Polycystic Ovary SyndromePhase 3NCT03773263
New Application of Sequential in Vitro Muturation System for Infertility Patients With Polycystic Ovary Syndrome
A Phase 3 study testing sequential IVM system, intracytoplasmic sperm injection (ICSI) and Thawed embryo transfer (TET) in people with Polycystic Ovary Syndrome and Infertility, run by Sun Yat-sen University at 5 sites in China.
Trial summary
Oocyte in vitro maturation (IVM) is an artificial reproductive technologies (ART) in which cumulus-oocyte complex (COC) are collected at the immature germinal vesicle (GV) stage from unstimulated or FSH-primed ovaries and matured in vitro before fertilization. Read more about this study
- Who is it for?
- Ages Up to 35 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome, Infertility
- What is being tested?
- sequential IVM system, intracytoplasmic sperm injection (ICSI) and Thawed embryo transfer (TET)
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 5 sitesChina
- Study dates
- Dec 2018to Mar 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 35 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Women age ≤35 years;
- AMH level ≥5.6ng/ml;
- Women diagnosed as PCOS according to Chinese PCOS diagnosis criteria;
- Written informed consent.
Who cannot join
- Women who diagnosed as uterus abnormality, adenomyosis, submucous myoma, intrauterine adhesion;
- Women who diagnosed as untreated hydrosalpinx;
- Women who had underwent unilateral ovariectomy;
- Women with medical condition that represent contraindication to assisted reproductive technology or pregnancy;
- Women or their partner with abnormal chromosome karyotype;
- Male partner with oligoasthenozoospermia or obstructive azoospermia;
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- Male partner whose sperm is collected by surgery;
- Subjects are found breach the inclusion criteria, or in accordance with exclusion criteria during the test, excluded;
- Patients request withdrawal and exit the trial because adverse events occur during the trial.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
The Sixth Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, 510610
Xiao-yan Liang, M.D. & Ph.D., 020-38048013, lxyzy@263.net
Reproductive medical hospital affiliated to Shandong University
Jinan, Shandong, 250001
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029
Tenth People's Hospital of Tongji University
Shanghai, 200072
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
About this study
Official title: New Application of Oocyte Sequential Culture and in Vitro Muturation System for Infertility Patients With Polycystic Ovary Syndrome: a Multi-center Prospective Randomized Clinical Trial
Oocyte in vitro maturation (IVM) is an artificial reproductive technologies (ART) in which cumulus-oocyte complex (COC) are collected at the immature germinal vesicle (GV) stage from unstimulated or FSH-primed ovaries and matured in vitro before fertilization. IVM has been proposed as a more patient-friendly ART alternative to conventional IVF. Contrary to IVF, IVM is the only ART method with no cases of OHSS reported. Hence, patients with PCOS represent the major target population for IVM treatment.
In clinical practice of standard IVM, COCs are aspirated from unstimulated or mildly stimulated ovaries and rapidly removed from the meiotic-inhibiting influence of the follicle and the follicular fluid. Regardless of in vitro gonadotrophin treatment, oocytes mature spontaneously in vitro, hence undergoing meiotic resumption in the absence of the usual elaborate cascade of endocrine and paracrine molecular signals that induce maturation in vivo. As such, the maturation of oocytes by standard IVM techniques is an artefact that compromises subsequent oocyte developmental competence. Numbers of studies have been proposed to improve the efficiency of IVM system. Synchronization of meiotic and cytoplasmic maturation in antral oocytes arrested at the immature GV-stage remains a major challenge and is of fundamental importance for successful fertilization. High intra-oocyte levels of cyclic adenosine monophosphate (cAMP), is crucial to maintain the nearly fully-grown oocytes under meiotic arrest and to induce oocyte maturation. Research in animal models has indicated that a non-physiological drop of cAMP levels in the oocyte results in asynchronous nuclear and cytoplasmic maturation.
