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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IVF/Dydrogesteron | Females aged ≥ 18 years, underwent In-Vitro Fertilization with Elective single embryo transfer in fresh cycle, for whom were prescribed treatment with Duphaston® for luteal phase support as part of an Assisted Reproductive Technology |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Duphaston® (Dydrogesteron) | Drug | No intervention. Description of routine practice only. Prescribed Duphaston® according local marketing authorization and international and Russian In-Vitro Fertilization guidelines for luteal phase support as part of an Assisted Reproductive Technology (1 tablet 3 times a day starting at the day of oocyte retrieval). |
| Measure | Description | Time Frame |
|---|---|---|
| 4-5 predictors with highest impact on the probability of clinical pregnancy as evaluated by a logistic regression model | Evaluating coefficients of the relationship between pregnancy rate and following variables:
| 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Patient's convenience and global satisfaction | Patient's convenience and global satisfaction of using medication for luteal phase support assessed by Treatment Satisfaction Questionnaire for Medication (TSQM-9). TSQM-9 is a 9-item instrument consisting of 3 scales: effectiveness scale (3 questions), convenience scale (3 questions) and global satisfaction scale (3 questions). The scores were computed by adding items for each domain. The lowest possible score was subtracted from this composite score and divided by the greatest possible score minus the lowest possible score. This provided a transformed score between 0 and 1 that was then multiplied by 100. TSQM-9 domain scores range from 0 to 100 with higher scores representing higher satisfaction on that domain. |
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Inclusion Criteria:
Exclusion Criteria:
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Females aged ≥ 18 years, underwent In-Vitro Fertilization with Elective single embryo transfer in fresh cycle, for whom were prescribed treatment with Duphaston® for luteal phase support as part of an Assisted Reproductive Technology
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aleksander Akimov | Contact | 74952584280 | 57461 | a.akimov@abbott.com |
| Name | Affiliation | Role |
|---|---|---|
| Tatiana A Nazarenko, Prof | Kulakov National Medical Research Center of Obstetrics, Gynecology and Perinatology | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LLP Institute of Reproductive Medicine | Recruiting | Almaty | 050008 | Kazakhstan | ||
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|
| 2 weeks, 10 weeks |
| The overall pregnancy rate | The overall pregnancy rate with confirmed clinical pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs, including ectopic pregnancy | 10 weeks |
| The rate of positive biochemical pregnancy test | The rate of positive biochemical pregnancy test (diagnosed by the detection of human chorionic gonadotropin (hCG) in serum or urine on Day 12-14 after embryo transfer). | 2 weeks |
| PERSONA International Clinical Center for Reproductology |
| Recruiting |
| Almaty |
| 050060 |
| Kazakhstan |
| Regional Clinical Perinatal Center "Dar" | Completed | Barnaul | 656045 | Russia |
| Clinic of Family Medicine | Completed | Chelyabinsk | 454021 | Russia |
| Regional Perinatal Center | Completed | Chelyabinsk | 454080 | Russia |
| ART Department Irkutsk Regional Clinical Hospital | Completed | Irkutsk | 664003 | Russia |
| Mother and Child | Completed | Irkutsk | 664005 | Russia |
| Ivanovo Research Institute motherhood and childhood named after VN Gorodkov | Completed | Ivanovo | 153045 | Russia |
| Mother and Child | Completed | Kazan' | 117335 | Russia |
| Scandinavia | Completed | Kazan' | 420111 | Russia |
| Clinic for male and female health 'OXY-center' | Completed | Krasnodar | 350020 | Russia |
| Clinic of Kuban State Medical University | Completed | Krasnodar | 350072 | Russia |
| Regional Center for Family Health and Reproduction | Completed | Krasnodar | 350901 | Russia |
| Mother and Child | Completed | Krasnoyarsk | 660037 | Russia |
| IVF Center | Completed | Lipetsk | 398007 | Russia |
| Reproductive Health Clinic 'Biootpima' | Completed | Moscow | 105043 | Russia |
| Generation NEXT | Completed | Moscow | 109544 | Russia |
| Medical Center Altra Vita | Completed | Moscow | 117186 | Russia |
| Kulakov National Medical Research Center of Obstetrics, Gynecology and Perinatology | Completed | Moscow | 117198 | Russia |
| Family Planning and Reproduction Center | Completed | Moscow | 117209 | Russia |
| Mother and Child Perinatal Center | Completed | Moscow | 117209 | Russia |
| NOVA Clinic, Center for Reproduction and Genetics | Completed | Moscow | 119048 | Russia |
| Medical Center MIRA | Completed | Moscow | 119334 | Russia |
| Mother and Child Kuntsevo | Completed | Moscow | 121374 | Russia |
| Center of Reproduction 'Line of Life' | Completed | Moscow | 121471 | Russia |
| Mother and Child Savelovskaya | Completed | Moscow | 127015 | Russia |
| Clinic 'IVF Center' | Completed | Moscow | 129075 | Russia |
| Mother and Child Khodynka | Completed | Moscow | 129090 | Russia |
| Multidisciplinary Medical Center 'MAK IVF' | Completed | Moscow | 129110 | Russia |
| Mother and Child Lapino | Completed | Moscow | 143081 | Russia |
| Volga Regional Medical Center, Clinical Hospital #1 | Completed | Nizhny Novgorod | 603000 | Russia |
| Clinical Hospital 'Avicenna' | Completed | Novosibirsk | 630007 | Russia |
| Novosibirsk Center for Reproductive Medicine 'Mother and Child' | Completed | Novosibirsk | 630037 | Russia |
| Reproduction Clinic ' Philosophy of Life' | Completed | Perm | 614107 | Russia |
| Center for Reproductive Technologies 'EmbryLife' | Completed | Saint Petersburg | 190031 | Russia |
| Ava-Peter Reproduction Clinic | Completed | Saint Petersburg | 191186 | Russia |
| Scandinavia Reproduction Clinic | Completed | Saint Petersburg | 196211 | Russia |
| Reproductive Medicine Clinic ICLINIC | Completed | Saint Petersburg | 197110 | Russia |
| Center for Reproductive Medicine | Completed | Saint Petersburg | 197371 | Russia |
| Ott Research Institute of Obstetrics, Gynecology and Reproductology | Completed | Saint Petersburg | 199034 | Russia |
| Mother and Child St. Petersburg | Completed | Saint Petersburg | 199106 | Russia |
| Mother and Child | Completed | Samara | 443072 | Russia |
| Regional Center for Reproductive Medicine Dynasty | Completed | Samara | 443095 | Russia |
| Saratov Regional Perinatal Center | Completed | Saratov | 640015 | Russia |
| Stavropol Regional Clinical Diagnostic Center, ART Department | Completed | Stavropol | 355029 | Russia |
| Center ART, Siberian State Medical University | Completed | Tomsk | 634050 | Russia |
| Mother and Child | Completed | Tyumen | 625062 | Russia |
| Volgograd State Medical University, Clinik #1 | Completed | Volgograd | 400079 | Russia |
| Voronezh Regional Clinical Hospital #1, Perinatal Center | Completed | Voronezh | 394066 | Russia |
| Research Institute for the Protection of Maternity and Infancy | Completed | Yekaterinburg | 620028 | Russia |
| Clinical diagnostic center "Maternal and child health" | Completed | Yekaterinburg | 620041 | Russia |
| IVF Center Partus | Completed | Yekaterinburg | 620075 | Russia |
| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D004394 | Dydrogesterone |
| ID | Term |
|---|---|
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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