InfertilityFASSIONNCT02889380
A Retrospective Study in Chinese Good Prognosis Patients Undergoing Assisted Reproductive Technology (ART) Treatment
An observational study of Infertility, run by Merck KGaA, Darmstadt, Germany at 4 sites in China.
Trial summary
This is a multicenter retrospective study in good prognosis Chinese patients. Data will be collected from infertile women who underwent first in vitro fertilization (IVF)/intra cytoplasmic sperm injection (ICSI) using a Gonadotropin releasing hormone (GnRH) antagonist (Cetrotide) protocol at about 4 IVF centers to… Read more about this study
- Who is it for?
- Ages Up to 35 years, women only
- Conditions the study is for
- Infertility
- Type of treatment
- Injection or infusion
- How many people
- 3,000 participants
- Where
- 4 sitesChina
- Study dates
- 29 Aug 2016to 26 Apr 2017
- Phase
- Observational
- 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
Study population: Infertile Chinese women who underwent the first Gonadotropin releasing hormone (GnRH) antagonist in vitro fertilization (IVF)/intra cytoplasmic sperm injection - Embryo Transfer (ICSI-ET) cycle with an available assisted reproductive technology (ART) outcome.
Who may be able to join
- Infertile women who underwent the first GnRH antagonist IVF/ICSI-ET (Embryo Transfer) cycle with an available ART outcome
- Used Cetrotide in a fixed or flexible antagonist protocol
- Age not more than 35 years old
- Baseline serum Follicle-stimulating hormone (FSH) level not more than 10 milliinternational unit per milliliter (mIU/ml)
- Body mass index (BMI) not more than 30 kilogram per meter square (kg/m^2)
- Normal uterine cavity
Who cannot join
- Previously underwent 3 or more IVF/ICSI cycles
- The total dose of Gonadotropin used was more than 2500 IU in current cycle
- Administration of daily 0.125 milligram (mg) Cetrotide
- Received an agonist trigger
- Use of clomiphene citrate or letrozole during cycles
- Presence of endometriosis Grade 3 to 4, confirmed or suspected
- Presence of uni-or-bilateral hydrosalpinx
- Known history of recurrent miscarriages
Trial locations and contacts
4 sites in 1 country.
China4 sites
Peking University Third Hospital
Beijing
The Third Affiliated Hospital of Guangzhou Medical University
Guangzhou
Reproductive Hospital Affiliated to Shandong University
Shandong
Reproductive & Genetic hospital of CITIC-XIANGYA
Xiangya
About this study
Official title: A Retrospective Study in Chinese Good Prognosis Patients Undergoing ART Treatment to Investigate the Factors Associated With the Pregnancy Outcome of GnRH Antagonist IVF/ICSI Cycles
This is a multicenter retrospective study in good prognosis Chinese patients. Data will be collected from infertile women who underwent first in vitro fertilization (IVF)/intra cytoplasmic sperm injection (ICSI) using a Gonadotropin releasing hormone (GnRH) antagonist (Cetrotide) protocol at about 4 IVF centers to investigate the factors associated with clinical pregnancy rate. The definition of the good prognosis subjects is, age not more than 35 years old, Baseline serum Follicle-stimulating hormone (FSH) level no more than 10 milliinternational units (mIU)/milliliter (ml), Body mass index (BMI) not more than 30 kilogram per meter square (kg/m^2), previously underwent no more than 3 IVF/ICSI cycles, and the total dose of Gonadotropin used no more than 2500 IU in current cycle. No intervention(s) will be administered on the subjects. Data required to investigate the factors associated with the pregnancy outcome of GnRH antagonist IVF cycle will be collected from the subjects' medical records into database through electronic data capture system and analyzed.
