Clinical trial NCT02889380: A Retrospective Study in Chinese Good Prognosis Patients Undergoing Assisted Reproductive Technology (ART) Treatment
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility
Keywords: Infertility
Cetrotide
Assisted reproductive technology (ART)
Lead sponsor: Merck KGaA, Darmstadt, Germany
Sponsor class: INDUSTRY
First posted: 2016-09-05
Enrollment: 3000
Sex: FEMALE
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
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.

Brief 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 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.


Eligibility criteria: 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

Primary outcomes:
measure: Clinical Pregnancy Rate
timeFrame: 5 months
measure: Implantation Rate
timeFrame: 5 months
measure: Ongoing Pregnancy Rate
timeFrame: 5 months
measure: Incidence and Severity of Ovarian Hyperstimulation Syndrome (OHSS)
timeFrame: 5 months
measure: Cycle Cancelled Rate
timeFrame: 5 months
measure: Early Miscarriage Rate
timeFrame: 5 months
measure: Live Birth Rate
timeFrame: 5 months
measure: Type of Gonadoptropin
timeFrame: 5 months
measure: Brand of Gonadotropin
timeFrame: 5 months
measure: Total Dose of Gonadotropin
timeFrame: 5 months
measure: Duration of Gonadotropin Administration
timeFrame: 5 months
measure: Cetrotide Start Day
timeFrame: up to 5 months
measure: Leading Follicle Size on the Day of Starting Cetrotide
timeFrame: on the day of starting Cetrotide (up to 5 months)
measure: Serum Luteinizing Hormone (LH) Level on the Day of Starting Cetrotide
timeFrame: on the day of starting Cetrotide (up to 5 months)
measure: Serum Estradiol (E2) Level on the Day of Starting Cetrotide
timeFrame: on the day of starting Cetrotide (up to 5 months)
measure: Serum Luteinizing Hormone (LH), Level on the Day of Human Chorionic Gonadotropin (hCG) Triggering
timeFrame: 5 months
measure: Serum Estradiol (E2) Level on the Day of Human Chorionic Gonadotropin (hCG) Triggering
timeFrame: on the day of hCG triggering (up to 5 months)
measure: Progesterone Level on the Day of Human Chorionic Gonadotropin (hCG) Triggering
timeFrame: on the day of hCG triggering (up to 5 months)
measure: Number of Follicles With Size 14 milimeter (mm) or More on the Day of Human Chorionic Gonadotropin (hCG) Triggering
timeFrame: on the day of hCG triggering (up to 5 months)
measure: Endometrial Thickness on the Day of Human Chorionic Gonadotropin (hCG) Triggering
timeFrame: on the day of hCG triggering (up to 5 months)
measure: Serum Luteinizing Hormone (LH) Level on the Day of Observed Premature Luteinizing Hormone (LH) Rise
timeFrame: on the day of observed premature LH rise (up to 5 months)
measure: Serum Estradiol (E2) Level on the Day of Observed Premature Luteinizing Hormone (LH) Rise
timeFrame: on the day of observed premature LH rise (up to 5 months)
measure: Serum Progesterone Level on the Day of Observed Premature Luteinizing Hormone (LH) Rise
timeFrame: on the day of observed premature LH rise (up to 5 months)
measure: Number of Follicles With Size 14 mm or More on the Day of Observed Premature Luteinizing Hormone (LH) Rise
timeFrame: on the day of observed premature LH rise (up to 5 months)
measure: Endometrial Thickness on the Day of Observed Premature Luteinizing Hormone (LH) Rise
timeFrame: on the day of observed premature LH rise (up to 5 months)
measure: Serum Progesterone Level on the Day of Observed Premature Progesterone Rise
timeFrame: on the day of observed premature progesterone rise (up to 5 months)
measure: Number of Oocytes Obtained
timeFrame: 5 months
measure: Number of Mature Metaphase II Oocytes Obtained
timeFrame: 5 months
measure: Fertilization Rate
timeFrame: 5 months
measure: Total Number of Embryos on Day 3/Blastocysts on Day 5
timeFrame: Day 3 and Day 5
measure: Number of Cryopreservation Embryos/Blastocysts on Day 3 or Day 5
timeFrame: Day 3, Day 5
measure: Number of Embryos/Blastocysts Transferred on Day 3 or Day 5
timeFrame: Day 3, Day 5
measure: Number of Good Quality Embryos/Blastocysts Transferred
timeFrame: up to 5 months
measure: Age
timeFrame: Baseline
measure: Duration of Infertility
timeFrame: Baseline
measure: Type of Infertility
timeFrame: Baseline
measure: Body Mass Index (BMI)
timeFrame: Baseline
measure: Smoking Status
timeFrame: Baseline
measure: Cause of Infertility
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The Third Affiliated Hospital of Guangzhou Medical University
city: Peking
country: China
facility: Peking University Third Hospital
city: Shandong
country: China
facility: Reproductive Hospital Affiliated to Shandong University
city: Xiangya
country: China
facility: Reproductive & Genetic hospital of CITIC-XIANGYA
Study officials:
affiliation: Merck Serono Co., Ltd., China
name: Medical Responsible
role: STUDY_DIRECTOR
References: