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NCT Number: NCT02889380

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

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.

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

Up to 35 year

Sex eligibility

Female

Study type

Observational

Primary location

Peking University Third Hospital, Beijing, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. Implantation Rate

    Time frame: 5 months

    Implantation rate = (The number of gestational sacs observed divided by the number of embryos transferred)*100

  3. 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

  4. Incidence and Severity of Ovarian Hyperstimulation Syndrome (OHSS)

    Time frame: 5 months

  5. 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

  6. Early Miscarriage Rate

    Time frame: 5 months

    (Number of Early miscarriages/Number of clinical pregnancies)*100

  7. 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

  8. Type of Gonadoptropin

    Time frame: 5 months

  9. Brand of Gonadotropin

    Time frame: 5 months

  10. Total Dose of Gonadotropin

    Time frame: 5 months

  11. Duration of Gonadotropin Administration

    Time frame: 5 months

  12. Cetrotide Start Day

    Time frame: up to 5 months

  13. Leading Follicle Size on the Day of Starting Cetrotide

    Time frame: on the day of starting Cetrotide (up to 5 months)

  14. Serum Luteinizing Hormone (LH) Level on the Day of Starting Cetrotide

    Time frame: on the day of starting Cetrotide (up to 5 months)

  15. Serum Estradiol (E2) Level on the Day of Starting Cetrotide

    Time frame: on the day of starting Cetrotide (up to 5 months)

  16. Serum Luteinizing Hormone (LH), Level on the Day of Human Chorionic Gonadotropin (hCG) Triggering

    Time frame: 5 months

  17. Serum Estradiol (E2) Level on the Day of Human Chorionic Gonadotropin (hCG) Triggering

    Time frame: on the day of hCG triggering (up to 5 months)

  18. Progesterone Level on the Day of Human Chorionic Gonadotropin (hCG) Triggering

    Time frame: on the day of hCG triggering (up to 5 months)

  19. Number of Follicles With Size 14 milimeter (mm) or More on the Day of Human Chorionic Gonadotropin (hCG) Triggering

    Time frame: on the day of hCG triggering (up to 5 months)

  20. Endometrial Thickness on the Day of Human Chorionic Gonadotropin (hCG) Triggering

    Time frame: on the day of hCG triggering (up to 5 months)

  21. Serum Luteinizing Hormone (LH) Level on the Day of Observed Premature Luteinizing Hormone (LH) Rise

    Time frame: 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

  22. Serum Estradiol (E2) Level on the Day of Observed Premature Luteinizing Hormone (LH) Rise

    Time frame: 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

  23. Serum Progesterone Level on the Day of Observed Premature Luteinizing Hormone (LH) Rise

    Time frame: 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

  24. Number of Follicles With Size 14 mm or More on the Day of Observed Premature Luteinizing Hormone (LH) Rise

    Time frame: 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

  25. Endometrial Thickness on the Day of Observed Premature Luteinizing Hormone (LH) Rise

    Time frame: 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

  26. Serum Progesterone Level on the Day of Observed Premature Progesterone Rise

    Time frame: 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

  27. Number of Oocytes Obtained

    Time frame: 5 months

  28. Number of Mature Metaphase II Oocytes Obtained

    Time frame: 5 months

  29. Fertilization Rate

    Time frame: 5 months

  30. Total Number of Embryos on Day 3/Blastocysts on Day 5

    Time frame: Day 3 and Day 5

  31. Number of Cryopreservation Embryos/Blastocysts on Day 3 or Day 5

    Time frame: Day 3, Day 5

  32. Number of Embryos/Blastocysts Transferred on Day 3 or Day 5

    Time frame: Day 3, Day 5

  33. Number of Good Quality Embryos/Blastocysts Transferred

    Time frame: up to 5 months

  34. Age

    Time frame: Baseline

  35. Duration of Infertility

    Time frame: Baseline

  36. Type of Infertility

    Time frame: Baseline

  37. Body Mass Index (BMI)

    Time frame: Baseline

  38. Smoking Status

    Time frame: Baseline

  39. Cause of Infertility

    Time frame: Baseline

Sponsors and collaborators

Lead sponsor

Merck KGaA, Darmstadt, Germany

Industry

Registry information

Official study title

A Retrospective Study in Chinese Good Prognosis Patients Undergoing ART Treatment to Investigate the Factors Associated With the Pregnancy Outcome of GnRH Antagonist IVF/ICSI Cycles

Acronym: FASSION

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 5, 2016
Registry last updated
Dec 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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