InfertilityPhase 3NCT01497197
A Trial to Compare the Efficacy and Safety of Ovarian Stimulation With GONAL-f® and Luveris® Starting on Day 1 Versus Day 6 in Women Undergoing Assisted Reproductive Technique
A Phase 3 study testing GONAL-f®, Luveris® and Recombinant human chorionic gonadotropin (r-hCG) in people with Infertility and Fertility, run by Merck KGaA, Darmstadt, Germany at 1 site in United Arab Emirates.
Trial summary
This is a phase IIIb, interventional, multicenter, multinational, randomised, open-label, comparative trial which primary objective is to generate data on the ovarian stimulation profile obtained when Luveris® is started either on Day 1 or Day 6 in women in advanced reproductive age (36-42) undergoing Assisted… Read more about this study
- Who is it for?
- Ages 36 to 42 years, women only
- Conditions the study is for
- Infertility, Fertility, Follicle Stimulating Hormone Deficiency
- What is being tested?
- GONAL-f®, Luveris® and Recombinant human chorionic gonadotropin (r-hCG)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- May 2012to Jan 2014
- Phase
- Phase 3
- 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 36 to 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Should be a female subject justifying an In Vitro Fertilization/Embryo transfer (IVF)/ET treatment
- Should be between 36th and 42nd birthday (both included) at the time of the randomization visit
- Have early follicular phase (day 2-4) serum level of basal FSH <= 12 IU/L measured in the center's local laboratory during the screening period (i.e. within 2 months prior to down regulation start)
- Have a regular spontaneous ovulatory menstrual cycle between 21 and 35 days in length
- Presence of both ovaries
- Normal uterine cavity, which in the investigator's opinion is compatible with Pregnancy
Show all 11Show fewer
- Have a negative cervical Papanicolaou (PAP or smear) test within the last 6 months prior to randomization
- Have at least one wash-out cycle (defined as >=30 days since the last dose of clomiphene citrate or gonadotrophin treatment) since the last ART cycle and/or clomiphene citrate or gonadotrophin treatment prior to starting GnRH agonist therapy
- Be willing and able to comply with the protocol for the duration of the trial
- Have given written informed consent, prior to any trial-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to her future medical care
- Have a male partner with semen analysis within the past 6 months prior to randomization considered adequate to proceed with regular insemination or intra-cytoplasmic sperm injection (ICSI) according to the center's standard practice
Who cannot join
- Had 2 (or more) previous ART cycles with a poor response to gonadotrophin stimulation defined as 6 (or less) mature follicles and/or 4 (or less) oocytes collected in any previous IVF cycle or previous cycles with a hyper response defined as 25 (or more) oocytes retrieved
- Any medical condition, which in the judgment of the investigator may interfere with the absorption, distribution, metabolism or excretion of the drug. In case of doubt, the subject in question should be discussed with Merck Serono's Medical responsible
- Had previous severe ovarian hyperstimulation syndrome (OHSS)
- Polycystic ovary syndrome (PCOS; Rotterdam criteria) to reduce the risk of the occurrence of OHSS
- Presence of endometriosis requiring treatment
- Uterine myoma requiring treatment
Show all 20Show fewer
- Any contraindication to being pregnant and/or carrying a pregnancy to term
- Extra-uterine pregnancy within the last 3 months prior to screening
- History of 3 or more miscarriages (early or late miscarriages) due to any cause
- Tumours of the hypothalamus and pituitary gland
- Ovarian enlargement or cyst of unknown etiology
- Ovarian, uterine or mammary cancer
- A clinically significant systemic disease
- Known infection with Human Immunodeficiency Virus (HIV), Hepatitis B or C virus in the trial subject or her male partner
- Abnormal gynecological bleeding of undetermined origin
- Known allergy or hypersensitivity to human gonadotrophin preparations
- Any active substance abuse or history of drug, medication or alcohol abuse in the past 5 years prior to the screening visit
- Entered previously into this trial or simultaneous participation in another clinical trial
- Pregnancy and lactation period
- Participation in another clinical trial within the past 30 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase IIIb, Interventional, Multicentre, Multinational, Randomised, Open-label Trial to Compare the Efficacy and Safety of Ovarian Stimulation With GONAL-f® and Luveris® Starting on Day 1 vs. Day 6 in Women Between 36 and 42 Years of Age Undergoing Assisted Reproductive Technique (ART)
This is a phase IIIb, interventional, multicenter, multinational, randomised, open-label, comparative trial which primary objective is to generate data on the ovarian stimulation profile obtained when Luveris® is started either on Day 1 or Day 6 in women in advanced reproductive age (36-42) undergoing Assisted Reproductive Technique (ART).
