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NCT04249297

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

Last Updated: 2021-12-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-03

Study Completion Date

2022-12-31

Brief Summary

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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

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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

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Infertility

Keywords

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Duphaston® (Dydrogesteron)

Intervention Type 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).

Interventions

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Duphaston® (Dydrogesteron)

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tatiana A Nazarenko, Prof

Role: STUDY_CHAIR

Kulakov National Medical Research Center of Obstetrics, Gynecology and Perinatology

Yekaterinburg, , Russia

Site Status COMPLETED

Countries

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Kazakhstan Russia

Central Contacts

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Aleksander Akimov

Role: CONTACT

Phone: 74952584280

Email: [email protected]

Other Identifiers

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DYDR5005

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

IVF/Dydrogesteron

Duphaston® (Dydrogesteron)

Interventions

Duphaston® (Dydrogesteron)

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Abbott

Responsible Party

Principal Investigators

Tatiana A Nazarenko, Prof

Locations

LLP Institute of Reproductive Medicine

PERSONA International Clinical Center for Reproductology

Regional Clinical Perinatal Center "Dar"

Clinic of Family Medicine

Regional Perinatal Center

ART Department Irkutsk Regional Clinical Hospital

Mother and Child

Ivanovo Research Institute motherhood and childhood named after VN Gorodkov

Mother and Child

Scandinavia

Clinic for male and female health 'OXY-center'

Clinic of Kuban State Medical University

Regional Center for Family Health and Reproduction

Mother and Child

IVF Center

Reproductive Health Clinic 'Biootpima'

Generation NEXT

Medical Center Altra Vita

Kulakov National Medical Research Center of Obstetrics, Gynecology and Perinatology

Family Planning and Reproduction Center

Mother and Child Perinatal Center

NOVA Clinic, Center for Reproduction and Genetics

Medical Center MIRA

Mother and Child Kuntsevo

Center of Reproduction 'Line of Life'

Mother and Child Savelovskaya

Clinic 'IVF Center'

Mother and Child Khodynka

Multidisciplinary Medical Center 'MAK IVF'

Mother and Child Lapino

Volga Regional Medical Center, Clinical Hospital #1

Clinical Hospital 'Avicenna'

Novosibirsk Center for Reproductive Medicine 'Mother and Child'

Reproduction Clinic ' Philosophy of Life'

Center for Reproductive Technologies 'EmbryLife'

Ava-Peter Reproduction Clinic

Scandinavia Reproduction Clinic

Reproductive Medicine Clinic ICLINIC

Center for Reproductive Medicine

Ott Research Institute of Obstetrics, Gynecology and Reproductology

Mother and Child St. Petersburg

Mother and Child

Regional Center for Reproductive Medicine Dynasty

Saratov Regional Perinatal Center

Stavropol Regional Clinical Diagnostic Center, ART Department

Center ART, Siberian State Medical University

Mother and Child

Volgograd State Medical University, Clinik #1

Voronezh Regional Clinical Hospital #1, Perinatal Center

Research Institute for the Protection of Maternity and Infancy

Clinical diagnostic center "Maternal and child health"

IVF Center Partus

Countries

Central Contacts

Aleksander Akimov

Other Identifiers

DYDR5005