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

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.

Study Overview

• Status: Recruiting
• Conditions: Infertility
• Intervention / Treatment: Drug: Duphaston® (Dydrogesteron)

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 Type: Observational
• Enrollment (Anticipated): 1150

Contacts and Locations

• Study Contact: Name: Aleksander Akimov; Phone Number: 57461 74952584280; Email: a.akimov@abbott.com

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Drug: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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: 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.	10 weeks

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Abbott
• Investigators: Study Chair: Tatiana A Nazarenko, Prof, Kulakov National Medical Research Center of Obstetrics, Gynecology and Perinatology

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2020
• Primary Completion (Anticipated): March 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: January 29, 2020
• First Submitted That Met QC Criteria: January 29, 2020
• First Posted (Actual): January 30, 2020

Study Record Updates

• Last Update Posted (Actual): December 28, 2021
• Last Update Submitted That Met QC Criteria: December 22, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Assisted Reproductive Technology; Duphaston; luteal phase support; dydrogesterone; In-Vitro Fertilization
• Additional Relevant MeSH Terms: Infertility; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progestins; Dydrogesterone
• Other Study ID Numbers: DYDR5005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No