Investigators have reported the development of a novel in vitro simulated sequential oocyte maturation system. Critical to success of the approach is a pre-IVM phase that generates a rapid increase in COC cAMP levels. Secondly, the system utilizes an extended IVM phase containing sufficient FSH to drive meiotic induction in the presence of a type-3 PDE inhibitor. The high levels of cAMP in the oocyte and the induced nature of oocyte maturation mimics some of the key, newly characterized molecular signals that occur during oocyte maturation in vivo. Technical and conceptual elements were first developed using mouse, bovine and human COCs. Investigators propose a randomized clinical trial to compare a novel sequential culture system with the traditional standard oocyte IVM system for PCOS patients.
Read the detailed description
A multi-center, prospective, randomized clinical trial will be conducted, of comparing sequential oocyte IVM system with traditional oocyte IVM system for high OHSS risk PCOS patients (AMH>5.6ng/ml). The inclusion criteria will be infertile patients diagnosed by the Chinese PCOS criteria, aged below 35 years, and without other known factors interfere reproductive or metabolic functions. 300 PCOS patients will be included and randomized into either of two groups: group A will administrate sequential oocyte IVM system and group B will administrate traditional standard oocyte IVM system. The comparison will be made between groups, and both groups are conducted with the HMG administration and embryo vitrification freezing. The primary outcome of the study is live birth rate. The embryo development and pregnancy outcomes will be followed up and compared between groups.
- Conditions
- Polycystic Ovary Syndrome, Infertility
- Being tested
- sequential IVM system, intracytoplasmic sperm injection (ICSI), Thawed embryo transfer (TET), traditional IVM system
- Keywords
- sequential IVM system, PCOS, infertility
- 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.
sequential IVM systemDrug
The immature oocytes will be cultured in sequential oocyte IVM medium 1 for 6 hours (37℃, 5% CO2). After flushed 3 times, COCs were removed into sequential oocyte IVM medium 2 for further cultivation.
intracytoplasmic sperm injection (ICSI)Procedure or surgery
intracytoplasmic sperm injection (ICSI)
Thawed embryo transfer (TET)Procedure or surgery
Patients administrates oestrogen (Progynova) 3mg twice a day for 10 to 12 days. From the day when endometrium reach a thickness of 8 mm and above, luteal phase support will be given with 10 mg progesterone (Dydrogesterone Tablets,) triple per day and utrogestan (Laboratories Besins International, Paris, France) 0.2g triple per day, until 14 days after embryo transfer.
traditional IVM systemDrug
Also called sage
COCs were aspirated and the immature oocytes will be cultured in traditional standard oocyte IVM system (Sage). 30 and 44 hours after cultivation, the maturity of oocytes will be assessed.
| Study group | Role | What they receive |
|---|---|---|
| sequential oocyte IVM group | Experimental | From day 7~9 of the menstrual cycle, 225 IU HMG (Menotrophins for Injection) per day will be administrated for 3 days. COCs were removed from aspirated follicular fluid and transferred into HEPES-buffered collection medium. The immature oocytes will be cultured in sequential IVM medium 1 for 6 hours (37℃, 5% CO2), and removed into sequential IVM medium 2 for further cultivation. After 24 and 40 hours cultivation, the mature oocytes will be fertilized by intracytoplasmic sperm injection (ICSI). Two of the D3 embryos (if available) which graded as top-quality embryo will be vitrified and the rest of embryos will be cultivated extendedly. Thawed embryo transfer (TET) will give preference to D3 embryos and carried out with a hormone replacement cycle. Receives: Drug: sequential IVM system; Procedure: intracytoplasmic sperm injection (ICSI); Procedure: Thawed embryo transfer (TET) |
| traditional oocyte IVM group | Active comparator | From day 7~9 of the menstrual cycle, 225 IU HMG (Menotrophins for Injection) per day will be administrated for 3 days. On the day of ovulation, COCs were aspirated and the immature oocytes will be cultured in traditional standard oocyte IVM system (Sage). 30 and 44 hours after cultivation, the maturity of oocytes will be assessed and the mature oocytes will be fertilized by intracytoplasmic sperm injection (ICSI). Two of the D3 embryos (if available) which graded as top-quality embryo will be vitrified and the rest of embryos will be cultivated extendedly. Thawed embryo transfer (TET) will give preference to D3 embryos and carried out with a hormone replacement cycle. If biochemical pregnancy is not achieved, thawed blastocysts transfer will be performed. Receives: Procedure: intracytoplasmic sperm injection (ICSI); Procedure: Thawed embryo transfer (TET); Drug: traditional IVM system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy rate
The fetal heart beat in an intrauterine gestational sac under ultrasound will be defined as clinical pregnancy.