Read the detailed description
The subjects who complete the screening assessments and fulfil all the eligibility criteria will start down-regulation treatment on day 21-22 of the cycle.
Down-regulation treatment must start within 2 months following the screening visit. The routine long luteal phase protocol for Gonadotrophin-releasing hormone (GnRH) agonist treatment will be followed.
Once down-regulation has been confirmed, a pregnancy test will be performed within 1 week prior to start of Recombinant human follicle stimulating hormone (r-hFSH) treatment to rule out any pre-existing pregnancy. If the result is negative, the subject will be randomly assigned to one of the two treatment arms of the trial:
- GONAL-f® (Liquid Pen; 300 IU of per day) stimulation day 1-5 then followed by Luveris® (vial/powder, 150 IU per day) from stimulation Day 1 and until required r-hCG level is met. The dose can be adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
- GONAL-f® (Liquid Pen; 300 IU per day) stimulation Day 1-5 then add Luveris® (vial/powder, 150 IU per day) from stimulation Day 6 and until required recombinant Human chorionic gonadotrophin (r-hCG) level is met. The dose can be adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
Randomization across the two treatment arms will be kept balanced in a 1:1 ratio. Subjects will be provided with a subject diary (including r-hCG and Crinone® administration and safety information) to record daily dosing information for GONAL-f® and Luveris®.
Follicular development will be monitored according to the center's standard practice by US and/or Oestradiol (E2) levels, until the protocol r-hCG requirement is met (i.e., at least 1 follicle greater or equal to 18 mm and 2 follicles greater or equal to 16 millimeter [mm]). After this, a single injection of 250 microgram (mcg) of r-hCG (Ovidrel®/Ovitrelle®), will be administered in order to induce final oocyte maturation.
At a time of 34-38 hours after r-hCG administration, oocytes will be recovered vaginally under US monitoring. Oocytes will then be fertilized in vitro and embryos replaced 2-3 days after oocyte recovery. Ovum pick up (OPU), in vitro fertilization (IVF), Embryo Transfer (ET) and luteal support will be performed as per center's standard practice. In addition, Crinone® 8% (progesterone gel) will be administered once daily.
A post-treatment safety visit will be performed for all subjects who received r-hCG (pregnant and non-pregnant) on post r-hCG Day 15-20. For subjects who have withdrawn from treatment (i.e. after starting Luveris® or GONAL f® but before r-hCG is given) this visit will take place 20-30 days after their first Luveris® or GONAL-f® treatment injection (excluding pregnancy testing).
- Being tested
- GONAL-f®, Luveris®, Recombinant human chorionic gonadotropin (r-hCG)
- Keywords
- Reproduction Techniques, Reproductive Medicine, Assisted Reproductive Technics, Pregnancy Rate, Ovulation Induction, Ovarian Stimulation, Oocytes, Implantation
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GONAL-f®Drug
GONAL f® 300 international units [IU] per day as subcutaneous injection using liquid pen.
Luveris®Drug
Luveris® 150 IU per day lyophilized powder for subcutaneous injection.
