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

Merck KGaA (EMD Serono)

Status: Completed

Conditions: Infertility

Treatments: Drug: No Intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT02889380

MS200106-0004

Details and patient eligibility

About

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.

Enrollment: 3,000 patients

Sex: Female

Ages: Under 35 years old

Volunteers: No Healthy Volunteers

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

Trial design

3,000 participants in 1 patient group

Cetrotide

Description:

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.

Treatment:

Drug: No Intervention