InfertilityPhase 2NCT00505752
Investigation of a Long-Acting Follicle Stimulating Hormone in Infertile Women Undergoing Assisted Reproductive Technology (ART)
A Phase 2 study testing AS900672-Enriched 50 microgram (mcg), AS900672-Enriched 100 mcg and AS900672-Enriched 150 mcg in people with Infertility, run by Merck KGaA, Darmstadt, Germany at 1 site in United States.
Trial summary
This is a Phase 2, interventional, prospective, multi-center, randomized, assessor-blind, active-comparator, dose-finding study to evaluate a new investigational long-acting follicle stimulating hormone (FSH) in infertile women who are undergoing an assisted reproductive technology (ART) procedure (In vitro… Read more about this study
- Who is it for?
- Ages 18 to 36 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- AS900672-Enriched 50 microgram (mcg), AS900672-Enriched 100 mcg and AS900672-Enriched 150 mcg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 520 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Sep 2008
- Phase
- Phase 2
- 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 36 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Infertility and desire to conceive, justifying ART treatment
- Age between 18 and 36 years, inclusive, at time of informed consent
- Body mass index (BMI) 18 to 30 kilogram per square meter (kg/m^2), inclusive
- Regular spontaneous menstrual cycles of 21 to 35 days
- Presence of both ovaries
- Transvaginal ultrasound within 6 weeks and hysterosalpingogram, hysterosonogram or hysteroscopy within 2 years prior to beginning OCP treatment, showing no clinically significant uterine abnormality, which, in the Investigator's opinion, could impair embryo implantation or pregnancy continuation
Show all 15Show fewer
- Normal early follicular phase (Day 2-4) serum FSH level, according to the local laboratory
- Normal serum thyroid stimulating hormone (TSH) level, according to the local laboratory
- Papanicolaou (PAP) smear test without clinically significant abnormalities within the last 6 months prior to beginning oral contraceptive therapy,
- Negative pregnancy test prior to beginning GnRH-agonist therapy
- Male partner with semen analysis which is at least adequate for ICSI within last 6 months prior to beginning GnRH agonist therapy, according to local laboratory
- Willing and able to comply with the protocol
- Voluntary provision of written informed consent, prior to any study-related procedure that was not part of normal medical care, with the understanding that the subject could withdraw consent at any time without prejudice to her future medical care, and
- Willingness to provide follow-up information on babies born as part of this study
- For subjects recruited at PK sub-study centers, voluntary provision of written informed consent to participate in the PK sub-study
Who cannot join
- Subject who require a starting dose of FSH greater than (>) 150 international unit per day (IU/day), in the opinion of the Investigator
- Screening ultrasound demonstrating more than 12 follicles less than (<) 11 mm mean diameter in either ovary
- Two or more previous ART cycles (consecutive or not) with poor response to gonadotrophin, defined as less than or equal to (=<)3 oocytes retrieved
- Three or more previous consecutive ART cycles without a biochemical or clinical pregnancy
- Previous failure of fertilization with ICSI
- A previous ART attempt in which there were no adequate or motile sperm before or after the processing of ejaculated sperm
Show all 27Show fewer
- Previous severe OHSS
- History or presence of tumors of the hypothalamus or pituitary gland
- History or presence of ovarian, uterine or mammary cancer
- History or presence of ovarian enlargement or cyst of unknown etiology, or presence of ovarian cyst >25 mm on the day of randomization
- Presence of endometriosis Grade III - IV
- Presence of uni- or bilateral hydrosalpinx
- Abnormal gynecological bleeding of undetermined origin
- Contraindication to being pregnant and/or carrying a pregnancy to term
- History of >= 3 clinical or preclinical (absence of gestational sac) miscarriages due to any cause
- Extra-uterine pregnancy within the 3 months prior to randomization
- Clinically significant concurrent disease that would have compromised subject safety or interfered with the study assessments
- Known infection with human immunodeficiency virus (HIV), hepatitis B or C virus in the female or male partner
- Known allergy or hypersensitivity to human gonadotrophin preparations or to compounds that are structurally similar to any of the other medications administered during the study
- Any medical condition, which in the judgment of the Investigator may have interfere with the absorption, distribution, metabolism or excretion of r-hFSH
