Safety and Efficacy Study in in Vitro Fertilisation (IVF) Patients

IBSA

Status and phase

Completed

Phase 3

Conditions

Infertility

Treatments

Drug: Menotropins

Study type

Interventional

Funder types

Industry

Identifiers

NCT01312766

2010-021021-13 (EudraCT Number)

10EU/hMG02

Details and patient eligibility

About

The purpose of the non-inferiority study is to evaluate the clinical efficacy and the safety of two different subcutaneous hMG preparations when administered to patients undergoing controlled ovarian stimulation for IVF.

Enrollment

270 patients

Sex

Female

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Women undergoing ovarian stimulation for IVF with the following characteristics:
- Able and willing to sign the Patient Consent Form and adhere to the study visitation schedule
- >18 and <40 years old
- BMI between 18 and 30 kg/m2
- less than 3 previously completed IVF cycles (i.e. completed cycle = egg recovery)
- basal FSH <10 IU/L and E2 <80 pg/ml (~290 pmol/l)
- Within 12 months of the beginning of the study, uterine cavity consistent with expected normal function as assessed through transvaginal ultrasound, hysterosalpingogram, sonohysterogram or hysteroscopic examination
- Successful down-regulation performed with a standard GnRH-Agonist long protocol (Criteria for successful down-regulation: endometrial thickness < 7mm or serum E2 level <50 pg/ml (~185 pmol/l).

Exclusion criteria

age <18 and >40 years
primary ovarian failure or women known as poor responders (i.e. requiring more than 225 IU of hMG as a starting dose in previous treatment cycles or having less than 3 oocytes retrieved, or with a pre-ovulatory E2 serum concentration <500pg/ml (~1800 pmol/l))
PCOS
one or both ovaries inaccessible for oocyte retrieval
ovarian cysts >10 mm
hydrosalpinx that have not been surgically removed or ligated;
stage 3 or 4 endometriosis
oocyte donation
implantation of previously frozen embryos
patients affected by pathologies associated with any contraindication of being pregnant
hypersensitivity to the study medication
abnormal bleeding of undetermined origin
uncontrolled thyroid or adrenal dysfunction
neoplasias
severe impairment of renal and/or hepatic function
use of concomitant medications that might interfere with study evaluations (e.g. non-study hormonal medications, prostaglandin inhibitors, psychotropic agents)