- Conditions
- Infertility
- Being tested
- No Intervention
- Keywords
- Infertility, Cetrotide, Assisted reproductive technology (ART)
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionDrug
This study will retrospectively collect the data from the subjects who had been treated with 0.25 mg of Cetrotide injection daily in a fixed or flexible antagonist protocol with an available ART outcome.
| Study group | Role | What they receive |
|---|---|---|
| Cetrotide | This study will retrospectively collect the data from the subjects who had been treated with 0.25 milligram (mg) of Cetrotide injection daily in a fixed or flexible antagonist protocol with an available assisted reproductive technology (ART) outcome. Receives: Drug: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Pregnancy Rate
Number of clinical pregnancies expressed per 100 initiated cycles, aspiration cycles, and embryo transfer cycles. Initiated cycle: an assisted reproductive technology (ART) cycle in which the woman receives specific medication for ovarian stimulation, or monitoring in the case of natural cycles, with the intention to treat, irrespective of whether or not follicular aspiration is attempted. Aspiration cycle Initiated ART cycle in which one or more follicles are punctured and aspirated irrespective of whether or not oocytes are retrieved. Embryo transfer cycle: an ART cycle in which one or more embryos are transferred into the uterus or fallopian tube.
Measured: 5 months
Implantation Rate
Implantation rate = (The number of gestational sacs observed divided by the number of embryos transferred)*100
Measured: 5 months
Ongoing Pregnancy Rate
Ongoing pregnancy rate per embryo transfer cycles = (Number of Ongoing pregnancy/Number of embryo transfer cycles)*100 and ongoing pregnancy rate per initiated cycles = (Number of Ongoing pregnancy/Number of initiated cycles) *100
Measured: 5 months
Incidence and Severity of Ovarian Hyperstimulation Syndrome (OHSS)
Measured: 5 months
Cycle Cancelled Rate
Cycle cancelled rate = (Number of subjects with terminated in vitro fertilization (IVF) or intra cytoplasmic sperm injection (ICSI) treatment/Number of initiated cycles)*100
Measured: 5 months
Early Miscarriage Rate
(Number of Early miscarriages/Number of clinical pregnancies)*100
Measured: 5 months
Live Birth Rate
Number of live births expressed per 100 initiated cycles, aspiration cycles or embryo transfer cycles. When delivery rates are given, the denominator (initiated, aspirated, or embryo transfer cycles) will be specified
Measured: 5 months
Type of Gonadoptropin
Measured: 5 months
Brand of Gonadotropin
Measured: 5 months
Total Dose of Gonadotropin
Measured: 5 months
Duration of Gonadotropin Administration
Measured: 5 months
Cetrotide Start Day
Measured: up to 5 months
Leading Follicle Size on the Day of Starting Cetrotide
Measured: on the day of starting Cetrotide (up to 5 months)
Serum Luteinizing Hormone (LH) Level on the Day of Starting Cetrotide
Measured: on the day of starting Cetrotide (up to 5 months)
Serum Estradiol (E2) Level on the Day of Starting Cetrotide
Measured: on the day of starting Cetrotide (up to 5 months)
Serum Luteinizing Hormone (LH), Level on the Day of Human Chorionic Gonadotropin (hCG) Triggering
Measured: 5 months
Serum Estradiol (E2) Level on the Day of Human Chorionic Gonadotropin (hCG) Triggering
Measured: on the day of hCG triggering (up to 5 months)
Progesterone Level on the Day of Human Chorionic Gonadotropin (hCG) Triggering
Measured: on the day of hCG triggering (up to 5 months)
Number of Follicles With Size 14 milimeter (mm) or More on the Day of Human Chorionic Gonadotropin (hCG) Triggering
Measured: on the day of hCG triggering (up to 5 months)
Endometrial Thickness on the Day of Human Chorionic Gonadotropin (hCG) Triggering
Measured: on the day of hCG triggering (up to 5 months)
Serum Luteinizing Hormone (LH) Level on the Day of Observed Premature Luteinizing Hormone (LH) Rise
Subjects will be characterized as having a premature LH rise if any measured LH value during follicular recruitment will more than (>) 10 International Units Per Litre (IU/L) up to and including the day of the trigger
Measured: on the day of observed premature LH rise (up to 5 months)
Serum Estradiol (E2) Level on the Day of Observed Premature Luteinizing Hormone (LH) Rise
Subjects will be characterized as having a premature LH rise if any measured LH value during follicular recruitment will more than (>) 10 International Units Per Litre (IU/L) up to and including the day of the trigger
Measured: on the day of observed premature LH rise (up to 5 months)
Serum Progesterone Level on the Day of Observed Premature Luteinizing Hormone (LH) Rise
Subjects will be characterized as having a premature LH rise if any measured LH value during follicular recruitment will more than (>) 10 International Units Per Litre (IU/L) up to and including the day of the trigger
