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

NCT04249297 | Unknown

• 1 other identifier: DYDR5005
• Study Type: observational
• Target: 1,150
• Locations: 2 countries
• Sites: 52

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.

Conditions

Infertility

Keywords

dydrogesterone; Duphaston; Assisted Reproductive Technology; In-Vitro Fertilization; luteal phase support

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Patient's convenience and global satisfaction

  2 weeks, 10 weeks

• The overall pregnancy rate

  10 weeks

• The rate of positive biochemical pregnancy test

  2 weeks

Study Arms (1)

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)

Interventions

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).

IVF/Dydrogesteron

Eligibility Criteria

• Age: 18 Years - 99 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott: lead

Study Sites (52)

LLP Institute of Reproductive Medicine

Almaty, 050008, Kazakhstan

RECRUITING

PERSONA International Clinical Center for Reproductology

Almaty, 050060, Kazakhstan

RECRUITING

Regional Clinical Perinatal Center "Dar"

Barnaul, 656045, Russia

COMPLETED

Clinic of Family Medicine

Chelyabinsk, 454021, Russia

COMPLETED

Regional Perinatal Center

Chelyabinsk, 454080, Russia

COMPLETED

ART Department Irkutsk Regional Clinical Hospital

Irkutsk, 664003, Russia

COMPLETED

Mother and Child

Irkutsk, 664005, Russia

COMPLETED

Ivanovo Research Institute motherhood and childhood named after VN Gorodkov

Ivanovo, 153045, Russia

COMPLETED

Mother and Child

Kazan', 117335, Russia

COMPLETED

Scandinavia

Kazan', 420111, Russia

COMPLETED

Clinic for male and female health 'OXY-center'

Krasnodar, 350020, Russia

COMPLETED

Clinic of Kuban State Medical University

Krasnodar, 350072, Russia

COMPLETED

Regional Center for Family Health and Reproduction

Krasnodar, 350901, Russia

COMPLETED

Mother and Child

Krasnoyarsk, 660037, Russia

COMPLETED

IVF Center

Lipetsk, 398007, Russia

COMPLETED

Reproductive Health Clinic 'Biootpima'

Moscow, 105043, Russia

COMPLETED

Generation NEXT

Moscow, 109544, Russia

COMPLETED

Medical Center Altra Vita

Moscow, 117186, Russia

COMPLETED

Kulakov National Medical Research Center of Obstetrics, Gynecology and Perinatology

Moscow, 117198, Russia

COMPLETED

Family Planning and Reproduction Center

Moscow, 117209, Russia

COMPLETED

Mother and Child Perinatal Center

Moscow, 117209, Russia

COMPLETED

NOVA Clinic, Center for Reproduction and Genetics

Moscow, 119048, Russia

COMPLETED

Medical Center MIRA

Moscow, 119334, Russia

COMPLETED

Mother and Child Kuntsevo

Moscow, 121374, Russia

COMPLETED

Center of Reproduction 'Line of Life'

Moscow, 121471, Russia

COMPLETED

Mother and Child Savelovskaya

Moscow, 127015, Russia

COMPLETED

Clinic 'IVF Center'

Moscow, 129075, Russia

COMPLETED

Mother and Child Khodynka

Moscow, 129090, Russia

COMPLETED

Multidisciplinary Medical Center 'MAK IVF'

Moscow, 129110, Russia

COMPLETED

Mother and Child Lapino

Moscow, 143081, Russia

COMPLETED

Volga Regional Medical Center, Clinical Hospital #1

Nizhny Novgorod, 603000, Russia

COMPLETED

Clinical Hospital 'Avicenna'

Novosibirsk, 630007, Russia

COMPLETED

Novosibirsk Center for Reproductive Medicine 'Mother and Child'

Novosibirsk, 630037, Russia

COMPLETED

Reproduction Clinic ' Philosophy of Life'

Perm, 614107, Russia

COMPLETED

Center for Reproductive Technologies 'EmbryLife'

Saint Petersburg, 190031, Russia

COMPLETED

Ava-Peter Reproduction Clinic

Saint Petersburg, 191186, Russia

COMPLETED

Scandinavia Reproduction Clinic

Saint Petersburg, 196211, Russia

COMPLETED

Reproductive Medicine Clinic ICLINIC

Saint Petersburg, 197110, Russia

COMPLETED

Center for Reproductive Medicine

Saint Petersburg, 197371, Russia

COMPLETED

Ott Research Institute of Obstetrics, Gynecology and Reproductology

Saint Petersburg, 199034, Russia

COMPLETED

Mother and Child St. Petersburg

Saint Petersburg, 199106, Russia

COMPLETED

Mother and Child

Samara, 443072, Russia

COMPLETED

Regional Center for Reproductive Medicine Dynasty

Samara, 443095, Russia

COMPLETED

Saratov Regional Perinatal Center

Saratov, 640015, Russia

COMPLETED

Stavropol Regional Clinical Diagnostic Center, ART Department

Stavropol, 355029, Russia

COMPLETED

Center ART, Siberian State Medical University

Tomsk, 634050, Russia

COMPLETED

Mother and Child

Tyumen, 625062, Russia

COMPLETED

Volgograd State Medical University, Clinik #1

Volgograd, 400079, Russia

COMPLETED

Voronezh Regional Clinical Hospital #1, Perinatal Center

Voronezh, 394066, Russia

COMPLETED

Research Institute for the Protection of Maternity and Infancy

Yekaterinburg, 620028, Russia

COMPLETED

Clinical diagnostic center "Maternal and child health"

Yekaterinburg, 620041, Russia

COMPLETED

IVF Center Partus

Yekaterinburg, 620075, Russia

COMPLETED

MeSH Terms

Conditions

Infertility

Interventions

Dydrogesterone

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Tatiana A Nazarenko, Prof

  Kulakov National Medical Research Center of Obstetrics, Gynecology and Perinatology

  STUDY CHAIR

Central Study Contacts

Aleksander Akimov

CONTACT

74952584280; a.akimov@abbott.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2020
• First Posted: January 30, 2020
• Study Start: March 3, 2020
• Primary Completion: March 1, 2022
• Study Completion: December 1, 2022
• Last Updated: December 28, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

RU (50); KA (2)