- Any active substance abuse or history of drug, medication or alcohol abuse within 5 years before screening
- ART cycle and/or ovarian stimulation within 30 days prior to informed consent
- Entered previously into this study or simultaneous participation in another clinical trial
- Subject is a smoker consuming more than 5 cigarettes per day
- In the opinion of the Investigator, either assisted hatching or pre-implantation genetic diagnosis is indicated for the subject
- Planning to undergo experimental procedures such as blastomere biopsy, or
- Any known autoimmune disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Local US Medical Information Office
Rockland, Massachusetts, 02370
About this study
Official title: A Phase II, Multicenter, Randomized, Assessor-blinded, Active-comparator, Dose-finding Study to Evaluate AS900672 Enriched Versus Follitropin Alfa (Gonal-f®) in Stimulating Multiple Follicular Development in Infertile Women Undergoing Assisted Reproductive Technology (ART)
This is a Phase 2, interventional, prospective, multi-center, randomized, assessor-blind, active-comparator, dose-finding study to evaluate a new investigational long-acting follicle stimulating hormone (FSH) in infertile women who are undergoing an assisted reproductive technology (ART) procedure (In vitro fertilization/Intra cytoplasmic sperm injection [IVF/ICSI]). This study will compare 3 doses of the investigational drug versus a currently marketed drug follitropin alfa (Gonal-f® revised formulation female [RFF] Pen) in regards to the number of fertilized oocytes.
Read the detailed description
Infertile women who are candidates for ART will be prospectively screened for enrollment at 24 clinical trial sites in the United States and Argentina. Enrolled subjects will start treatment using oral contraceptives (OCP) and will then receive a Gonadotropin releasing hormone (GnRH)-agonist (leuprolide acetate) for pituitary desensitization. Once down-regulation is achieved, the subjects will be randomized in a 1:1:1:1 ratio to begin ovarian stimulation with one of 3 doses of AS900672-Enriched or with follitropin alfa (Gonal-f®) daily injections. Subjects will be recruited to the four study arms in parallel. Beginning on S1, the subjects will receive either a single injection of AS900672-Enriched or start daily injections of follitropin alfa. The subjects' response to treatment will be monitored by ovarian ultrasound and E2 levels. On S6, subjects randomized to AS900672-Enriched may begin receiving supplemental follitropin alfa 150 IU, according to the each subject's ovarian response, and subjects randomized to follitropin alfa 150 IU daily injections will continue treatment at the same dose. Recombinant human chorionic gonadotropin (r-hCG, Ovidrel®) will be administered to subjects meeting response criteria and who are not at risk for ovarian hyperstimulation syndrome (OHSS). Oocyte retrieval will occur within 34-38 hours after r-hCG administration and subjects will begin luteal phase support using vaginal progesterone (Crinone® 8 percent or Prochieve® 8 percent) the following day. Fertilization will be done by conventional IVF or ICSI. Embryo transfer will occur in accordance with the specific requirements of each subject and the clinical trial site's standard practice, with the exception that a maximum of two embryos at the cleavage or blastocyst stage may be transferred. Subjects who undergo embryo transfer will be assessed for pregnancy and a follow-up visit will be performed 15-20 days post r-hCG administration. Subjects with a positive pregnancy test will undergo a confirmatory ultrasound evaluation at Day 35 - 42 post r-hCG. Additionally, all subjects recruited at certain trial centers will participate in a pharmacokinetic (PK) sub-study.
- Conditions
- Infertility
- Being tested
- AS900672-Enriched 50 microgram (mcg), AS900672-Enriched 100 mcg, AS900672-Enriched 150 mcg, Follitropin alfa 150 international unit (IU), Recombinant human chorionic gonadotropin (r-hCG)
- Keywords
- Assisted reproductive technology, follicle stimulating hormone
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AS900672-Enriched 50 microgram (mcg)Drug
Also called Hyperglycosylated r-hFSH
Single injection of AS900672-Enriched (hyperglycosylated recombinant human follicle stimulating hormone [r-hFSH]), 50 mcg will be administered subcutaneously on Stimulation Day 1 (S1). Duration of treatment cycle will be up to adequate follicular response or maximum of 21 days.
AS900672-Enriched 100 mcgDrug
Also called Hyperglycosylated r-hFSH
Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 100 mcg will be administered subcutaneously on S1. Duration of treatment cycle will up to adequate follicular response or maximum of 21 days.
