Clinical trial NCT04249297: Predictors of Pregnancy Rate in Assisted Reproductive Technology According to Actual Guidelines
Official title: Multicenter Open-Label Observational Program to Research on Predictors of Pregnancy Rate in Assisted Reproductive Technology in the Russian Population and Kazakhstan Population According to Actual International and National Guidelines (IRIS)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infertility
Keywords: dydrogesterone
Duphaston
Assisted Reproductive Technology
In-Vitro Fertilization
luteal phase support
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2020-01-30
Enrollment: 1150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

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

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 relevant diseases as revealed by history, physical examination and/or laboratory assessments which 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 a particular patient, in accordance with the precautions listed in the locally approved label (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 have not been established
* Spontaneous abortion (miscarriage) or missed abortion in luteal-phase support as part of 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, to preclude subjects in or to complete the study
* Current or recent substance abuse, including alcohol and tobacco (Note: Patients who stopped 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

Primary outcomes:
measure: 4-5 predictors with highest impact on the probability of clinical pregnancy as evaluated by a logistic regression model
timeFrame: 10 weeks
Secondary outcomes:
measure: Patient's convenience and global satisfaction
timeFrame: 2 weeks, 10 weeks
measure: The overall pregnancy rate
timeFrame: 10 weeks
measure: The rate of positive biochemical pregnancy test
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Almaty
country: Kazakhstan
facility: LLP Institute of Reproductive Medicine
city: Almaty
country: Kazakhstan
facility: PERSONA International Clinical Center for Reproductology
city: Barnaul
country: Russian Federation
facility: Regional Clinical Perinatal Center "Dar"
city: Chelyabinsk
country: Russian Federation
facility: Clinic of Family Medicine
city: Chelyabinsk
country: Russian Federation
facility: Regional Perinatal Center
city: Ekaterinburg
country: Russian Federation
facility: Research Institute for the Protection of Maternity and Infancy
city: Ekaterinburg
country: Russian Federation
facility: Clinical diagnostic center "Maternal and child health"
city: Ekaterinburg
country: Russian Federation
facility: IVF Center Partus
city: Irkutsk
country: Russian Federation
facility: ART Department Irkutsk Regional Clinical Hospital
city: Irkutsk
country: Russian Federation
facility: Mother and Child
city: Ivanovo
country: Russian Federation
facility: Ivanovo Research Institute motherhood and childhood named after VN Gorodkov
city: Kazan
country: Russian Federation
facility: Mother and Child
city: Kazan
country: Russian Federation
facility: Scandinavia
city: Krasnodar
country: Russian Federation
facility: Clinic for male and female health 'OXY-center'
city: Krasnodar
country: Russian Federation
facility: Clinic of Kuban State Medical University
city: Krasnodar
country: Russian Federation
facility: Regional Center for Family Health and Reproduction
city: Krasnoyarsk
country: Russian Federation
facility: Mother and Child
city: Lipetsk
country: Russian Federation
facility: IVF Center
city: Moscow
country: Russian Federation
facility: Reproductive Health Clinic 'Biootpima'
city: Moscow
country: Russian Federation
facility: Generation NEXT
city: Moscow
country: Russian Federation
facility: Medical Center Altra Vita
city: Moscow
country: Russian Federation
facility: Kulakov National Medical Research Center of Obstetrics, Gynecology and Perinatology
city: Moscow
country: Russian Federation
facility: Family Planning and Reproduction Center
city: Moscow
country: Russian Federation
facility: Mother and Child Perinatal Center
city: Moscow
country: Russian Federation
facility: NOVA Clinic, Center for Reproduction and Genetics
city: Moscow
country: Russian Federation
facility: Medical Center MIRA
city: Moscow
country: Russian Federation
facility: Mother and Child Kuntsevo
city: Moscow
country: Russian Federation
facility: Center of Reproduction 'Line of Life'
city: Moscow
country: Russian Federation
facility: Mother and Child Savelovskaya
city: Moscow
country: Russian Federation
facility: Clinic 'IVF Center'
city: Moscow
country: Russian Federation
facility: Mother and Child Khodynka
city: Moscow
country: Russian Federation
facility: Multidisciplinary Medical Center 'MAK IVF'
city: Moscow
country: Russian Federation
facility: Mother and Child Lapino
city: Nizhny Novgorod
country: Russian Federation
facility: Volga Regional Medical Center, Clinical Hospital #1
city: Novosibirsk
country: Russian Federation
facility: Clinical Hospital 'Avicenna'
city: Novosibirsk
country: Russian Federation
facility: Novosibirsk Center for Reproductive Medicine 'Mother and Child'
city: Perm
country: Russian Federation
facility: Reproduction Clinic ' Philosophy of Life'
city: Saint Petersburg
country: Russian Federation
facility: Center for Reproductive Technologies 'EmbryLife'
city: Saint Petersburg
country: Russian Federation
facility: Ava-Peter Reproduction Clinic
city: Saint Petersburg
country: Russian Federation
facility: Scandinavia Reproduction Clinic
city: Saint Petersburg
country: Russian Federation
facility: Reproductive Medicine Clinic ICLINIC
city: Saint Petersburg
country: Russian Federation
facility: Center for Reproductive Medicine
city: Saint Petersburg
country: Russian Federation
facility: Ott Research Institute of Obstetrics, Gynecology and Reproductology
city: Saint Petersburg
country: Russian Federation
facility: Mother and Child St. Petersburg
city: Samara
country: Russian Federation
facility: Mother and Child
city: Samara
country: Russian Federation
facility: Regional Center for Reproductive Medicine Dynasty
city: Saratov
country: Russian Federation
facility: Saratov Regional Perinatal Center
city: Stavropol'
country: Russian Federation
facility: Stavropol Regional Clinical Diagnostic Center, ART Department
city: Tomsk
country: Russian Federation
facility: Center ART, Siberian State Medical University
city: Tyumen
country: Russian Federation
facility: Mother and Child
city: Volgograd
country: Russian Federation
facility: Volgograd State Medical University, Clinik #1
city: Voronezh
country: Russian Federation
facility: Voronezh Regional Clinical Hospital #1, Perinatal Center
Study officials:
affiliation: Kulakov National Medical Research Center of Obstetrics, Gynecology and Perinatology
name: Tatiana A Nazarenko, Prof
role: STUDY_CHAIR
References: