InfertilityPhase 3NCT01687712
Phase III Study Comparing Efficacy and Safety of AFOLIA vs Gonal-f® RFF in Women (35 to 42) Undergoing IVF
A Phase 3 study testing AFOLIA and Gonal-f® RFF in people with Infertility, run by Fertility Biotech AG at 22 sites in United States.
Trial summary
The purpose of this study is to show that AFOLIA, a recombinant manufactured human follicle stimulating hormone (r-hFSH) has a similar efficacy and safety profile compared to Gonal-f® RFF. Read more about this study
- Who is it for?
- Ages 35 to 42 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- AFOLIA and Gonal-f® RFF
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,100 participants
- Where
- 22 sitesUnited States
- Study dates
- 25 Nov 2013to 14 Nov 2016
- 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 35 to 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 35 to 42 years of age
- Indication for controlled ovarian stimulation and IVF or intracytoplasmic sperm injection (ICSI)
- Regular menstrual cycles (25-35 days)
- History of a maximum of two fresh cycle treatments in the present series of assisted reproductive technologies (ART) at the day of first screening (thawed cycles are not subject to that criteria)
- Body mass index (BMI) ≥18 and ≤38 kg/m2
- Basal FSH <12 IU/L (cycle day 2-5)
Show all 12Show fewer
- Antral follicle count (AFC) ≥ 10 to ≤20 follicles with a diameter of <11mm (sum of both ovaries) as measured on ultrasound (US) in the early follicular phase (menstrual cycle day 2-5)
- Documented history of infertility due to any of the following factors: tubal factor, mild endometriosis (American Society for Reproductive Medicine [ASRM] stage 1-2), male factor, unexplained infertility
- Presence of both ovaries by ultrasonography and normal uterine cavity (confirmed by hysterosalpingography, saline infusion sonography or hysteroscopy within 6 months before randomization)
- Male partner with semen analysis that is at least adequate for ICSI within 6 months prior to patient beginning down-regulation (invasive or surgical sperm retrieval, donor and/or cryopreserved sperm may be used)
- Willingness to participate in the study and to comply with the study protocol
- Signed informed consent prior to screening
Who cannot join
- Presence of pregnancy
- History of or active polycystic ovary syndrome (PCOS)
- AFC >20 follicles with a diameter of <11 mm (both ovaries combined) as measured on US in the early follicular phase (menstrual cycle day 2-5)
- History of >2 unsuccessful fresh ART retrieval cycles
- Presence of uncontrolled endocrine disorder
- Previous history or presence of severe OHSS
Show all 19Show fewer
- Intrauterine fibroids ≥5 cm or otherwise clinically relevant pathology that could impair embryo implantation or pregnancy continuation
- History of recurrent spontaneous abortion (3 or more, even when unexplained)
- Presence of severe endometriosis (ASRM stage 3 or stage 4) or hydrosalpinx
- Neoplasia, including tumors of the hypothalamus and pituitary gland
- Abnormal bleeding of undetermined origin
- History of extrauterine pregnancy in the previous 3 months
- Known allergy or hypersensitivity to progesterone or to any of the excipients (including peanut oil) of the additional study medications (GnRH agonist, Ovidrel®, and Crinone 8%®)
- History of poor response to gonadotropin treatment (defined as fewer than 5 oocytes retrieved in a previous attempt)
- Any hormonal treatment within 1 month before the start of the FSH treatment, with the exception of levothyroxine)
- Egg donor
- Administration of other investigational products within the previous month
- Clinically abnormal findings at Visit 1
- Concomitant participation in another study protocol
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
Abington Reproductive Medicine
Abington, Pennsylvania, 19001
Georgia Reproductive Specialists
Atlanta, Georgia, 30342
Texas Fertility Center
Austin, Texas, 78731
Center for Assisted Reproduction
Bedford, Texas, 75022
Main Line Fertility Center
Bryn Mawr, Pennsylvania, 19010
Shady Grove Fertility RSC, Chesterbrook, PA
Chesterbrook, Pennsylvania, 19087
Fertility Centers of Illinois
Chicago, Illinois, 60610
Institute for Reproductive Health
Cincinnati, Ohio, 45209
HRC Fertility
Encino, California, 91436
In Via Fertility Specialists
Hoffman Estate, Illinois, 60169
Fertility Specialists of Houston
Houston, Texas, 77054
Houston Fertility Institute
Houston, Texas, 77063
Cooper Institute of Reproductive Hormonal Disorders, P.C.
