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

NCT ID: NCT02889380

Last Updated: 2019-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-08-29

Study Completion Date

2017-04-26

Brief Summary

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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

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Conditions

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Infertility

Keywords

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Infertility Cetrotide Assisted reproductive technology (ART)

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

No Intervention

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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
Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Merck KGaA, Darmstadt, Germany

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Responsible

Role: STUDY_DIRECTOR

Merck Serono Co., Ltd., China

Locations

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Peking University Third Hospital

Beijing, , China

Site Status

The Third Affiliated Hospital of Guangzhou Medical University

Guangzhou, , China

Site Status

Reproductive Hospital Affiliated to Shandong University

Shandong, , China

Site Status

Reproductive & Genetic hospital of CITIC-XIANGYA

Xiangya, , China

Site Status

Countries

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China

Other Identifiers

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MS200106-0004

Identifier Type: -

Identifier Source: org_study_id