Recombinant human chorionic gonadotropin (r-hCG)Biological
A single injection of r-hCG (Ovidrel®/Ovitrelle®) 250 mcg to induce final oocyte maturation.
| Study group | Role | What they receive |
|---|---|---|
| Gonal-f®+Luveris® | Experimental | GONAL f® 300 international units [IU] per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 1 until required recombinant human chorionic gonadotropin (r-hCG) level is met. The dose will be adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice. Receives: Drug: GONAL-f®; Drug: Luveris®; Biological: Recombinant human chorionic gonadotropin (r-hCG) |
| Gonal-f® Followed by Luveris® | Experimental | GONAL-f® 300 IU per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 6 until required r-hCG level is met. The dose will be adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice. Receives: Drug: GONAL-f®; Drug: Luveris®; Biological: Recombinant human chorionic gonadotropin (r-hCG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Number of Oocytes Retrieved Per Subject Following Ovarian Stimulation
Ovarian stimulation was performed using in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI). The total number of oocytes collected per subject following stimulation was reported.
Measured: 34-38 hours post r-hCG administration
Secondary outcomes (10)
Total Dose and Mean Daily Dose of Follicle Stimulating Hormone (FSH)
Mean daily dose of FSH was to be determined by dividing the total daily dose by the number of stimulation days.
Measured: Screening
Total Number of Stimulation Treatment Days
The total number of stimulation treatment days for each subject was determined based on the treatment administration information collected in the case report form.
Measured: 6 days post stimulation (Number of stimulation days+6 days)
Implantation Rate
The implantation rate was determined as number of fetal sacs divided by the number of embryos transferred post r-hCG administration.
Measured: 35-42 days post r-hCG administration
Number of Fetal Sacs With Activity
Number of fetal sacs with activity was evaluated by ultrasound scan (US) on Days 35-42 post r-hCG to confirm clinical pregnancy.
Measured: 35-42 days post r-hCG administration
Number of Fetal Sacs With Detectable Heart Beats
Number of fetal sacs with detectable heart beats was evaluated by US on Days 35-42 post r-hCG to confirm clinical pregnancy
Measured: 35-42 days post r-hCG administration
Total Pregnancy Rate and Clinical Pregnancy Rate
The subject was considered to have a positive pregnancy result if beta-hCG >10 international units per liter (IU/L) and the subject had not menstruated between post-r-hCG Days 15-20. Clinical pregnancy was defined as the existence of at least an US confirmed gestational sac in the uterus with fetal heart activity post-r-hCG Days 35-42.
Measured: 35-42 days post r-hCG administration
Cycle Cancellation Rate Prior to r-hCG
If the subject was not administered with r-hCG and withdrew prematurely from the trial, it was considered as cycle cancellation.
Measured: Up to 85 days
Number of Subjects With Biochemical Pregnancies
Biochemical pregnancy was defined as the pregnancy diagnosed only by the detection of hCG in serum or urine and that does not develop into a clinical pregnancy. Subjects with beta-hCG concentration greater than 10 IU/L were considered as biochemical pregnant.
Measured: 35 to 42 days post r-hCG administration
Number of Subjects With Multiple Pregnancies
Multiple pregnancy was defined as the existence of more than one ultrasound confirmed gestational sac in the uterus with fetal heart activity at post-r-hCG Days 35-42.
Measured: 35 to 42 days post r-hCG administration
Number of Subjects With Any Adverse Events (AEs), Serious AEs, AEs Leading to Death, and AEs Leading to Discontinuation
An AE was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A serious AE is an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
Measured: Baseline up to 15-20 days post r-hCG administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2011 (estimated)
- Study startMay 2012
- Primary completionJan 2014
- Study completionJan 2014
Why it stopped: Study was terminated as per sponsor's decision
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.
