Predictors of Pregnancy Rate in Assisted Reproductive Technology According to Actual Guidelines

Last updated: December 22, 2021
Sponsor: Abbott
Overall Status: Active - Recruiting

Phase

N/A

Condition

Infertility

Treatment

N/A

Clinical Study ID

NCT04249297
DYDR5005
  • Ages 18-99
  • Female

Study Summary

Goals: To explore the association of probability of pregnancy with certain prognostic factors in patients undergoing assisted reproductive technology in Russian population according to international and national guidelines.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Female, age ≥ 18 years
  • Prescribed Duphaston® according local marketing authorization and international andRussian In Vitro Fertilisation guidelines for luteal phase support as part of anAssisted Reproductive Technologies (1 tablet 3 times a day starting at the day ofoocyte retrieval)
  • Elective single embryo transfer in fresh cycle
  • Normal ultrasound at enrollment without evidence of clinically significant abnormalityconsistent with finding adequate for Assisted Reproductive Technologies with respectto uterus and adnexa (incl. no hydrosalpinx or clinically relevant uterine fibroids)
  • Signed the Patient Authorization for Use/Disclosure of Data

Exclusion

Exclusion Criteria:

  • Evidence of cardiovascular, respiratory, urogenital, gastrointestinal/hepatic,hematologic/immunologic, HEENT (head, ears, eyes, nose, throat),dermatologic/connective tissue, musculoskeletal, metabolic/nutritional, endocrine,neurologic/psychiatric, allergy, recent major surgery (< 3 months), or other relevantdiseases as revealed by history, physical examination and/or laboratory assessmentswhich could limit participation in or completion of the study
  • Acute urogenital disease
  • Known allergic reactions to dydrogesterone or other progestogens products
  • Any contraindication or other condition that precludes use of dydrogesterone in aparticular patient, in accordance with the precautions listed in the locally approvedlabel (Instructions for the medical use of Duphaston®):
  • Hypersensitivity to dydrogesterone or any of the excipients
  • Diagnosed or suspected progestogen-dependent neoplasms (e.g., meningioma)
  • Undiagnosed vaginal bleeding
  • Hepatic impairment associated with acute or chronic, current or past liver diseases (as long as liver function tests have failed to return to normal)
  • Presence or history of malignant liver tumors
  • Galactose intolerance, lactase deficiency, glucose-galactose malabsorption syndrome
  • Breastfeeding.
  • Presence or history of porphyria
  • Age below 18 years, since safety and efficacy in adolescents aged below 18 years havenot been established
  • Spontaneous abortion (miscarriage) or missed abortion in luteal-phase support as partof assisted reproductive technology
  • Participation in any other clinical trial within 30 days prior to program start
  • Mental disability or any other lack of fitness, in the Investigator's opinion, topreclude subjects in or to complete the study
  • Current or recent substance abuse, including alcohol and tobacco (Note: Patients whostopped tobacco usage at least 3 months prior to screening visit would be allowed)
  • History of prior chemotherapy
  • Usage of other progestogens except dydrogesterone
  • Contraindication for pregnancy
  • Refusal or inability to comply with the conditions of this program for any reason,including scheduled clinic visits and laboratory tests.
  • Gestational surrogacy, oocyte or embryo donation

Study Design

Total Participants: 1150
Study Start date:
March 03, 2020
Estimated Completion Date:
December 31, 2022

Study Description

Research on significant factors (predictors) of pregnancy rate in In Vitro Fertilization (IVF) and Intracytoplasmatic Sperm Injection (ICSI) cycles in Russian population according to actual national and international guidelines in patients using oral dydrogesterone for luteal phase support in assisted reproductive technology. Investigating the strength of the relationship and assessing coefficients of impact on the pregnancy rate.

Creating a predictive table of Clinical Pregnancy in IVF and ICSI cycles and 4-5 most impact predictors.

Connect with a study center

  • LLP Institute of Reproductive Medicine

    Almaty, 050008
    Kazakhstan

    Active - Recruiting

  • PERSONA International Clinical Center for Reproductology

    Almaty, 050060
    Kazakhstan

    Active - Recruiting

  • Regional Clinical Perinatal Center "Dar"

    Barnaul, 656045
    Russian Federation

    Completed

  • Clinic of Family Medicine

    Chelyabinsk, 454021
    Russian Federation

    Completed

  • Regional Perinatal Center

    Chelyabinsk, 454080
    Russian Federation

    Completed

  • Clinical diagnostic center "Maternal and child health"

