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.
A Retrospective Study in Chinese Good Prognosis Patients Undergoing Assisted Reproductive Technology (ART) Treatment
Status
Completed
Phase
Not applicable
Enrollment
3,000
Locations
4
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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.
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
Sep 5, 2016
Study start
Aug 29, 2016
Primary completion
Apr 26, 2017
Study completion
Apr 26, 2017
Results posted
Not reported
Registry updated
Dec 13, 2019
Outcomes
What the study measures.
Primary outcomes
Clinical Pregnancy Rate
Time frame · 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.
Implantation Rate
Time frame · 5 months
Implantation rate = (The number of gestational sacs observed divided by the number of embryos transferred)\*100
Ongoing Pregnancy Rate
Time frame · 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
Incidence and Severity of Ovarian Hyperstimulation Syndrome (OHSS)
Time frame · 5 months
Cycle Cancelled Rate
Time frame · 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
Early Miscarriage Rate
Time frame · 5 months
(Number of Early miscarriages/Number of clinical pregnancies)\*100
Live Birth Rate
Time frame · 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
Type of Gonadoptropin
Time frame · 5 months
Secondary outcomes
Not reported in the indexed record.
Eligibility
Who can take part.
- Minimum age
- Not reported
- Maximum age
- 35 Years
- Sex
- FEMALE
- Healthy volunteers
- No
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 locations
4 registered sites.
China. Showing up to 24 locations stored in the fast local snapshot.
Peking University Third Hospital
Beijing, China
The Third Affiliated Hospital of Guangzhou Medical University
Guangzhou, China
Reproductive Hospital Affiliated to Shandong University
Shandong, China
Reproductive & Genetic hospital of CITIC-XIANGYA
Xiangya, China
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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