- Other trials for InfertilityStudies 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Serono Middle East FZ LLC
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Serono Middle East FZ LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01497197
- Sponsor's protocol ID
- EMR200061-506
- Status last verified
- Oct 2015
- First submitted
- 20 Dec 2011
- Last updated
- 9 Nov 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIIb, Interventional, Multicentre, Multinational, Randomised, Open-label Trial to Compare the Efficacy and Safety of Ovarian Stimulation With GONAL-f® and Luveris® Starting on Day 1 vs. Day 6 in Women Between 36 and 42 Years of Age Undergoing Assisted Reproductive Technique (ART)
- ClinicalTrials.gov ID
- NCT01497197
- Acronym / sponsor ID
- EMR200061-506
- Keywords
- Reproduction Techniques, Reproductive Medicine, Assisted Reproductive Technics, Pregnancy Rate, Ovulation Induction, Ovarian Stimulation, Oocytes, Implantation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was terminated as per sponsor's decision
- Enrolment
- 174 participants (actual)
- Lead sponsor
- Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
- Collaborators
- Merck Serono Middle East FZ LLC
- Study start
- May 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 22 Dec 2011 (estimated)
- Results
- Posted 9 Nov 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase IIIb, interventional, multicenter, multinational, randomised, open-label, comparative trial which primary objective is to generate data on the ovarian stimulation profile obtained when Luveris® is started either on Day 1 or Day 6 in women in advanced reproductive age (36-42) undergoing Assisted Reproductive Technique (ART).
Detailed description
The subjects who complete the screening assessments and fulfil all the eligibility criteria will start down-regulation treatment on day 21-22 of the cycle.
Down-regulation treatment must start within 2 months following the screening visit. The routine long luteal phase protocol for Gonadotrophin-releasing hormone (GnRH) agonist treatment will be followed.
Once down-regulation has been confirmed, a pregnancy test will be performed within 1 week prior to start of Recombinant human follicle stimulating hormone (r-hFSH) treatment to rule out any pre-existing pregnancy. If the result is negative, the subject will be randomly assigned to one of the two treatment arms of the trial:
- GONAL-f® (Liquid Pen; 300 IU of per day) stimulation day 1-5 then followed by Luveris® (vial/powder, 150 IU per day) from stimulation Day 1 and until required r-hCG level is met. The dose can be adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
- GONAL-f® (Liquid Pen; 300 IU per day) stimulation Day 1-5 then add Luveris® (vial/powder, 150 IU per day) from stimulation Day 6 and until required recombinant Human chorionic gonadotrophin (r-hCG) level is met. The dose can be adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
Randomization across the two treatment arms will be kept balanced in a 1:1 ratio. Subjects will be provided with a subject diary (including r-hCG and Crinone® administration and safety information) to record daily dosing information for GONAL-f® and Luveris®.
Follicular development will be monitored according to the center's standard practice by US and/or Oestradiol (E2) levels, until the protocol r-hCG requirement is met (i.e., at least 1 follicle greater or equal to 18 mm and 2 follicles greater or equal to 16 millimeter [mm]). After this, a single injection of 250 microgram (mcg) of r-hCG (Ovidrel®/Ovitrelle®), will be administered in order to induce final oocyte maturation.
At a time of 34-38 hours after r-hCG administration, oocytes will be recovered vaginally under US monitoring. Oocytes will then be fertilized in vitro and embryos replaced 2-3 days after oocyte recovery. Ovum pick up (OPU), in vitro fertilization (IVF), Embryo Transfer (ET) and luteal support will be performed as per center's standard practice. In addition, Crinone® 8% (progesterone gel) will be administered once daily.