AS900672-Enriched 150 mcgDrug
Also called Hyperglycosylated r-hFSH
Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 150 mcg will be administered subcutaneously on S1. Duration of treatment cycle will up to adequate follicular response or maximum of 21 days.
Follitropin alfa 150 international unit (IU)Drug
Also called Gonal-f®, Follicle stimulating hormone (FSH)
Follitropin alfa (Gonal-f®) 150 IU will be administered subcutaneously once daily from S1 up to Stimulation Day 21 (S21) based upon ovarian response, until recombinant human chorionic gonadotropin (r-hCG) administration day. Subjects who will be receiving AS900672-Enriched 50, 100 and 150 mcg will also receive daily dose of follitropin alfa 150 IU subcutaneously from Stimulation Day 6 (S6) up to S21. Duration of treatment cycle will be up to adequate follicular response or maximum of 21 days.
Recombinant human chorionic gonadotropin (r-hCG)Drug
Also called Ovidrel®, Choriogonadotropin alfa
Recombinant human chorionic gonadotropin (r-hCG) will be administered as a single dose of 250 mcg subcutaneously, when follicular response is adequate (that is, at least 1 follicle with a diameter of greater than or equal to [>=] 18 millimeter [mm], two or more additional follicles with a diameter of >= 16 mm, and Estradiol [E2] levels will approximately 150 picogram per milliliter [pg/mL] per mature follicle).
| Study group | Role | What they receive |
|---|---|---|
| AS900672-Enriched 50 mcg | Experimental | Not described Receives: Drug: AS900672-Enriched 50 microgram (mcg); Drug: Follitropin alfa 150 international unit (IU); Drug: Recombinant human chorionic gonadotropin (r-hCG) |
| AS900672-Enriched 100 mcg | Experimental | Not described Receives: Drug: AS900672-Enriched 100 mcg; Drug: Follitropin alfa 150 international unit (IU); Drug: Recombinant human chorionic gonadotropin (r-hCG) |
| AS900672-Enriched 150 mcg | Experimental | Not described Receives: Drug: AS900672-Enriched 150 mcg; Drug: Follitropin alfa 150 international unit (IU); Drug: Recombinant human chorionic gonadotropin (r-hCG) |
| Follitropin alfa 150 IU | Active comparator | Not described Receives: Drug: Follitropin alfa 150 international unit (IU); Drug: Recombinant human chorionic gonadotropin (r-hCG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Fertilized Oocytes (2 Pronuclei [PN])
Oocytes were fertilized using Intra-cytoplasmic Sperm Injection (ICSI) technique which is an in-vitro fertilization procedure in which a single sperm is injected directly into an egg under a microscope. The appearance of 2PN is the first sign of successful fertilization as observed during in vitro fertilization, and is usually observed after ICSI. The zygote is then termed 2PN.
Measured: Ovum pick-up (OPU) day (34-38 hours post r-hCG administration day [end of stimulation cycle {approximately 21 days}])
Secondary outcomes (1)
Percentage of Participants With Clinical Pregnancy
Clinical pregnancy was defined as the presence of one or more fetal sacs with fetal heart activity on the Day 35-42 post r-hCG ultrasound examination.
Measured: Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 21 days])
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2007 (estimated)
- Study startJan 2007
- Primary completionSep 2008
- Study completionSep 2008
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 520 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zourab Bebia, MD, Study director, EMD Serono
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00505752
- Sponsor's protocol ID
- 27591
- Status last verified
- Jan 2014
- First submitted
- 20 Jul 2007
- Last updated
- 13 Feb 2014
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Multicenter, Randomized, Assessor-blinded, Active-comparator, Dose-finding Study to Evaluate AS900672 Enriched Versus Follitropin Alfa (Gonal-f®) in Stimulating Multiple Follicular Development in Infertile Women Undergoing Assisted Reproductive Technology (ART)
- ClinicalTrials.gov ID
- NCT00505752
- Acronym / sponsor ID
- 27591
- Conditions
- Infertility
- Keywords
- Assisted reproductive technology, follicle stimulating hormone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 520 participants (actual)
- Lead sponsor
- Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
- Study start
- Jan 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 23 Jul 2007 (estimated)
- Results
- Posted 24 Jul 2013
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 2, interventional, prospective, multi-center, randomized, assessor-blind, active-comparator, dose-finding study to evaluate a new investigational long-acting follicle stimulating hormone (FSH) in infertile women who are undergoing an assisted reproductive technology (ART) procedure (In vitro fertilization/Intra cytoplasmic sperm injection [IVF/ICSI]). This study will compare 3 doses of the investigational drug versus a currently marketed drug follitropin alfa (Gonal-f® revised formulation female [RFF] Pen) in regards to the number of fertilized oocytes.