Measured: 7 weeks gestation
Secondary outcomes (15)
Oocyte maturation rate
Oocyte maturation rate (%): number of MII oocytes/ number of oocytes retrieved.
Measured: 30 and 46 hours after oocyte retrieval
Fertilization rate
Fertilization rate (%): number of oocytes fertilized/ number of oocytes retrieved.
Measured: 30 and 46 hours after oocyte retrieval
Cleavage rate
Cleavage rate (%): number of cleavages/ number of 2PN embryos.
Measured: 24 hours after ICSI
Day 3 embryo rate
Day 3 embryo rate (%): number of Day 3 embryos / number of 2PN embryos.
Measured: 72 hours after ICSI
Good quality embryo rate at cleavage-stage
Good quality embryo rate at cleavage-stage (%): number of good quality embryos at cleavage-stage / number of 2PN embryos.
Measured: 72 hours after ICSI
Number of cycles with available embryo
Available embryos will be defined as three days after oocyte retrieval with containing more than 4 cells and grade 1 to 2 or containing 4 cells with a grade of 1.
Measured: 72 hours after ICSI
Blastulation rate
Blastulation rate (%): number of blastocysts / number of 2PN embryos.
Measured: 144 hours after ICSI
Biochemical pregnancy rate
A serum β-hCG level above 5 IU/L, which is performed 12 days after embryos transfer, will be defined as biochemical pregnancy.
Measured: 4 weeks gestation
Implantation rate
The implantation rate will be defined as the number of gestational sacs seen on the ultrasound divided by the total number of embryos transferred.
Measured: 7 weeks gestation
Miscarriage rate (at first trimester)
Miscarriage at first trimester will be defined by any positive pregnancy test that result in a loss of pregnancy before 12 weeks gestation.
Measured: 28 weeks gestation in maximum
Cumulative pregnancy rate
Cumulative pregnancy rate will be defined as clinical pregnancies with intrauterine fetal heart beat detected divided by the number of retrieval cycles whose embryos are all transferred.
Measured: 1-2year
Preterm birth rate
Preterm birth means the baby is born before the 37th week of pregnancy in China.
Measured: 1-2year
Newborn birth weight
Newborn birth weight
Measured: 1-2year
Neonatal complication rate
We will collect complications that occur in the neonate including admission to the neonatal intensive care unit (NICU), hospitalization, etc.
Measured: within one month after labor
Live birth rate
Live birth rate(%): number of live birth/ transferred cycle.
Measured: 1-2year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2018
- Study startDec 2018 (estimated)
- Primary completionJul 2019 (estimated)
- Study completionMar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Shandong University, The First Affiliated Hospital with Nanjing Medical University, First Affiliated Hospital of Wenzhou Medical University, Shanghai 10th People's Hospital
- Responsible party
- Principal investigator, Yanhong Deng, Sun Yat-sen University
- Investigators
- Xiao-yan Liang, M.D. & Ph.D, Study director, Sixth Affiliated Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03773263
- Sponsor's protocol ID
- newivf20181206
- Status last verified
- Dec 2018
- First submitted
- 8 Dec 2018
- Last updated
- 12 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Application of Oocyte Sequential Culture and in Vitro Muturation System for Infertility Patients With Polycystic Ovary Syndrome: a Multi-center Prospective Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03773263
- Acronym / sponsor ID
- newivf20181206
- Conditions
- Polycystic Ovary Syndrome, Infertility
- Keywords
- sequential IVM system, PCOS, infertility
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Shandong University, The First Affiliated Hospital with Nanjing Medical University, First Affiliated Hospital of Wenzhou Medical University, Shanghai 10th People's Hospital
- Study start
- Dec 2018 (estimated)
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 12 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Oocyte in vitro maturation (IVM) is an artificial reproductive technologies (ART) in which cumulus-oocyte complex (COC) are collected at the immature germinal vesicle (GV) stage from unstimulated or FSH-primed ovaries and matured in vitro before fertilization. IVM has been proposed as a more patient-friendly ART alternative to conventional IVF. Contrary to IVF, IVM is the only ART method with no cases of OHSS reported. Hence, patients with PCOS represent the major target population for IVM treatment.
