InfertilityIRISNCT04249297
Predictors of Pregnancy Rate in Assisted Reproductive Technology According to Actual Guidelines
An observational study of Infertility, run by Abbott at 52 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Duphaston® (Dydrogesteron)
- Type of treatment
- Pill or oral medicine
- How many people
- 1,150 participants
- Where
- 52 sitesin 2 countries
- Study dates
- 3 Mar 2020to Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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)
Show all 22Show fewer
- 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
Trial locations and contacts
52 sites in 2 countries.
52 sites in 2 countries
Russia50 sites
- Completed
Regional Clinical Perinatal Center "Dar"
Barnaul, 656045
- Completed
Clinic of Family Medicine
Chelyabinsk, 454021
- Completed
Regional Perinatal Center
Chelyabinsk, 454080
- Completed
ART Department Irkutsk Regional Clinical Hospital
Irkutsk, 664003
- Completed
Mother and Child
Irkutsk, 664005
- Completed
Ivanovo Research Institute motherhood and childhood named after VN Gorodkov
Ivanovo, 153045
- Completed
Mother and Child
Kazan', 117335
- Completed
Scandinavia
Kazan', 420111
- Completed
Clinic for male and female health 'OXY-center'
Krasnodar, 350020
- Completed
Clinic of Kuban State Medical University
Krasnodar, 350072
- Completed
Regional Center for Family Health and Reproduction
Krasnodar, 350901
- Completed
Mother and Child
Krasnoyarsk, 660037
- Completed
IVF Center
Lipetsk, 398007
- Completed
Reproductive Health Clinic 'Biootpima'
Moscow, 105043
- Completed
Generation NEXT
Moscow, 109544
- Completed
Medical Center Altra Vita
Moscow, 117186
- Completed
Kulakov National Medical Research Center of Obstetrics, Gynecology and Perinatology
Moscow, 117198
- Completed
Family Planning and Reproduction Center
Moscow, 117209
- Completed
Mother and Child Perinatal Center
Moscow, 117209
- Completed
NOVA Clinic, Center for Reproduction and Genetics
Moscow, 119048
- Completed
Medical Center MIRA
Moscow, 119334
- Completed
Mother and Child Kuntsevo
Moscow, 121374
- Completed
Center of Reproduction 'Line of Life'
Moscow, 121471
- Completed
Mother and Child Savelovskaya
Moscow, 127015
- Completed
Clinic 'IVF Center'
Moscow, 129075
- Completed
Mother and Child Khodynka
Moscow, 129090
- Completed
Multidisciplinary Medical Center 'MAK IVF'
Moscow, 129110
- Completed
Mother and Child Lapino
Moscow, 143081
- Completed
Volga Regional Medical Center, Clinical Hospital #1
Nizhny Novgorod, 603000
- Completed
Clinical Hospital 'Avicenna'
Novosibirsk, 630007
- Completed
Novosibirsk Center for Reproductive Medicine 'Mother and Child'
Novosibirsk, 630037
- Completed
Reproduction Clinic ' Philosophy of Life'
Perm, 614107
- Completed
Center for Reproductive Technologies 'EmbryLife'
Saint Petersburg, 190031
- Completed
Ava-Peter Reproduction Clinic
Saint Petersburg, 191186
- Completed
Scandinavia Reproduction Clinic
Saint Petersburg, 196211
- Completed
Reproductive Medicine Clinic ICLINIC
Saint Petersburg, 197110
- Completed
Center for Reproductive Medicine
Saint Petersburg, 197371
- Completed
Ott Research Institute of Obstetrics, Gynecology and Reproductology
Saint Petersburg, 199034
- Completed
Mother and Child St. Petersburg
Saint Petersburg, 199106
- Completed
Mother and Child
Samara, 443072
- Completed
Regional Center for Reproductive Medicine Dynasty
Samara, 443095
- Completed
Saratov Regional Perinatal Center
Saratov, 640015
- Completed
Stavropol Regional Clinical Diagnostic Center, ART Department
Stavropol, 355029
- Completed
Center ART, Siberian State Medical University
Tomsk, 634050
- Completed
Mother and Child
Tyumen, 625062
- Completed
Volgograd State Medical University, Clinik #1
Volgograd, 400079
- Completed
Voronezh Regional Clinical Hospital #1, Perinatal Center
Voronezh, 394066
- Completed
Research Institute for the Protection of Maternity and Infancy
Yekaterinburg, 620028
- Completed
Clinical diagnostic center "Maternal and child health"
Yekaterinburg, 620041
- Completed
IVF Center Partus
Yekaterinburg, 620075
Kazakhstan2 sites, 2 recruiting
- Recruiting
LLP Institute of Reproductive Medicine
Almaty, 050008
- Recruiting
PERSONA International Clinical Center for Reproductology
Almaty, 050060
About this study
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)
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.
