A Retrospective Study in Chinese Good Prognosis Patients Undergoing Assisted Reproductive Technology (ART) Treatment (FASSION)

December 12, 2019 updated by: Merck KGaA, Darmstadt, Germany

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Guangzhou, China
        • The Third Affiliated Hospital of Guangzhou Medical University
      • Peking, China
        • Peking University Third Hospital
      • Shandong, China
        • Reproductive Hospital Affiliated to Shandong University
      • Xiangya, China
        • Reproductive & Genetic hospital Of CITIC-Xiangya

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

No older than 35 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Drug: No Intervention
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Age
Time Frame: Baseline
Baseline
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.
5 months
Implantation Rate
Time Frame: 5 months
Implantation rate = (The number of gestational sacs observed divided by the number of embryos transferred)*100
5 months
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
5 months
Incidence and Severity of Ovarian Hyperstimulation Syndrome (OHSS)
Time Frame: 5 months
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
5 months
Early Miscarriage Rate
Time Frame: 5 months
(Number of Early miscarriages/Number of clinical pregnancies)*100
5 months
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
5 months
Type of Gonadoptropin
Time Frame: 5 months
5 months
Brand of Gonadotropin
Time Frame: 5 months
5 months
Total Dose of Gonadotropin
Time Frame: 5 months
5 months
Duration of Gonadotropin Administration
Time Frame: 5 months
5 months
Cetrotide Start Day
Time Frame: up to 5 months
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)
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)
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)
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
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)
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)
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)
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)
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
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
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
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
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
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
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
on the day of observed premature LH rise (up to 5 months)
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
on the day of observed premature LH rise (up to 5 months)
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
on the day of observed premature progesterone rise (up to 5 months)
Number of Oocytes Obtained
Time Frame: 5 months
5 months
Number of Mature Metaphase II Oocytes Obtained
Time Frame: 5 months
5 months
Fertilization Rate
Time Frame: 5 months
5 months
Total Number of Embryos on Day 3/Blastocysts on Day 5
Time Frame: Day 3 and Day 5
Day 3 and Day 5
Number of Cryopreservation Embryos/Blastocysts on Day 3 or Day 5
Time Frame: Day 3, Day 5
Day 3, Day 5
Number of Embryos/Blastocysts Transferred on Day 3 or Day 5
Time Frame: Day 3, Day 5
Day 3, Day 5
Number of Good Quality Embryos/Blastocysts Transferred
Time Frame: up to 5 months
up to 5 months
Duration of Infertility
Time Frame: Baseline
Baseline
Type of Infertility
Time Frame: Baseline
Baseline
Body Mass Index (BMI)
Time Frame: Baseline
Baseline
Smoking Status
Time Frame: Baseline
Baseline
Cause of Infertility
Time Frame: Baseline
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Merck KGaA, Darmstadt, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 29, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 26, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 26, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 30, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 30, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 5, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 13, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 12, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MS200106-0004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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