Marlton, New Jersey, 08053
Fertility Associates of Memphis
Memphis, Tennessee, 38120
Reproductive Associates of Delaware
Newark, Delaware, 19713
Jones Institute for Reproductive Medicine
Norfolk, Virginia, 23507
University of Penn
Philadelphia, Pennsylvania, 19104
Nevada Center for Reproductive Medicine
Reno, Nevada, 89519
Shady Grove Fertility RSC
Rockville, Maryland, 20850
FL Fertility Institution
Tampa, Florida, 33759
Physicians Research Group
Tempe, Arizona, 85284
Center of Reproducitve Medicine
Webster, Texas, 77598
About this study
Official title: Phase III Investigator and Assessor Blinded 1:1 Randomized, Parallel-group Multicenter Study to Compare Efficacy and Safety of Two r-hFSH Formulations (AFOLIA vs Gonal-f® RFF) in Normal Ovulatory Women 35 to 42 Years Old Undergoing in Vitro Fertilization
The purpose of this study is to show that AFOLIA, a recombinant manufactured human follicle stimulating hormone (r-hFSH) has a similar efficacy and safety profile compared to Gonal-f® RFF.
Read the detailed description
Comparison of the clinical pregnancy rate in the AFOLIA group compared to the US approved Gonal-f® RFF Redi-ject group as the primary endpoint. Comparison of the number and size of follicles, the number of cycle cancellation, the hormone parameters and adverse events in the AFOLIA group compared to the Gonal-f® RFF group as secondary endpoints.
- Conditions
- Infertility
- Being tested
- AFOLIA, Gonal-f® RFF
- Keywords
- IVF, In vitro fertilization, Controlled ovarian stimulation, Follitropin, AFOLIA, Finox
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AFOLIADrug
Also called Follitropin-alfa
225IU subcutaneously, starting at the day of successful down-regulation for the first 5 days, followed by a treatment period with an increased dose until the point of ovulation induction has been reached
Gonal-f® RFFDrug
Also called Follitropin-alfa
225IU subcutaneously, starting at the day of successful down-regulation for the first 5 days, followed by a treatment period with an increased dose until the point of ovulation induction has been reached
| Study group | Role | What they receive |
|---|---|---|
| AFOLIA | Experimental | One subcutaneous injection of 225IU AFOLIA (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU. Receives: Drug: AFOLIA |
| Gonal-f® RFF | Active comparator | One subcutaneous injection of 225IU Gonal-f® RFF (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU. Receives: Drug: Gonal-f® RFF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Pregnancy Rate After One Cycle of Treatment - ITT Population
Clinical pregnancy was defined as presence of at least one intrauterine gestational sac and fetal heart activity as demonstrated by vaginal ultrasound at six weeks (42 +/- 1 day) post ET (Visit 11). The clinical pregnancy rate is the proportion of subjects who achieve clinical pregnancy, relative to the number of patients in the ITT population of the respective treatment arm.
Measured: Six weeks post embryo transfer
Clinical Pregnancy Rate After One Cycle of Treatment - PP Population
Clinical pregnancy was defined as presence of at least one intrauterine gestational sac and fetal heart activity as demonstrated by vaginal ultrasound at six weeks (42 +/- 1 day) post ET (Visit 11). The clinical pregnancy rate is the proportion of subjects who achieve clinical pregnancy, relative to the number of patients in the PP population of the respective treatment arm.
Measured: Six weeks post embryo transfer
Secondary outcomes (13)
Exposure to r-hFSH Injections: Days of r-hFSH Stimulation - Cycle 1
The number of days of r-hFSH stimulation a subject received during Cycle 1.
Measured: Measured at discretionary visits between Days 9 and 15 after FSH starts
Exposure to r-hFSH Injections: Total Dose of r-hFSH (IU) - Cycle 1
The total dose of r-hFSH that subjects received during Cycle 1.
