirmation of negative pregnancy test. | Drug | Follitropin beta/Progesterone vaginal insert, Menotropin/Progesterone vaginal insert |
| Follitropin betaAlso: Follistim Pen®225 IU (up to 450 IU) by subcutaneous injection once per day for up to about 15 days. | Drug | Follitropin beta/Progesterone in oil, Follitropin beta/Progesterone vaginal insert |
| Progesterone in oil50 mg by intramuscular injection once per day, starting on the day after oocyte retrieval until 10 weeks gestation or confirmation of negative pregnancy test. | Drug | Follitropin beta/Progesterone in oil, Menotropin/Progesterone in oil |
| leuprolide acetateAlso: LupronDaily administration of 0.5mg of leuprolide acetate (depot formulations were not permitted) began on Day 21 following onset of menses, and then decreased to 0.25 mg when gonadotropin therapy was initiated. | Drug | Follitropin beta/Progesterone in oil, Follitropin beta/Progesterone vaginal insert, Menotropin/Progesterone in oil, Menotropin/Progesterone vaginal insert |
Primary outcome
Participants With Cycle Cancellation Due to Risk of Ovarian Hyperstimulation Syndrome (OHSS) Between Weeks 1 - 3
Time frame: weeks 1-3
A count of participants whose discontinuation was clearly documented on the study completion/termination form as cycle cancellation for risk of ovarian hyperstimulation syndrome (OHSS).
13 secondary outcomes
Number of Follicles Observed at Day 15
Time frame: approximately day 15
Number of Oocytes Retrieved at Day 18
Time frame: approximately day 18
Percentage of Oocytes Fertilized of the Total Number of Oocytes Retrieved
Time frame: approximately day 19
Number of Embryos Transferred at Three Stages of Development Before Implantation
Time frame: approximately day 24
Number of Embryos Frozen
Time frame: approximately day 24
Percentage of Participants With Biochemical Pregnancy at Approximately Day 38
Time frame: approximately day 38 (Day 14 post embryo transfer)
Percentage of Participants With Clinical Pregnancy at Week 7
Time frame: approximately Day 52
Percentage of Participants With Ongoing Pregnancy at Week 9
Time frame: approximately Day 65
Estradiol Levels at Day 6
Time frame: Day 6
Human Chorionic Gonadotropin (hCG) Levels at Day 6
Time frame: Day 6
Progesterone Levels at Human Chorionic Gonadotropin (hCG) Administration
Time frame: approximately day 16
Number of Live Births Resulting From the In Vitro Fertilization Process
Time frame: Approximately 10 months
Participants With Treatment Emergent Adverse Events
Time frame: Week 1 to week12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25385669Beltsos AN, Sanchez MD, Doody KJ, Bush MR, Domar AD, Collins MG. Patients' administration preferences: progesterone vaginal insert (Endometrin(R)) compared to intramuscular progesterone for Luteal phase support. Reprod Health. 2014 Nov 11;11:78. doi: 10.1186/1742-4755-11-78.
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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.
Clinical Development Support study director
Ferring Pharmaceuticals
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Menotropin, Progesterone vaginal insert and Follitropin beta in people with Polycystic Ovarian Syndrome and Infertility, run by Ferring Pharmaceuticals at 6 sites 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 10 inclusion and 11 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 27 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
Yes. Results are posted in the registry (first posted 25 Jan 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Participants With Cycle Cancellation Due to Risk of Ovarian Hyperstimulation Syndrome (OHSS) Between Weeks 1 - 3 (time frame: weeks 1-3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00805935, which also lists 1 linked publication.
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 27 Jan 2012.