Phase
Condition
Infertility
Treatment
N/AClinical Study ID
Ages 18-99 Female
Study Summary
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
Study Description
Connect with a study center
LLP Institute of Reproductive Medicine
Almaty, 050008
KazakhstanActive - Recruiting
PERSONA International Clinical Center for Reproductology
Almaty, 050060
KazakhstanActive - Recruiting
Regional Clinical Perinatal Center "Dar"
Barnaul, 656045
Russian FederationCompleted
Clinic of Family Medicine
Chelyabinsk, 454021
Russian FederationCompleted
Regional Perinatal Center
Chelyabinsk, 454080
Russian FederationCompleted
Clinical diagnostic center "Maternal and child health"
Ekaterinburg, 620041
Russian FederationCompleted
IVF Center Partus
Ekaterinburg, 620075
Russian FederationCompleted
Research Institute for the Protection of Maternity and Infancy
Ekaterinburg, 620028
Russian FederationCompleted
ART Department Irkutsk Regional Clinical Hospital
Irkutsk, 664003
Russian FederationCompleted
Mother and Child
Irkutsk, 664005
Russian FederationCompleted
Ivanovo Research Institute motherhood and childhood named after VN Gorodkov
Ivanovo, 153045
Russian FederationCompleted
Mother and Child
Kazan, 117335
Russian FederationCompleted
Scandinavia
Kazan, 420111
Russian FederationCompleted
Clinic for male and female health 'OXY-center'
Krasnodar, 350020
Russian FederationCompleted
Clinic of Kuban State Medical University
Krasnodar, 350072
Russian FederationCompleted
Regional Center for Family Health and Reproduction
Krasnodar, 350901
Russian FederationCompleted
Mother and Child
Krasnoyarsk, 660037
Russian FederationCompleted
IVF Center
Lipetsk, 398007
Russian FederationCompleted
Center of Reproduction 'Line of Life'
Moscow, 121471
Russian FederationCompleted
Clinic 'IVF Center'
Moscow, 129075
Russian FederationCompleted
Family Planning and Reproduction Center
Moscow, 117209
Russian FederationCompleted
Generation NEXT
Moscow, 109544
Russian FederationCompleted
Kulakov National Medical Research Center of Obstetrics, Gynecology and Perinatology
Moscow, 117198
Russian FederationCompleted
Medical Center Altra Vita
Moscow, 117186
Russian FederationCompleted
Medical Center MIRA
Moscow, 119334
Russian FederationCompleted
Mother and Child Khodynka
Moscow, 129090
Russian FederationCompleted
Mother and Child Kuntsevo
Moscow, 121374
Russian FederationCompleted
Mother and Child Lapino
Moscow, 143081
Russian FederationCompleted
Mother and Child Perinatal Center
Moscow, 117209
Russian FederationCompleted
Mother and Child Savelovskaya
Moscow, 127015
Russian FederationCompleted
Multidisciplinary Medical Center 'MAK IVF'
Moscow, 129110
Russian FederationCompleted
NOVA Clinic, Center for Reproduction and Genetics
Moscow, 119048
Russian FederationCompleted
Reproductive Health Clinic 'Biootpima'
Moscow, 105043
Russian FederationCompleted
Volga Regional Medical Center, Clinical Hospital #1
Nizhny Novgorod, 603000
Russian FederationCompleted
Clinical Hospital 'Avicenna'
Novosibirsk, 630007
Russian FederationCompleted
Novosibirsk Center for Reproductive Medicine 'Mother and Child'
Novosibirsk, 630037
Russian FederationCompleted
Reproduction Clinic ' Philosophy of Life'
Perm, 614107
Russian FederationCompleted
Ava-Peter Reproduction Clinic
Saint Petersburg, 191186
Russian FederationCompleted
Center for Reproductive Medicine
Saint Petersburg, 197371
Russian FederationCompleted
Center for Reproductive Technologies 'EmbryLife'
Saint Petersburg, 190031
Russian FederationCompleted
Mother and Child St. Petersburg
Saint Petersburg, 199106
Russian FederationCompleted
Ott Research Institute of Obstetrics, Gynecology and Reproductology
Saint Petersburg, 199034
Russian FederationCompleted
Reproductive Medicine Clinic ICLINIC
Saint Petersburg, 197110
Russian FederationCompleted
Scandinavia Reproduction Clinic
Saint Petersburg, 196211
Russian FederationCompleted
Mother and Child
Samara, 443072
Russian FederationCompleted
Regional Center for Reproductive Medicine Dynasty
Samara, 443095
Russian FederationCompleted
Saratov Regional Perinatal Center
Saratov, 640015
Russian FederationCompleted
Stavropol Regional Clinical Diagnostic Center, ART Department
Stavropol', 355029
Russian FederationCompleted
Center ART, Siberian State Medical University
Tomsk, 634050
Russian FederationCompleted
Mother and Child
Tyumen, 625062
Russian FederationCompleted
Volgograd State Medical University, Clinik #1
Volgograd, 400079
Russian FederationCompleted
Voronezh Regional Clinical Hospital #1, Perinatal Center
Voronezh, 394066
Russian FederationCompleted
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