Read the 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.
- Conditions
- Infertility
- Being tested
- Duphaston® (Dydrogesteron)
- Keywords
- dydrogesterone, Duphaston, Assisted Reproductive Technology, In-Vitro Fertilization, luteal phase support
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Duphaston® (Dydrogesteron) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- female age (years),
- female height (cm) / weight (kg) / Body Mass Index (kg/m2),
- Antral Follicle Count,
- Ovarian Sensitivity Index,
- number of top-quality embryos,
- pre-implantation genetic testing (performed / not performed),
- day of embryo transfer,
- treatment history (number of previous attempts),
- infertility cause (male factor infertility, endometriosis, endometrial factor, myoma, tubal factor, idiopathic),
- endometrial thickness,
- serum Anti-Mullerian hormone level,
- year, season,
- race (Caucasian, Asian, Black) as predictors.
Measured: 10 weeks
Secondary outcomes (3)
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.
Measured: 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
Measured: 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).
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2020
- Study start3 Mar 2020
- Primary completionMar 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tatiana A Nazarenko, Prof, Study chair, Kulakov National Medical Research Center of Obstetrics, Gynecology and Perinatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04249297
- Sponsor's protocol ID
- DYDR5005
- Acronym
- IRIS
- Status last verified
- Dec 2021
- First submitted
- 29 Jan 2020
- Last updated
- 28 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04249297
- Acronym / sponsor ID
- IRIS / DYDR5005
- Conditions
- Infertility
- Keywords
- dydrogesterone, Duphaston, Assisted Reproductive Technology, In-Vitro Fertilization, luteal phase support
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,150 participants (estimated)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- 3 Mar 2020 (actual)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 30 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IVF/Dydrogesteron | – | Drug: Duphaston® (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 |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Duphaston® (Dydrogesteron)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). | Drug | IVF/Dydrogesteron |
Primary outcome
4-5 predictors with highest impact on the probability of clinical pregnancy as evaluated by a logistic regression model
Time frame: 10 weeks
Evaluating coefficients of the relationship between pregnancy rate and following variables: * female age (years), * female height (cm) / weight (kg) / Body Mass Index (kg/m2), * Antral Follicle Count, * Ovarian Sensitivity Index, * number of top-quality embryos, * pre-implantation genetic testing (performed / not performed), * day of embryo transfer, * treatment history (number of previous attempts), * infertility cause (male factor infertility, endometriosis, endometrial factor, myoma, tubal factor, idiopathic), * endometrial thickness, * serum Anti-Mullerian hormone level, * year, season, * race (Caucasian, Asian, Black) as predictors.
3 secondary outcomes
Patient's convenience and global satisfaction
Time frame: 2 weeks, 10 weeks
The overall pregnancy rate
Time frame: 10 weeks
The rate of positive biochemical pregnancy test
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tatiana A Nazarenko, Prof study chair
Kulakov National Medical Research Center of Obstetrics, Gynecology and Perinatology
52 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, run by Abbott at 52 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 52 sites in Russia, Kazakhstan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aleksander Akimov (74952584280 ext. 57461, a.akimov@abbott.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
4-5 predictors with highest impact on the probability of clinical pregnancy as evaluated by a logistic regression model (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2021.