Measured: on the day of observed premature LH rise (up to 5 months)
Number of Follicles With Size 14 mm or More on the Day of Observed Premature Luteinizing Hormone (LH) Rise
Subjects will be characterized as having a premature LH rise if any measured LH value during follicular recruitment will more than (>) 10 International Units Per Litre (IU/L) up to and including the day of the trigger
Measured: on the day of observed premature LH rise (up to 5 months)
Endometrial Thickness on the Day of Observed Premature Luteinizing Hormone (LH) Rise
Subjects will be characterized as having a premature LH rise if any measured LH value during follicular recruitment will more than (>) 10 International Units Per Litre (IU/L) up to and including the day of the trigger
Measured: on the day of observed premature LH rise (up to 5 months)
Serum Progesterone Level on the Day of Observed Premature Progesterone Rise
Premature progesterone rise: A rise in serum progesterone levels above 1.5 nanogram/milliliter (ng/ml) towards the end of the follicular phase up to and including the day of the trigger
Measured: on the day of observed premature progesterone rise (up to 5 months)
Number of Oocytes Obtained
Measured: 5 months
Number of Mature Metaphase II Oocytes Obtained
Measured: 5 months
Fertilization Rate
Measured: 5 months
Total Number of Embryos on Day 3/Blastocysts on Day 5
Measured: Day 3 and Day 5
Number of Cryopreservation Embryos/Blastocysts on Day 3 or Day 5
Measured: Day 3, Day 5
Number of Embryos/Blastocysts Transferred on Day 3 or Day 5
Measured: Day 3, Day 5
Number of Good Quality Embryos/Blastocysts Transferred
Measured: up to 5 months
Age
Measured: Baseline
Duration of Infertility
Measured: Baseline
Type of Infertility
Measured: Baseline
Body Mass Index (BMI)
Measured: Baseline
Smoking Status
Measured: Baseline
Cause of Infertility
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2016 (estimated)
- Study start29 Aug 2016
- Primary completion26 Apr 2017
- Study completion26 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 3,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Responsible, Study director, Merck Serono Co., Ltd., China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02889380
- Sponsor's protocol ID
- MS200106-0004
- Acronym
- FASSION
- Status last verified
- Dec 2019
- First submitted
- 30 Aug 2016
- Last updated
- 13 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Study in Chinese Good Prognosis Patients Undergoing ART Treatment to Investigate the Factors Associated With the Pregnancy Outcome of GnRH Antagonist IVF/ICSI Cycles
- ClinicalTrials.gov ID
- NCT02889380
- Acronym / sponsor ID
- FASSION / MS200106-0004
- Conditions
- Infertility
- Keywords
- Infertility, Cetrotide, Assisted reproductive technology (ART)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,000 participants (actual)
- Lead sponsor
- Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
- Study start
- 29 Aug 2016 (actual)
- Primary completion
- 26 Apr 2017 (actual)
- Study completion
- 26 Apr 2017 (actual)
- First posted
- 5 Sep 2016 (estimated)
- 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.
This is a multicenter retrospective study in good prognosis Chinese patients. Data will be collected from infertile women who underwent first in vitro fertilization (IVF)/intra cytoplasmic sperm injection (ICSI) using a Gonadotropin releasing hormone (GnRH) antagonist (Cetrotide) protocol at about 4 IVF centers to investigate the factors associated with clinical pregnancy rate. The definition of the good prognosis subjects is, age not more than 35 years old, Baseline serum Follicle-stimulating hormone (FSH) level no more than 10 milliinternational units (mIU)/milliliter (ml), Body mass index (BMI) not more than 30 kilogram per meter square (kg/m^2), previously underwent no more than 3 IVF/ICSI cycles, and the total dose of Gonadotropin used no more than 2500 IU in current cycle. No intervention(s) will be administered on the subjects. Data required to investigate the factors associated with the pregnancy outcome of GnRH antagonist IVF cycle will be collected from the subjects' medical records into database through electronic data capture system and analyzed.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cetrotide | – | Drug: No InterventionThis study will retrospectively collect the data from the subjects who had been treated with 0.25 milligram (mg) of Cetrotide injection daily in a fixed or flexible antagonist protocol with an available assisted reproductive technology (ART) outcome. |
Who may qualify
- Ages
- Up to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Infertile Chinese women who underwent the first Gonadotropin releasing hormone (GnRH) antagonist in vitro fertilization (IVF)/intra cytoplasmic sperm injection - Embryo Transfer (ICSI-ET) cycle with an available assisted reproductive technology (ART) outcome.
