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

Abbott

Status: Unknown

Conditions: Infertility

Treatments: Drug: Duphaston® (Dydrogesteron)

Study type: Observational

Funder types: Industry

Identifiers

NCT04249297

DYDR5005

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,150 estimated patients

Sex: Female

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

1,150 participants in 1 patient group

IVF/Dydrogesteron

Description:

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

Treatment:

Drug: Duphaston® (Dydrogesteron)