Detailed description
Infertile women who are candidates for ART will be prospectively screened for enrollment at 24 clinical trial sites in the United States and Argentina. Enrolled subjects will start treatment using oral contraceptives (OCP) and will then receive a Gonadotropin releasing hormone (GnRH)-agonist (leuprolide acetate) for pituitary desensitization. Once down-regulation is achieved, the subjects will be randomized in a 1:1:1:1 ratio to begin ovarian stimulation with one of 3 doses of AS900672-Enriched or with follitropin alfa (Gonal-f®) daily injections. Subjects will be recruited to the four study arms in parallel. Beginning on S1, the subjects will receive either a single injection of AS900672-Enriched or start daily injections of follitropin alfa. The subjects' response to treatment will be monitored by ovarian ultrasound and E2 levels. On S6, subjects randomized to AS900672-Enriched may begin receiving supplemental follitropin alfa 150 IU, according to the each subject's ovarian response, and subjects randomized to follitropin alfa 150 IU daily injections will continue treatment at the same dose. Recombinant human chorionic gonadotropin (r-hCG, Ovidrel®) will be administered to subjects meeting response criteria and who are not at risk for ovarian hyperstimulation syndrome (OHSS). Oocyte retrieval will occur within 34-38 hours after r-hCG administration and subjects will begin luteal phase support using vaginal progesterone (Crinone® 8 percent or Prochieve® 8 percent) the following day. Fertilization will be done by conventional IVF or ICSI. Embryo transfer will occur in accordance with the specific requirements of each subject and the clinical trial site's standard practice, with the exception that a maximum of two embryos at the cleavage or blastocyst stage may be transferred. Subjects who undergo embryo transfer will be assessed for pregnancy and a follow-up visit will be performed 15-20 days post r-hCG administration. Subjects with a positive pregnancy test will undergo a confirmatory ultrasound evaluation at Day 35 - 42 post r-hCG. Additionally, all subjects recruited at certain trial centers will participate in a pharmacokinetic (PK) sub-study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| AS900672-Enriched 50 mcg | Experimental | Drug: AS900672-Enriched 50 microgram (mcg), Drug: Follitropin alfa 150 international unit (IU), Drug: Recombinant human chorionic gonadotropin (r-hCG) |
| AS900672-Enriched 100 mcg | Experimental | Drug: AS900672-Enriched 100 mcg, Drug: Follitropin alfa 150 international unit (IU), Drug: Recombinant human chorionic gonadotropin (r-hCG) |
| AS900672-Enriched 150 mcg | Experimental | Drug: AS900672-Enriched 150 mcg, Drug: Follitropin alfa 150 international unit (IU), Drug: Recombinant human chorionic gonadotropin (r-hCG) |
| Follitropin alfa 150 IU | Active comparator | Drug: Follitropin alfa 150 international unit (IU), Drug: Recombinant human chorionic gonadotropin (r-hCG) |
Who may qualify
- Ages
- 18 to 36 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Infertility and desire to conceive, justifying ART treatment
- Age between 18 and 36 years, inclusive, at time of informed consent
- Body mass index (BMI) 18 to 30 kilogram per square meter (kg/m^2), inclusive
- Regular spontaneous menstrual cycles of 21 to 35 days
- Presence of both ovaries
Key exclusion criteria (27 listed)
- Subject who require a starting dose of FSH greater than (>) 150 international unit per day (IU/day), in the opinion of the Investigator
- Screening ultrasound demonstrating more than 12 follicles less than (<) 11 mm mean diameter in either ovary
- Two or more previous ART cycles (consecutive or not) with poor response to gonadotrophin, defined as less than or equal to (=<)3 oocytes retrieved
- Three or more previous consecutive ART cycles without a biochemical or clinical pregnancy
- Previous failure of fertilization with ICSI
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 |
|---|---|---|
| AS900672-Enriched 50 microgram (mcg)Also: Hyperglycosylated r-hFSHSingle injection of AS900672-Enriched (hyperglycosylated recombinant human follicle stimulating hormone [r-hFSH]), 50 mcg will be administered subcutaneously on Stimulation Day 1 (S1). Duration of treatment cycle will be up to adequate follicular response or maximum of 21 days. | Drug | AS900672-Enriched 50 mcg |