Measured: Measured at discretionary visits between Days 9 and 15 after FSH starts.
Exposure to r-hFSH Injections: Daily Dose of r-hFSH (IU) - Cycle 1
The mean dose of r-hFSH that subjects received in a day during Cycle 1.
Measured: Measured at discretionary visits between Days 9 and 15 after FSH starts.
Number of Oocytes Retrieved - Cycle 1
The number of oocytes retrieved per subject, following hCG administration in Cycle 1.
Measured: Visit 8, 34-36 hours after hCG administration
Local and Systemic Adverse Events: Dermal Response to Injection - Cycle 1
Number of subjects reporting at least one dermal response to r-hFSH injection and number of subjects reporting no dermal responses.
Measured: Measure recorded in the Patient Diary which is maintained through entire FSH treatment, from FSH Start through to Day 16 after start of FSH (16 days).
Local and Systemic Adverse Events: Dermal Response to Injection by Severity - Cycle 1
Dermal response to r-hFSH injection as assessed by the investigator and categorized according to severity of reaction
Measured: Measure recorded in the Patient Diary which is maintained through entire FSH treatment, from FSH through to Day 16 after start of FSH (16 days).
Overall Summary of Adverse Events (AEs) - Cycle 1
Summary of AEs, including the number of subjects experiencing to following during Cycle 1:
At least one AE At least one treatment related AE At least one serious AE At least one AE leading to discontinuation of study drug At least one AE due to pregnancy complication
Measured: Measured from the start of FSH treatment through to either the end FSH treatment + 30 days (up to 46 days) or to the last Telephone Follow-up / Live Birth Questionnaire on pregnancy outcome (if applicable) (up to 10 months).
Adverse Events of Special Interest: Ovarian Hyperstimulation Syndrome (OHSS) - Cycle 1
Summary of the number of subjects with mild, moderate and severe OHSS. The total number of subjects with OHSS is also included.
Measured: Measured either 3 days after ooctye pick up (Visit 9) or 18 +/- 1 days after oocyte pick up (Visit 10).
Adverse Events of Special Interest: Ovarian Hyperstimulation Syndrome (OHSS) - Cycle 2
Summary of the number of subjects with mild, moderate and severe OHSS. The total number of subjects with OHSS is also included.
Measured: Measured either 3 days after ooctye pick up (Visit 9) or 18 +/- 1 days after oocyte pick up (Visit 10).
Adverse Events of Special Interest: Ovarian Hyperstimulation Syndrome (OHSS) - Cycle 3
Summary of the number of subjects with mild, moderate and severe OHSS. The total number of subjects with OHSS is also included.
Measured: Measured either 3 days after ooctye pick up (Visit 9) or 18 +/- 1 days after oocyte pick up (Visit 10).
Number of Subjects With Detectable Specific Serum Binding to FSH by Surface Plasmon Resonance - Cycle 1
Measurement of the number of subjects with detectable specific serum binding to FSH by surface Plasmon resonance during Cycle 1.
Measured: Immunogenicity samples were taken at baseline, Visit 5 (8 days after start of treatment), Visit 9 (5 days after the end of FSH treatment), Visit 10 (18 +/- 1 days after oocyte retrieval), and Visit 11 (42 +/- 1 days after embryo transfer).
Number of Subjects With Detectable Specific Serum Binding to FSH by Surface Plasmon Resonance - Cycle 2
Measurement of the number of subjects with detectable specific serum binding to FSH by surface Plasmon resonance during Cycle 2.
Measured: Immunogenicity samples were taken at baseline, Visit 5 (8 days after start of treatment), Visit 9 (5 days after the end of FSH treatment), Visit 10 (18 +/- 1 days after oocyte retrieval), and Visit 11 (42 +/- 1 days after embryo transfer).
Number of Subjects With Detectable Specific Serum Binding to FSH by Surface Plasmon Resonance - Cycle 3
Measurement of the number of subjects with detectable specific serum binding to FSH by surface Plasmon resonance during Cycle 3.