A post-treatment safety visit will be performed for all subjects who received r-hCG (pregnant and non-pregnant) on post r-hCG Day 15-20. For subjects who have withdrawn from treatment (i.e. after starting Luveris® or GONAL f® but before r-hCG is given) this visit will take place 20-30 days after their first Luveris® or GONAL-f® treatment injection (excluding pregnancy testing).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gonal-f®+Luveris® | Experimental | Drug: GONAL-f®, Drug: Luveris®, Biological: Recombinant human chorionic gonadotropin (r-hCG)GONAL f® 300 international units [IU] per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 1 until required recombinant human chorionic gonadotropin (r-hCG) level is met. The dose will be adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice. |
| Gonal-f® Followed by Luveris® | Experimental | Drug: GONAL-f®, Drug: Luveris®, Biological: Recombinant human chorionic gonadotropin (r-hCG)GONAL-f® 300 IU per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 6 until required r-hCG level is met. The dose will be adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice. |
Who may qualify
- Ages
- 36 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Should be a female subject justifying an In Vitro Fertilization/Embryo transfer (IVF)/ET treatment
- Should be between 36th and 42nd birthday (both included) at the time of the randomization visit
- Have early follicular phase (day 2-4) serum level of basal FSH <= 12 IU/L measured in the center's local laboratory during the screening period (i.e. within 2 months prior to down regulation start)
- Have a regular spontaneous ovulatory menstrual cycle between 21 and 35 days in length
- Presence of both ovaries
Key exclusion criteria (20 listed)
- Had 2 (or more) previous ART cycles with a poor response to gonadotrophin stimulation defined as 6 (or less) mature follicles and/or 4 (or less) oocytes collected in any previous IVF cycle or previous cycles with a hyper response defined as 25 (or more) oocytes retrieved
- Any medical condition, which in the judgment of the investigator may interfere with the absorption, distribution, metabolism or excretion of the drug. In case of doubt, the subject in question should be discussed with Merck Serono's Medical responsible
- Had previous severe ovarian hyperstimulation syndrome (OHSS)
- Polycystic ovary syndrome (PCOS; Rotterdam criteria) to reduce the risk of the occurrence of OHSS
- Presence of endometriosis requiring treatment
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 |
|---|---|---|
| GONAL-f®GONAL f® 300 international units [IU] per day as subcutaneous injection using liquid pen. | Drug | Gonal-f® Followed by Luveris®, Gonal-f®+Luveris® |
| Luveris®Luveris® 150 IU per day lyophilized powder for subcutaneous injection. | Drug | Gonal-f® Followed by Luveris®, Gonal-f®+Luveris® |
| Recombinant human chorionic gonadotropin (r-hCG)A single injection of r-hCG (Ovidrel®/Ovitrelle®) 250 mcg to induce final oocyte maturation. | Biological | Gonal-f® Followed by Luveris®, Gonal-f®+Luveris® |
Primary outcome
Total Number of Oocytes Retrieved Per Subject Following Ovarian Stimulation
Time frame: 34-38 hours post r-hCG administration
Ovarian stimulation was performed using in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI). The total number of oocytes collected per subject following stimulation was reported.
10 secondary outcomes
Total Dose and Mean Daily Dose of Follicle Stimulating Hormone (FSH)
Time frame: Screening
Total Number of Stimulation Treatment Days
Time frame: 6 days post stimulation (Number of stimulation days+6 days)
Implantation Rate
Time frame: 35-42 days post r-hCG administration
Number of Fetal Sacs With Activity
Time frame: 35-42 days post r-hCG administration
Number of Fetal Sacs With Detectable Heart Beats
Time frame: 35-42 days post r-hCG administration
Total Pregnancy Rate and Clinical Pregnancy Rate
Time frame: 35-42 days post r-hCG administration
Cycle Cancellation Rate Prior to r-hCG
Time frame: Up to 85 days
Number of Subjects With Biochemical Pregnancies
Time frame: 35 to 42 days post r-hCG administration
Number of Subjects With Multiple Pregnancies
Time frame: 35 to 42 days post r-hCG administration
Number of Subjects With Any Adverse Events (AEs), Serious AEs, AEs Leading to Death, and AEs Leading to Discontinuation
Time frame: Baseline up to 15-20 days post r-hCG administration
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Medical Director study director
Merck Serono Middle East FZ LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing GONAL-f®, Luveris® and Recombinant human chorionic gonadotropin (r-hCG) in people with Infertility and Fertility, run by Merck KGaA, Darmstadt, Germany at 1 site in United Arab Emirates.
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 11 inclusion and 20 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: stopped early, as of the sponsor's last update on 9 Nov 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 Arab Emirates. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 9 Nov 2015). 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?
Total Number of Oocytes Retrieved Per Subject Following Ovarian Stimulation (time frame: 34-38 hours post r-hCG administration). 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 9 Nov 2015.