Immunogenicity of Repeated Follicle Stimulating Hormone (FSH) Stimulation Cycles

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IBSA

Status and phase

Completed
Phase 3

Conditions

Oocyte Donation

Treatments

Drug: FSH (Follicle Stimulating Hormone)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01785095
11E/FSH03

Details and patient eligibility

About

The purpose of the study is to evaluate immunogenic potential of FSH-IBSA in healthy volunteers undergoing controlled ovarian hyperstimulation (COH) in an oocyte donation program.

Enrollment

41 patients

Sex

Female

Ages

18 to 35 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Healthy female volunteers undergoing controlled ovarian hyperstimulation for oocyte donation with the following characteristics:
  • Able and willing to sign the Subject Consent Form and adhere to the study visit schedule;
  • >=18 and <35 years old;
  • Regular menstrual cycle (26 - 35 days);
  • BMI between 18 and 30 kg/m2;
  • First gonadotrophin treatment (i.e. naïve Subjects with regard to exposure to human derived or recombinant gonadotrophins);
  • basal FSH <10 IU/L and E2 <80 pg/ml (~290 pmol/l);
  • Normal TSH levels;
  • Willing to perform at least two consecutive oocyte retrieval cycles (with a wash out period of two months).

Exclusion criteria

  • Age <18 and >=35 years;
  • PCOS;
  • Endometriosis;
  • Subjects with evidences of autoimmune or rheumatic diseases;
  • Hypersensitivity to the active substance or to any of the excipients (lactose);
  • Abnormal bleeding of undetermined origin;
  • Subject found to be positive to anti-TSH antibodies (i.e. suffering from thyroidal diseases);
  • Uncontrolled adrenal dysfunction;
  • Neoplasia;
  • Severe impairment of renal and/or hepatic function;
  • Use of concomitant medications that might interfere with study evaluations (e.g. immunosuppressant, non-study hormonal medications, therapeutics proteins like insulin, growth hormone...).

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

41 participants in 1 patient group

FSH
Experimental group
Description:
FSH (Follicle stimulation hormone, 75 IU/vial) will be administered to women according to their need and response assessed by the Investigator.
Treatment:
Drug: FSH (Follicle Stimulating Hormone)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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