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

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: Completed
• Conditions: Infertility
• Intervention / Treatment: Drug: No Intervention

• Study Type: Observational
• Enrollment (Actual): 3000

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Age		Baseline
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.	5 months
Implantation Rate	Implantation rate = (The number of gestational sacs observed divided by the number of embryos transferred)*100	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	5 months
Incidence and Severity of Ovarian Hyperstimulation Syndrome (OHSS)		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	5 months
Early Miscarriage Rate	(Number of Early miscarriages/Number of clinical pregnancies)*100	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	5 months
Type of Gonadoptropin		5 months
Brand of Gonadotropin		5 months
Total Dose of Gonadotropin		5 months
Duration of Gonadotropin Administration		5 months
Cetrotide Start Day		up to 5 months
Leading Follicle Size on the Day of Starting Cetrotide		on the day of starting Cetrotide (up to 5 months)
Serum Luteinizing Hormone (LH) Level on the Day of Starting Cetrotide		on the day of starting Cetrotide (up to 5 months)
Serum Estradiol (E2) Level on the Day of Starting Cetrotide		on the day of starting Cetrotide (up to 5 months)
Serum Luteinizing Hormone (LH), Level on the Day of Human Chorionic Gonadotropin (hCG) Triggering		5 months
Serum Estradiol (E2) Level on the Day of Human Chorionic Gonadotropin (hCG) Triggering		on the day of hCG triggering (up to 5 months)
Progesterone Level on the Day of Human Chorionic Gonadotropin (hCG) Triggering		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		on the day of hCG triggering (up to 5 months)
Endometrial Thickness on the Day of Human Chorionic Gonadotropin (hCG) Triggering		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	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	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	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	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	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	on the day of observed premature progesterone rise (up to 5 months)
Number of Oocytes Obtained		5 months
Number of Mature Metaphase II Oocytes Obtained		5 months
Fertilization Rate		5 months
Total Number of Embryos on Day 3/Blastocysts on Day 5		Day 3 and Day 5
Number of Cryopreservation Embryos/Blastocysts on Day 3 or Day 5		Day 3, Day 5
Number of Embryos/Blastocysts Transferred on Day 3 or Day 5		Day 3, Day 5
Number of Good Quality Embryos/Blastocysts Transferred		up to 5 months
Duration of Infertility		Baseline
Type of Infertility		Baseline
Body Mass Index (BMI)		Baseline
Smoking Status		Baseline
Cause of Infertility		Baseline

Collaborators and Investigators

• Sponsor: Merck KGaA, Darmstadt, Germany

Study record dates

Study Major Dates

• Study Start (Actual): August 29, 2016
• Primary Completion (Actual): April 26, 2017
• Study Completion (Actual): April 26, 2017

Study Registration Dates

• First Submitted: August 30, 2016
• First Submitted That Met QC Criteria: August 30, 2016
• First Posted (Estimate): September 5, 2016

Study Record Updates

• Last Update Posted (Actual): December 13, 2019
• Last Update Submitted That Met QC Criteria: December 12, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Infertility; Assisted reproductive technology (ART); Cetrotide
• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: MS200106-0004