In clinical practice of standard IVM, COCs are aspirated from unstimulated or mildly stimulated ovaries and rapidly removed from the meiotic-inhibiting influence of the follicle and the follicular fluid. Regardless of in vitro gonadotrophin treatment, oocytes mature spontaneously in vitro, hence undergoing meiotic resumption in the absence of the usual elaborate cascade of endocrine and paracrine molecular signals that induce maturation in vivo. As such, the maturation of oocytes by standard IVM techniques is an artefact that compromises subsequent oocyte developmental competence. Numbers of studies have been proposed to improve the efficiency of IVM system. Synchronization of meiotic and cytoplasmic maturation in antral oocytes arrested at the immature GV-stage remains a major challenge and is of fundamental importance for successful fertilization. High intra-oocyte levels of cyclic adenosine monophosphate (cAMP), is crucial to maintain the nearly fully-grown oocytes under meiotic arrest and to induce oocyte maturation. Research in animal models has indicated that a non-physiological drop of cAMP levels in the oocyte results in asynchronous nuclear and cytoplasmic maturation.
Investigators have reported the development of a novel in vitro simulated sequential oocyte maturation system. Critical to success of the approach is a pre-IVM phase that generates a rapid increase in COC cAMP levels. Secondly, the system utilizes an extended IVM phase containing sufficient FSH to drive meiotic induction in the presence of a type-3 PDE inhibitor. The high levels of cAMP in the oocyte and the induced nature of oocyte maturation mimics some of the key, newly characterized molecular signals that occur during oocyte maturation in vivo. Technical and conceptual elements were first developed using mouse, bovine and human COCs. Investigators propose a randomized clinical trial to compare a novel sequential culture system with the traditional standard oocyte IVM system for PCOS patients.
Detailed description
A multi-center, prospective, randomized clinical trial will be conducted, of comparing sequential oocyte IVM system with traditional oocyte IVM system for high OHSS risk PCOS patients (AMH>5.6ng/ml). The inclusion criteria will be infertile patients diagnosed by the Chinese PCOS criteria, aged below 35 years, and without other known factors interfere reproductive or metabolic functions. 300 PCOS patients will be included and randomized into either of two groups: group A will administrate sequential oocyte IVM system and group B will administrate traditional standard oocyte IVM system. The comparison will be made between groups, and both groups are conducted with the HMG administration and embryo vitrification freezing. The primary outcome of the study is live birth rate. The embryo development and pregnancy outcomes will be followed up and compared between groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sequential oocyte IVM group | Experimental | Drug: sequential IVM system, Procedure: intracytoplasmic sperm injection (ICSI), Procedure: Thawed embryo transfer (TET)From day 7~9 of the menstrual cycle, 225 IU HMG (Menotrophins for Injection) per day will be administrated for 3 days. COCs were removed from aspirated follicular fluid and transferred into HEPES-buffered collection medium. The immature oocytes will be cultured in sequential IVM medium 1 for 6 hours (37℃, 5% CO2), and removed into sequential IVM medium 2 for further cultivation. After 24 and 40 hours cultivation, the mature oocytes will be fertilized by intracytoplasmic sperm injection (ICSI). Two of the D3 embryos (if available) which graded as top-quality embryo will be vitrified and the rest of embryos will be cultivated extendedly. Thawed embryo transfer (TET) will give preference to D3 embryos and carried out with a hormone replacement cycle. |
| traditional oocyte IVM group | Active comparator | Procedure: intracytoplasmic sperm injection (ICSI), Procedure: Thawed embryo transfer (TET), Drug: traditional IVM systemFrom day 7~9 of the menstrual cycle, 225 IU HMG (Menotrophins for Injection) per day will be administrated for 3 days. On the day of ovulation, COCs were aspirated and the immature oocytes will be cultured in traditional standard oocyte IVM system (Sage). 30 and 44 hours after cultivation, the maturity of oocytes will be assessed and the mature oocytes will be fertilized by intracytoplasmic sperm injection (ICSI). Two of the D3 embryos (if available) which graded as top-quality embryo will be vitrified and the rest of embryos will be cultivated extendedly. Thawed embryo transfer (TET) will give preference to D3 embryos and carried out with a hormone replacement cycle. If biochemical pregnancy is not achieved, thawed blastocysts transfer will be performed. |
Who may qualify
- Ages
- Up to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Women age ≤35 years;
- AMH level ≥5.6ng/ml;
- Women diagnosed as PCOS according to Chinese PCOS diagnosis criteria;
- Written informed consent.
