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

NCT02889380 | Completed

• 1 other identifier: MS200106-0004
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 4

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.

Conditions

Infertility

Keywords

Infertility; Cetrotide; Assisted reproductive technology (ART)

Outcome Measures

Primary Outcomes (39)

• 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

• Age

  Baseline

• Duration of Infertility

  Baseline

• Type of Infertility

  Baseline

• Body Mass Index (BMI)

  Baseline

• Smoking Status

  Baseline

• Cause of Infertility

  Baseline

Study Arms (1)

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

Interventions

No Intervention DRUG

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.

Cetrotide

Eligibility Criteria

• Age: Up to 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck KGaA, Darmstadt, Germany: lead

Study Sites (4)

Peking University Third Hospital

Beijing, China

Location

The Third Affiliated Hospital of Guangzhou Medical University

Guangzhou, China

Location

Reproductive Hospital Affiliated to Shandong University

Shandong, China

Location

Reproductive & Genetic hospital of CITIC-XIANGYA

Xiangya, China

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Medical Responsible

  Merck Serono Co., Ltd., China

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2016
• First Posted: September 5, 2016
• Study Start: August 29, 2016
• Primary Completion: April 26, 2017
• Study Completion: April 26, 2017
• Last Updated: December 13, 2019

Record last verified: 2019-12

Locations

CN (4)