A Retrospective Study in Chinese Good Prognosis Patients Undergoing Assisted Reproductive Technology (ART) Treatment
- Registration Number
- NCT02889380
- Lead Sponsor
- Merck KGaA, Darmstadt, Germany
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 3000
- 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
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Cetrotide No Intervention 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.
- Primary Outcome Measures
Name Time Method Total Number of Embryos on Day 3/Blastocysts on Day 5 Day 3 and Day 5 Age Baseline Duration of Infertility Baseline Type of Infertility Baseline 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 Clinical Pregnancy Rate 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.
Live Birth Rate 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
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 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) Early Miscarriage Rate 5 months (Number of Early miscarriages/Number of clinical pregnancies)\*100
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 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) Serum Luteinizing Hormone (LH) Level on the Day of Observed Premature Luteinizing Hormone (LH) Rise 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
Number of Mature Metaphase II Oocytes Obtained 5 months Fertilization Rate 5 months Leading Follicle Size on the Day of Starting Cetrotide on the day of starting Cetrotide (up to 5 months) Total Dose of Gonadotropin 5 months Duration of Gonadotropin Administration 5 months Number of Cryopreservation Embryos/Blastocysts on Day 3 or Day 5 Day 3, Day 5 Smoking Status Baseline Cause of Infertility Baseline Endometrial Thickness on the Day of Observed Premature Luteinizing Hormone (LH) Rise 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
Serum Progesterone Level on the Day of Observed Premature Progesterone Rise 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
Ongoing Pregnancy Rate 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
Brand of Gonadotropin 5 months Cetrotide Start Day up to 5 months Number of Oocytes Obtained 5 months Body Mass Index (BMI) Baseline Implantation Rate 5 months Implantation rate = (The number of gestational sacs observed divided by the number of embryos transferred)\*100
Incidence and Severity of Ovarian Hyperstimulation Syndrome (OHSS) 5 months Cycle Cancelled Rate 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
Type of Gonadoptropin 5 months Progesterone Level on the Day of Human Chorionic Gonadotropin (hCG) Triggering on the day of hCG triggering (up to 5 months) Serum Estradiol (E2) Level on the Day of Observed Premature Luteinizing Hormone (LH) Rise 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
Serum Progesterone Level on the Day of Observed Premature Luteinizing Hormone (LH) Rise 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
Number of Follicles With Size 14 mm or More on the Day of Observed Premature Luteinizing Hormone (LH) Rise 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (4)
The Third Affiliated Hospital of Guangzhou Medical University
🇨🇳Guangzhou, China
Reproductive Hospital Affiliated to Shandong University
🇨🇳Shandong, China
Peking University Third Hospital
🇨🇳Peking, China
Reproductive & Genetic hospital of CITIC-XIANGYA
🇨🇳Xiangya, China