Measured: Immunogenicity samples were taken at baseline, Visit 5 (8 days after start of treatment), Visit 9 (5 days after the end of FSH treatment), Visit 10 (18 +/- 1 days after oocyte retrieval), and Visit 11 (42 +/- 1 days after embryo transfer).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2012 (estimated)
- Study start25 Nov 2013
- Primary completion10 Sep 2015
- Study completion14 Nov 2016
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 1,100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fertility Biotech AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Julian Jenkins, DM FRCOG, Study director, Fertility Biotech AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01687712
- Sponsor's protocol ID
- FIN3002
- Status last verified
- Oct 2017
- First submitted
- 3 Sep 2012
- Last updated
- 5 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Investigator and Assessor Blinded 1:1 Randomized, Parallel-group Multicenter Study to Compare Efficacy and Safety of Two r-hFSH Formulations (AFOLIA vs Gonal-f® RFF) in Normal Ovulatory Women 35 to 42 Years Old Undergoing in Vitro Fertilization
- ClinicalTrials.gov ID
- NCT01687712
- Acronym / sponsor ID
- FIN3002
- Conditions
- Infertility
- Keywords
- IVF, In vitro fertilization, Controlled ovarian stimulation, Follitropin, AFOLIA, Finox
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,100 participants (actual)
- Lead sponsor
- Fertility Biotech AGIndustry (pharma, biotech, devices)
- Study start
- 25 Nov 2013 (actual)
- Primary completion
- 10 Sep 2015 (actual)
- Study completion
- 14 Nov 2016 (actual)
- First posted
- 19 Sep 2012 (estimated)
- Results
- Posted 18 Oct 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to show that AFOLIA, a recombinant manufactured human follicle stimulating hormone (r-hFSH) has a similar efficacy and safety profile compared to Gonal-f® RFF.
Detailed description
Comparison of the clinical pregnancy rate in the AFOLIA group compared to the US approved Gonal-f® RFF Redi-ject group as the primary endpoint. Comparison of the number and size of follicles, the number of cycle cancellation, the hormone parameters and adverse events in the AFOLIA group compared to the Gonal-f® RFF group as secondary endpoints.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AFOLIA | Experimental | Drug: AFOLIAOne subcutaneous injection of 225IU AFOLIA (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU. |
| Gonal-f® RFF | Active comparator | Drug: Gonal-f® RFFOne subcutaneous injection of 225IU Gonal-f® RFF (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU. |
Who may qualify
- Ages
- 35 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 35 to 42 years of age
- Indication for controlled ovarian stimulation and IVF or intracytoplasmic sperm injection (ICSI)
- Regular menstrual cycles (25-35 days)
- History of a maximum of two fresh cycle treatments in the present series of assisted reproductive technologies (ART) at the day of first screening (thawed cycles are not subject to that criteria)
- Body mass index (BMI) ≥18 and ≤38 kg/m2
Key exclusion criteria (19 listed)
- Presence of pregnancy
- History of or active polycystic ovary syndrome (PCOS)
- AFC >20 follicles with a diameter of <11 mm (both ovaries combined) as measured on US in the early follicular phase (menstrual cycle day 2-5)
- History of >2 unsuccessful fresh ART retrieval cycles
- Presence of uncontrolled endocrine disorder
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 |
|---|---|---|
| AFOLIAAlso: Follitropin-alfa225IU subcutaneously, starting at the day of successful down-regulation for the first 5 days, followed by a treatment period with an increased dose until the point of ovulation induction has been reached | Drug | AFOLIA |
| Gonal-f® RFFAlso: Follitropin-alfa225IU subcutaneously, starting at the day of successful down-regulation for the first 5 days, followed by a treatment period with an increased dose until the point of ovulation induction has been reached | Drug | Gonal-f® RFF |
Primary outcome
Clinical Pregnancy Rate After One Cycle of Treatment - ITT Population
Time frame: Six weeks post embryo transfer
Clinical pregnancy was defined as presence of at least one intrauterine gestational sac and fetal heart activity as demonstrated by vaginal ultrasound at six weeks (42 +/- 1 day) post ET (Visit 11). The clinical pregnancy rate is the proportion of subjects who achieve clinical pregnancy, relative to the number of patients in the ITT population of the respective treatment arm.
