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

Infertility Clinical Trial

— FASSION  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02889380
• Other study ID #: MS200106-0004
• Status: Completed
• Start date: August 29, 2016
• Est. completion date: April 26, 2017

Study information

• Verified date: December 2019
• Source: Merck KGaA, Darmstadt, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3000
• Est. completion date: April 26, 2017
• Est. primary completion date: April 26, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility

Intervention

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.

Locations

Country	Name	City	State
China	The Third Affiliated Hospital of Guangzhou Medical University	Guangzhou
China	Peking University Third Hospital	Peking
China	Reproductive Hospital Affiliated to Shandong University	Shandong
China	Reproductive & Genetic hospital of CITIC-XIANGYA	Xiangya

Sponsors (1)

Lead Sponsor	Collaborator
Merck KGaA, Darmstadt, Germany

Country where clinical trial is conducted

China, 

Outcome

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