    Ekaterinburg, 620041
    Russian Federation

    Completed

  • IVF Center Partus

    Ekaterinburg, 620075
    Russian Federation

    Completed

  • Research Institute for the Protection of Maternity and Infancy

    Ekaterinburg, 620028
    Russian Federation

    Completed

  • ART Department Irkutsk Regional Clinical Hospital

    Irkutsk, 664003
    Russian Federation

    Completed

  • Mother and Child

    Irkutsk, 664005
    Russian Federation

    Completed

  • Ivanovo Research Institute motherhood and childhood named after VN Gorodkov

    Ivanovo, 153045
    Russian Federation

    Completed

  • Mother and Child

    Kazan, 117335
    Russian Federation

    Completed

  • Scandinavia

    Kazan, 420111
    Russian Federation

    Completed

  • Clinic for male and female health 'OXY-center'

    Krasnodar, 350020
    Russian Federation

    Completed

  • Clinic of Kuban State Medical University

    Krasnodar, 350072
    Russian Federation

    Completed

  • Regional Center for Family Health and Reproduction

    Krasnodar, 350901
    Russian Federation

    Completed

  • Mother and Child

    Krasnoyarsk, 660037
    Russian Federation

    Completed

  • IVF Center

    Lipetsk, 398007
    Russian Federation

    Completed

  • Center of Reproduction 'Line of Life'

    Moscow, 121471
    Russian Federation

    Completed

  • Clinic 'IVF Center'

    Moscow, 129075
    Russian Federation

    Completed

  • Family Planning and Reproduction Center

    Moscow, 117209
    Russian Federation

    Completed

  • Generation NEXT

    Moscow, 109544
    Russian Federation

    Completed

  • Kulakov National Medical Research Center of Obstetrics, Gynecology and Perinatology

    Moscow, 117198
    Russian Federation

    Completed

  • Medical Center Altra Vita

    Moscow, 117186
    Russian Federation

    Completed

  • Medical Center MIRA

    Moscow, 119334
    Russian Federation

    Completed

  • Mother and Child Khodynka

    Moscow, 129090
    Russian Federation

    Completed

  • Mother and Child Kuntsevo

    Moscow, 121374
    Russian Federation

    Completed

  • Mother and Child Lapino

    Moscow, 143081
    Russian Federation

    Completed

  • Mother and Child Perinatal Center

    Moscow, 117209
    Russian Federation

    Completed

  • Mother and Child Savelovskaya

    Moscow, 127015
    Russian Federation

    Completed

  • Multidisciplinary Medical Center 'MAK IVF'

    Moscow, 129110
    Russian Federation

    Completed

  • NOVA Clinic, Center for Reproduction and Genetics

    Moscow, 119048
    Russian Federation

    Completed

  • Reproductive Health Clinic 'Biootpima'

    Moscow, 105043
    Russian Federation

    Completed

  • Volga Regional Medical Center, Clinical Hospital #1

    Nizhny Novgorod, 603000
    Russian Federation

    Completed

  • Clinical Hospital 'Avicenna'

    Novosibirsk, 630007
    Russian Federation

    Completed

  • Novosibirsk Center for Reproductive Medicine 'Mother and Child'

    Novosibirsk, 630037
    Russian Federation

    Completed

  • Reproduction Clinic ' Philosophy of Life'

    Perm, 614107
    Russian Federation

    Completed

  • Ava-Peter Reproduction Clinic

    Saint Petersburg, 191186
    Russian Federation

    Completed

  • Center for Reproductive Medicine

    Saint Petersburg, 197371
    Russian Federation

    Completed

  • Center for Reproductive Technologies 'EmbryLife'

    Saint Petersburg, 190031
    Russian Federation

    Completed

  • Mother and Child St. Petersburg

    Saint Petersburg, 199106
    Russian Federation

    Completed

  • Ott Research Institute of Obstetrics, Gynecology and Reproductology

    Saint Petersburg, 199034
    Russian Federation

    Completed

  • Reproductive Medicine Clinic ICLINIC

    Saint Petersburg, 197110
    Russian Federation

    Completed

  • Scandinavia Reproduction Clinic

    Saint Petersburg, 196211
    Russian Federation

    Completed

  • Mother and Child

    Samara, 443072
    Russian Federation

    Completed

  • Regional Center for Reproductive Medicine Dynasty

    Samara, 443095
    Russian Federation

    Completed

  • Saratov Regional Perinatal Center

    Saratov, 640015
    Russian Federation

    Completed

  • Stavropol Regional Clinical Diagnostic Center, ART Department

    Stavropol', 355029
    Russian Federation

    Completed

  • Center ART, Siberian State Medical University

    Tomsk, 634050
    Russian Federation

    Completed

  • Mother and Child

    Tyumen, 625062
    Russian Federation

    Completed

  • Volgograd State Medical University, Clinik #1

    Volgograd, 400079
    Russian Federation

    Completed

  • Voronezh Regional Clinical Hospital #1, Perinatal Center

    Voronezh, 394066
    Russian Federation

    Completed

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