| AS900672-Enriched 100 mcgAlso: Hyperglycosylated r-hFSHSingle injection of AS900672-Enriched (hyperglycosylated r-hFSH), 100 mcg will be administered subcutaneously on S1. Duration of treatment cycle will up to adequate follicular response or maximum of 21 days. | Drug | AS900672-Enriched 100 mcg |
| AS900672-Enriched 150 mcgAlso: Hyperglycosylated r-hFSHSingle injection of AS900672-Enriched (hyperglycosylated r-hFSH), 150 mcg will be administered subcutaneously on S1. Duration of treatment cycle will up to adequate follicular response or maximum of 21 days. | Drug | AS900672-Enriched 150 mcg |
| Follitropin alfa 150 international unit (IU)Also: Gonal-f®, Follicle stimulating hormone (FSH)Follitropin alfa (Gonal-f®) 150 IU will be administered subcutaneously once daily from S1 up to Stimulation Day 21 (S21) based upon ovarian response, until recombinant human chorionic gonadotropin (r-hCG) administration day. Subjects who will be receiving AS900672-Enriched 50, 100 and 150 mcg will also receive daily dose of follitropin alfa 150 IU subcutaneously from Stimulation Day 6 (S6) up to S21. Duration of treatment cycle will be up to adequate follicular response or maximum of 21 days. | Drug | AS900672-Enriched 100 mcg, AS900672-Enriched 150 mcg, AS900672-Enriched 50 mcg, Follitropin alfa 150 IU |
| Recombinant human chorionic gonadotropin (r-hCG)Also: Ovidrel®, Choriogonadotropin alfaRecombinant human chorionic gonadotropin (r-hCG) will be administered as a single dose of 250 mcg subcutaneously, when follicular response is adequate (that is, at least 1 follicle with a diameter of greater than or equal to [>=] 18 millimeter [mm], two or more additional follicles with a diameter of >= 16 mm, and Estradiol [E2] levels will approximately 150 picogram per milliliter [pg/mL] per mature follicle). | Drug | AS900672-Enriched 100 mcg, AS900672-Enriched 150 mcg, AS900672-Enriched 50 mcg, Follitropin alfa 150 IU |
Primary outcome
Number of Fertilized Oocytes (2 Pronuclei [PN])
Time frame: Ovum pick-up (OPU) day (34-38 hours post r-hCG administration day [end of stimulation cycle {approximately 21 days}])
Oocytes were fertilized using Intra-cytoplasmic Sperm Injection (ICSI) technique which is an in-vitro fertilization procedure in which a single sperm is injected directly into an egg under a microscope. The appearance of 2PN is the first sign of successful fertilization as observed during in vitro fertilization, and is usually observed after ICSI. The zygote is then termed 2PN.
1 secondary outcome
Percentage of Participants With Clinical Pregnancy
Time frame: Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 21 days])
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Infertility
RecruitingObservational study
International Pilot Study for Dual Non-invasive Assesment of Embryo Development
Infertility
Active, not recruitingObservational study
Retrieval of Sperm From Men With Azoospermia Using Ultrasound-guided Rete Testis Aspiration
Azoospermia, Nonobstructive, Infertility, Male
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
RecruitingObservational study
Impact of Infertility on the Sexual Sphere in Couples Undergoing Assisted Reproduction
Sexual Health Quality of Life, Infertile Patients
RecruitingObservational study
Pilot Study of Discarded Blastocysts
Infertility (IVF Patients)
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.
Zourab Bebia, MD study director
EMD Serono
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AS900672-Enriched 50 microgram (mcg), AS900672-Enriched 100 mcg and AS900672-Enriched 150 mcg in people with Infertility, run by Merck KGaA, Darmstadt, Germany 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 15 inclusion and 27 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 13 Feb 2014. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 24 Jul 2013). 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?
Number of Fertilized Oocytes (2 Pronuclei [PN]) (time frame: Ovum pick-up (OPU) day (34-38 hours post r-hCG administration day [end of stimulation cycle {approximately 21 days}])). 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 13 Feb 2014.