Key exclusion criteria (9 listed)
- Women who diagnosed as uterus abnormality, adenomyosis, submucous myoma, intrauterine adhesion;
- Women who diagnosed as untreated hydrosalpinx;
- Women who had underwent unilateral ovariectomy;
- Women with medical condition that represent contraindication to assisted reproductive technology or pregnancy;
- Women or their partner with abnormal chromosome karyotype;
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 |
|---|---|---|
| sequential IVM systemThe immature oocytes will be cultured in sequential oocyte IVM medium 1 for 6 hours (37℃, 5% CO2). After flushed 3 times, COCs were removed into sequential oocyte IVM medium 2 for further cultivation. | Drug | sequential oocyte IVM group |
| intracytoplasmic sperm injection (ICSI)intracytoplasmic sperm injection (ICSI) | Procedure or surgery | sequential oocyte IVM group, traditional oocyte IVM group |
| Thawed embryo transfer (TET)Patients administrates oestrogen (Progynova) 3mg twice a day for 10 to 12 days. From the day when endometrium reach a thickness of 8 mm and above, luteal phase support will be given with 10 mg progesterone (Dydrogesterone Tablets,) triple per day and utrogestan (Laboratories Besins International, Paris, France) 0.2g triple per day, until 14 days after embryo transfer. | Procedure or surgery | sequential oocyte IVM group, traditional oocyte IVM group |
| traditional IVM systemAlso: sageCOCs were aspirated and the immature oocytes will be cultured in traditional standard oocyte IVM system (Sage). 30 and 44 hours after cultivation, the maturity of oocytes will be assessed. | Drug | traditional oocyte IVM group |
Primary outcome
Clinical pregnancy rate
Time frame: 7 weeks gestation
The fetal heart beat in an intrauterine gestational sac under ultrasound will be defined as clinical pregnancy.
15 secondary outcomes
Oocyte maturation rate
Time frame: 30 and 46 hours after oocyte retrieval
Fertilization rate
Time frame: 30 and 46 hours after oocyte retrieval
Cleavage rate
Time frame: 24 hours after ICSI
Day 3 embryo rate
Time frame: 72 hours after ICSI
Good quality embryo rate at cleavage-stage
Time frame: 72 hours after ICSI
Number of cycles with available embryo
Time frame: 72 hours after ICSI
Blastulation rate
Time frame: 144 hours after ICSI
Biochemical pregnancy rate
Time frame: 4 weeks gestation
Implantation rate
Time frame: 7 weeks gestation
Miscarriage rate (at first trimester)
Time frame: 28 weeks gestation in maximum
Cumulative pregnancy rate
Time frame: 1-2year
Preterm birth rate
Time frame: 1-2year
Newborn birth weight
Time frame: 1-2year
Neonatal complication rate
Time frame: within one month after labor
Live birth rate
Time frame: 1-2year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2018.
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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.
Xiao-yan Liang, M.D. & Ph.D study director
Sixth Affiliated Hospital, Sun Yat-sen University
5 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 sequential IVM system, intracytoplasmic sperm injection (ICSI) and Thawed embryo transfer (TET) in people with Polycystic Ovary Syndrome and Infertility, run by Sun Yat-sen University at 5 sites in China.
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 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiao-yan Liang, M.D. & Ph.D (020-38048013, lxyzy@263.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical pregnancy rate (time frame: 7 weeks gestation). 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 12 Dec 2018.