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

Infertility Clinical Trial

— IRIS  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04249297
• Other study ID #: DYDR5005
• Status: Recruiting
• Start date: March 3, 2020
• Est. completion date: December 2022

Study information

• Verified date: December 2021
• Source: Abbott
• Contact: Aleksander Akimov
• Phone: 74952584280
• Email: a.akimov[@]abbott.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1150
• Est. completion date: December 2022
• Est. primary completion date: March 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility

Intervention

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).

Locations

Country	Name	City	State
Kazakhstan	LLP Institute of Reproductive Medicine	Almaty
Kazakhstan	PERSONA International Clinical Center for Reproductology	Almaty
Russian Federation	Regional Clinical Perinatal Center "Dar"	Barnaul
Russian Federation	Clinic of Family Medicine	Chelyabinsk
Russian Federation	Regional Perinatal Center	Chelyabinsk
Russian Federation	Clinical diagnostic center "Maternal and child health"	Ekaterinburg
Russian Federation	IVF Center Partus	Ekaterinburg
Russian Federation	Research Institute for the Protection of Maternity and Infancy	Ekaterinburg
Russian Federation	ART Department Irkutsk Regional Clinical Hospital	Irkutsk
Russian Federation	Mother and Child	Irkutsk
Russian Federation	Ivanovo Research Institute motherhood and childhood named after VN Gorodkov	Ivanovo
Russian Federation	Mother and Child	Kazan
Russian Federation	Scandinavia	Kazan
Russian Federation	Clinic for male and female health 'OXY-center'	Krasnodar
Russian Federation	Clinic of Kuban State Medical University	Krasnodar
Russian Federation	Regional Center for Family Health and Reproduction	Krasnodar
Russian Federation	Mother and Child	Krasnoyarsk
Russian Federation	IVF Center	Lipetsk
Russian Federation	Center of Reproduction 'Line of Life'	Moscow
Russian Federation	Clinic 'IVF Center'	Moscow
Russian Federation	Family Planning and Reproduction Center	Moscow
Russian Federation	Generation NEXT	Moscow
Russian Federation	Kulakov National Medical Research Center of Obstetrics, Gynecology and Perinatology	Moscow
Russian Federation	Medical Center Altra Vita	Moscow
Russian Federation	Medical Center MIRA	Moscow
Russian Federation	Mother and Child Khodynka	Moscow
Russian Federation	Mother and Child Kuntsevo	Moscow
Russian Federation	Mother and Child Lapino	Moscow
Russian Federation	Mother and Child Perinatal Center	Moscow
Russian Federation	Mother and Child Savelovskaya	Moscow
Russian Federation	Multidisciplinary Medical Center 'MAK IVF'	Moscow
Russian Federation	NOVA Clinic, Center for Reproduction and Genetics	Moscow
Russian Federation	Reproductive Health Clinic 'Biootpima'	Moscow
Russian Federation	Volga Regional Medical Center, Clinical Hospital #1	Nizhny Novgorod
Russian Federation	Clinical Hospital 'Avicenna'	Novosibirsk
Russian Federation	Novosibirsk Center for Reproductive Medicine 'Mother and Child'	Novosibirsk
Russian Federation	Reproduction Clinic ' Philosophy of Life'	Perm
Russian Federation	Ava-Peter Reproduction Clinic	Saint Petersburg
Russian Federation	Center for Reproductive Medicine	Saint Petersburg
Russian Federation	Center for Reproductive Technologies 'EmbryLife'	Saint Petersburg
Russian Federation	Mother and Child St. Petersburg	Saint Petersburg
Russian Federation	Ott Research Institute of Obstetrics, Gynecology and Reproductology	Saint Petersburg
Russian Federation	Reproductive Medicine Clinic ICLINIC	Saint Petersburg
Russian Federation	Scandinavia Reproduction Clinic	Saint Petersburg
Russian Federation	Mother and Child	Samara
Russian Federation	Regional Center for Reproductive Medicine Dynasty	Samara
Russian Federation	Saratov Regional Perinatal Center	Saratov
Russian Federation	Stavropol Regional Clinical Diagnostic Center, ART Department	Stavropol'
Russian Federation	Center ART, Siberian State Medical University	Tomsk
Russian Federation	Mother and Child	Tyumen
Russian Federation	Volgograd State Medical University, Clinik #1	Volgograd
Russian Federation	Voronezh Regional Clinical Hospital #1, Perinatal Center	Voronezh

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Countries where clinical trial is conducted

Kazakhstan,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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