Mode
Home
Research
Clinical Trials Drug Pipeline Weekly Digests
Reference
Conditions Medications
Community
Questions
Text Size
Log in / Sign up
N/A Completed N=5,484

An Observational Study of Follitropin Alpha Biosimilar: the Real-world Data

Reproductive Issues · Reproductive Disorder · Fertility Disorders · Fertility Issues
Source: ClinicalTrials.gov NCT04854707 ↗
Enrolled (actual)
5,484
Serious AEs
0.0%
Results posted
Oct 2021
Primary outcomePrimary: Number of Oocytes Retrieved — 8.6; 10.3; 10.5; 9.6 The total number of retrieved oocytes — p=<0.001

Summary

Aim to investigate the efficacy of follitropin alpha biosimilar therapy (Primapur®) in nonselected real-world population.

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Oocytes Retrieved		 8.6; 10.3; 10.5; 9.6; 9.5 <0.001 sig
PRIMARY
Percentage of Participants With Ongoing Clinical Pregnancy Per Embryo Transfer		 39.3; 37.6; 37.9; 35.9; 38.4 0.314
SECONDARY
Number of Mature Oocytes		 6.7; 7.7; 7.6; 6.7; 6.8 <0.001 sig
SECONDARY
Number of Fertilized Oocytes		 5.8; 7.2; 7.3; 5.7; 6.1 <0.001 sig
SECONDARY
Total Dose of Follitropin Alpha Biosimilar Protocol, IU		 1672; 1919; 1952; 1711; 1825 <0.001 sig

Eligibility Criteria

Inclusion Criteria

  • Women with established causes of infertility and indications for the use of ART methods, according to the Order of the Ministry of Health of the Russian Federation "On the use of assisted reproductive technologies, contraindications and limitations to their use" No. 107 n dated August 30, 2012.
  • Infertility due to female and/or male factor.
  • Presence of ovaries accessible for aspiration of follicles.
  • Anatomical and functional capability of uterus to bear pregnancy.

Exclusion Criteria

  • Women with established contraindications to the use of ART methods, according to the Order of the Ministry of Health of the Russian Federation "On the use of assisted reproductive technologies, contraindications and limitations to their use" No. 107 n dated August 30, 2012.
  • Presence of pregnancy
  • Hypersensitivity to follitropin alfa or excipients.
  • Ovarian cysts (not associated with polycystic ovarian syndrome), uterine hemorrhage of unclear etiology
  • Premature ovarian failure
  • Presence of clinically significant systemic disease
  • Presence of chronic cardiovascular, hepatic, renal or pulmonary disease
  • Neoplasia
  • Narcomania, alcoholism
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04854707). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

Back to search