Clinical Pregnancy Rate After One Cycle of Treatment - PP Population
Time frame: Six weeks post embryo transfer
Clinical pregnancy was defined as presence of at least one intrauterine gestational sac and fetal heart activity as demonstrated by vaginal ultrasound at six weeks (42 +/- 1 day) post ET (Visit 11). The clinical pregnancy rate is the proportion of subjects who achieve clinical pregnancy, relative to the number of patients in the PP population of the respective treatment arm.
13 secondary outcomes
Exposure to r-hFSH Injections: Days of r-hFSH Stimulation - Cycle 1
Time frame: Measured at discretionary visits between Days 9 and 15 after FSH starts
Exposure to r-hFSH Injections: Total Dose of r-hFSH (IU) - Cycle 1
Time frame: Measured at discretionary visits between Days 9 and 15 after FSH starts.
Exposure to r-hFSH Injections: Daily Dose of r-hFSH (IU) - Cycle 1
Time frame: Measured at discretionary visits between Days 9 and 15 after FSH starts.
Number of Oocytes Retrieved - Cycle 1
Time frame: Visit 8, 34-36 hours after hCG administration
Local and Systemic Adverse Events: Dermal Response to Injection - Cycle 1
Time frame: Measure recorded in the Patient Diary which is maintained through entire FSH treatment, from FSH Start through to Day 16 after start of FSH (16 days).
Local and Systemic Adverse Events: Dermal Response to Injection by Severity - Cycle 1
Time frame: Measure recorded in the Patient Diary which is maintained through entire FSH treatment, from FSH through to Day 16 after start of FSH (16 days).
Overall Summary of Adverse Events (AEs) - Cycle 1
Time frame: Measured from the start of FSH treatment through to either the end FSH treatment + 30 days (up to 46 days) or to the last Telephone Follow-up / Live Birth Questionnaire on pregnancy outcome (if applicable) (up to 10 months).
Adverse Events of Special Interest: Ovarian Hyperstimulation Syndrome (OHSS) - Cycle 1
Time frame: Measured either 3 days after ooctye pick up (Visit 9) or 18 +/- 1 days after oocyte pick up (Visit 10).
Adverse Events of Special Interest: Ovarian Hyperstimulation Syndrome (OHSS) - Cycle 2
Time frame: Measured either 3 days after ooctye pick up (Visit 9) or 18 +/- 1 days after oocyte pick up (Visit 10).
Adverse Events of Special Interest: Ovarian Hyperstimulation Syndrome (OHSS) - Cycle 3
Time frame: Measured either 3 days after ooctye pick up (Visit 9) or 18 +/- 1 days after oocyte pick up (Visit 10).
Number of Subjects With Detectable Specific Serum Binding to FSH by Surface Plasmon Resonance - Cycle 1
Time frame: Immunogenicity samples were taken at baseline, Visit 5 (8 days after start of treatment), Visit 9 (5 days after the end of FSH treatment), Visit 10 (18 +/- 1 days after oocyte retrieval), and Visit 11 (42 +/- 1 days after embryo transfer).
Number of Subjects With Detectable Specific Serum Binding to FSH by Surface Plasmon Resonance - Cycle 2
Time frame: Immunogenicity samples were taken at baseline, Visit 5 (8 days after start of treatment), Visit 9 (5 days after the end of FSH treatment), Visit 10 (18 +/- 1 days after oocyte retrieval), and Visit 11 (42 +/- 1 days after embryo transfer).
Number of Subjects With Detectable Specific Serum Binding to FSH by Surface Plasmon Resonance - Cycle 3
Time frame: Immunogenicity samples were taken at baseline, Visit 5 (8 days after start of treatment), Visit 9 (5 days after the end of FSH treatment), Visit 10 (18 +/- 1 days after oocyte retrieval), and Visit 11 (42 +/- 1 days after embryo transfer).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2017.
- 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.
Julian Jenkins, DM FRCOG study director
Fertility Biotech AG
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AFOLIA and Gonal-f® RFF in people with Infertility, run by Fertility Biotech AG at 22 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 12 inclusion and 19 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 5 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 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 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 18 Oct 2017). 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?
Clinical Pregnancy Rate After One Cycle of Treatment - ITT Population (time frame: Six weeks post embryo transfer). The study lists 2 primary outcomes in all. 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 5 Dec 2017.