Subcutaneous Progesterone Versus Vaginal Progesterone Gel for Luteal Phase Support in Patients Undergoing 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

NCT00827983

07EU/Prg06

Details and patient eligibility

About

Prospective, open, randomised, parallel, multicentre, two arm trial comparing a new form of luteal support (S.C.) to an approved comparator (vaginal gel).

Enrollment

683 patients

Sex

Female

Ages

18 to 42 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age 18- 42 (upon starting COH);
BMI <30 kg/m2;
<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 polyp or protruding sub-mucosal fibroid);
At least 3 retrieved oocytes;
Patient has given written informed consent.

Exclusion criteria

Intramural uterine fibroids that distort the uterine cavity or polyps >1 cm;
Stage III or IV endometriosis (endometriomas);
Hydrosalpinx;
History of past poor response to COH resulting in canceling ART;
Use of thawed/donated oocytes;
Use of thawed/donated embryos;
Patients affected by pathologies associated with any contraindication of being pregnant;
Hypersensitivity to study medication;
Uncontrolled adrenal or thyroid dysfunction;
Undiagnosed vaginal bleeding;
History of arterial disease;
Patients with hepatic impairment;
Neoplasias (current) or history of neoplasia that may be responsive to progesterone;
High grade cervical dysplasia;
Active thrombophlebitis or thromboembolic disorders, or a history of hormone-associated thrombophlebitis or thromboembolic disorders;
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 another trial within the past 2 months;
Use of concomitant medications that might interfere with the study evaluation;
Pre-implantation genetic diagnosis/screening.