Subcutaneous Progesterone Versus Vaginal Progesterone Tablets for Luteal Phase Support in In Vitro Fertilization (IVF)

IBSA

Status and phase

Completed

Phase 3

Conditions

In Vitro Fertilization

Treatments

Drug: Progesterone

Study type

Interventional

Funder types

Industry

Identifiers

NCT00828191

07USA/Prg05

Details and patient eligibility

About

Prospective, open, randomized, parallel, multicenter, two-arm trial to evaluate the efficacy and tolerability of a new progesterone formulation to be used for luteal support in IVF (Progesterone-IBSA) administered subcutaneously at a daily dose of 25 mg versus Progesterone tablets administered intravaginally at 100 mg twice daily for a total dose of 200 mg.

Enrollment

800 patients

Sex

Female

Ages

18 to 42 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient has given written informed consent;
BMI < 30 kg/m2;
Age 18 - 42 (upon starting COH);
<3 prior ART cycles (IVF, ICSI and related procedures);
Baseline (day 2-3 of cycling) FSH <15 IU/L and E2 <80 pg/mL;
Normal uterine cavity as per recent hysterosalpingogram, sonohysterogram or hysteroscopic exam (i.e. no polyps or protruding submucosal fibroids);
Patients must have at least three retrieved oocytes.

Exclusion criteria

Intramural uterine fibroids that distort the uterine cavity or polyps >1 cm;
Stage III or IV endometriosis (no endometriomas);
Hydrosalpinges;
History of past poor response to COH resulting in canceling ART;
Use of thawed/donated oocytes;
Use of thawed/donated embryos;
Gestational carrier;
Patients affected by pathologies associated with any contraindication of being pregnant;
Hypersensitivity to study medication;
Uncontrolled adrenal or thyroid dysfunction;
History of conditions (i.e. toxic shock syndrome) that would contraindicate use of a vaginal progesterone product;
History of arterial disease;
Patients with hepatic impairment (liver function tests > 2x upper limits of normal);
Patients with dermatologic disease;
Patients with renal impairment (estimated creatinine clearance <60 mL/min/1.73 m2);
Neoplasias (current) or history of neoplasia that may be responsive to progesterone;
High grade cervical dysplasia;
History of recurrent pregnancy loss defined as 3 or more spontaneous miscarriages, wherein pregnancy developed to a minimum of a gestational sac on TVUS;
Participation in a concurrent clinical trial or in another trial within the past 2 months;
Use of concomitant medications that might interfere with the study evaluation;
Pre-implantation genetic diagnosis/screening