Key inclusion criteria (6 listed)
- Infertile women who underwent the first GnRH antagonist IVF/ICSI-ET (Embryo Transfer) cycle with an available ART outcome
- Used Cetrotide in a fixed or flexible antagonist protocol
- Age not more than 35 years old
- Baseline serum Follicle-stimulating hormone (FSH) level not more than 10 milliinternational unit per milliliter (mIU/ml)
- Body mass index (BMI) not more than 30 kilogram per meter square (kg/m^2)
Key exclusion criteria (8 listed)
- Previously underwent 3 or more IVF/ICSI cycles
- The total dose of Gonadotropin used was more than 2500 IU in current cycle
- Administration of daily 0.125 milligram (mg) Cetrotide
- Received an agonist trigger
- Use of clomiphene citrate or letrozole during cycles
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 |
|---|---|---|
| No InterventionThis study will retrospectively collect the data from the subjects who had been treated with 0.25 mg of Cetrotide injection daily in a fixed or flexible antagonist protocol with an available ART outcome. | Drug | Cetrotide |
Primary outcome
Clinical Pregnancy Rate
Time frame: 5 months
Number of clinical pregnancies expressed per 100 initiated cycles, aspiration cycles, and embryo transfer cycles. Initiated cycle: an assisted reproductive technology (ART) cycle in which the woman receives specific medication for ovarian stimulation, or monitoring in the case of natural cycles, with the intention to treat, irrespective of whether or not follicular aspiration is attempted. Aspiration cycle Initiated ART cycle in which one or more follicles are punctured and aspirated irrespective of whether or not oocytes are retrieved. Embryo transfer cycle: an ART cycle in which one or more embryos are transferred into the uterus or fallopian tube.
Implantation Rate
Time frame: 5 months
Implantation rate = (The number of gestational sacs observed divided by the number of embryos transferred)*100
Ongoing Pregnancy Rate
Time frame: 5 months
Ongoing pregnancy rate per embryo transfer cycles = (Number of Ongoing pregnancy/Number of embryo transfer cycles)*100 and ongoing pregnancy rate per initiated cycles = (Number of Ongoing pregnancy/Number of initiated cycles) *100
Incidence and Severity of Ovarian Hyperstimulation Syndrome (OHSS)
Time frame: 5 months
Cycle Cancelled Rate
Time frame: 5 months
Cycle cancelled rate = (Number of subjects with terminated in vitro fertilization (IVF) or intra cytoplasmic sperm injection (ICSI) treatment/Number of initiated cycles)*100
Early Miscarriage Rate
Time frame: 5 months
(Number of Early miscarriages/Number of clinical pregnancies)*100
Live Birth Rate
Time frame: 5 months
Number of live births expressed per 100 initiated cycles, aspiration cycles or embryo transfer cycles. When delivery rates are given, the denominator (initiated, aspirated, or embryo transfer cycles) will be specified
Type of Gonadoptropin
Time frame: 5 months
Brand of Gonadotropin
Time frame: 5 months
Total Dose of Gonadotropin
Time frame: 5 months
Duration of Gonadotropin Administration
Time frame: 5 months
Cetrotide Start Day
Time frame: up to 5 months
Leading Follicle Size on the Day of Starting Cetrotide
Time frame: on the day of starting Cetrotide (up to 5 months)
Serum Luteinizing Hormone (LH) Level on the Day of Starting Cetrotide
Time frame: on the day of starting Cetrotide (up to 5 months)
Serum Estradiol (E2) Level on the Day of Starting Cetrotide
Time frame: on the day of starting Cetrotide (up to 5 months)
Serum Luteinizing Hormone (LH), Level on the Day of Human Chorionic Gonadotropin (hCG) Triggering
Time frame: 5 months
Serum Estradiol (E2) Level on the Day of Human Chorionic Gonadotropin (hCG) Triggering
Time frame: on the day of hCG triggering (up to 5 months)
Progesterone Level on the Day of Human Chorionic Gonadotropin (hCG) Triggering
Time frame: on the day of hCG triggering (up to 5 months)
Number of Follicles With Size 14 milimeter (mm) or More on the Day of Human Chorionic Gonadotropin (hCG) Triggering
Time frame: on the day of hCG triggering (up to 5 months)
Endometrial Thickness on the Day of Human Chorionic Gonadotropin (hCG) Triggering
Time frame: on the day of hCG triggering (up to 5 months)
Serum Luteinizing Hormone (LH) Level on the Day of Observed Premature Luteinizing Hormone (LH) Rise
Time frame: on the day of observed premature LH rise (up to 5 months)
Subjects will be characterized as having a premature LH rise if any measured LH value during follicular recruitment will more than (>) 10 International Units Per Litre (IU/L) up to and including the day of the trigger
Serum Estradiol (E2) Level on the Day of Observed Premature Luteinizing Hormone (LH) Rise
Time frame: on the day of observed premature LH rise (up to 5 months)
Subjects will be characterized as having a premature LH rise if any measured LH value during follicular recruitment will more than (>) 10 International Units Per Litre (IU/L) up to and including the day of the trigger
Serum Progesterone Level on the Day of Observed Premature Luteinizing Hormone (LH) Rise
Time frame: on the day of observed premature LH rise (up to 5 months)
Subjects will be characterized as having a premature LH rise if any measured LH value during follicular recruitment will more than (>) 10 International Units Per Litre (IU/L) up to and including the day of the trigger
Number of Follicles With Size 14 mm or More on the Day of Observed Premature Luteinizing Hormone (LH) Rise
Time frame: on the day of observed premature LH rise (up to 5 months)
Subjects will be characterized as having a premature LH rise if any measured LH value during follicular recruitment will more than (>) 10 International Units Per Litre (IU/L) up to and including the day of the trigger
Endometrial Thickness on the Day of Observed Premature Luteinizing Hormone (LH) Rise
Time frame: on the day of observed premature LH rise (up to 5 months)
Subjects will be characterized as having a premature LH rise if any measured LH value during follicular recruitment will more than (>) 10 International Units Per Litre (IU/L) up to and including the day of the trigger
Serum Progesterone Level on the Day of Observed Premature Progesterone Rise
Time frame: on the day of observed premature progesterone rise (up to 5 months)
Premature progesterone rise: A rise in serum progesterone levels above 1.5 nanogram/milliliter (ng/ml) towards the end of the follicular phase up to and including the day of the trigger
Number of Oocytes Obtained
Time frame: 5 months
Number of Mature Metaphase II Oocytes Obtained
Time frame: 5 months
Fertilization Rate
Time frame: 5 months
Total Number of Embryos on Day 3/Blastocysts on Day 5
Time frame: Day 3 and Day 5
Number of Cryopreservation Embryos/Blastocysts on Day 3 or Day 5
Time frame: Day 3, Day 5
Number of Embryos/Blastocysts Transferred on Day 3 or Day 5
Time frame: Day 3, Day 5
Number of Good Quality Embryos/Blastocysts Transferred
Time frame: up to 5 months
Age
Time frame: Baseline
Duration of Infertility
Time frame: Baseline
Type of Infertility
Time frame: Baseline
Body Mass Index (BMI)
Time frame: Baseline
Smoking Status
Time frame: Baseline
Cause of Infertility
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2019.
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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 Responsible study director
Merck Serono Co., Ltd., China
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, run by Merck KGaA, Darmstadt, Germany at 4 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 6 inclusion and 8 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 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (time frame: 5 months). The study lists 39 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 13 Dec 2019.