Status:
COMPLETED
Subcutaneous Progesterone Versus Vaginal Progesterone Tablets for Luteal Phase Support in In Vitro Fertilization (IVF)
Lead Sponsor:
IBSA Institut Biochimique SA
Conditions:
In Vitro Fertilization
Eligibility:
FEMALE
18-42 years
Phase:
PHASE3
Brief Summary
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)...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
800 Patients enrolled
Trial Details
Trial ID
NCT00828191
Start Date
December 1 2008
End Date
February 1 2012
Last Update
January 31 2013
Active Locations (8)
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1
Reproductive Partners Medical Group, Inc.
Redondo Beach, California, United States, 90277
2
Fertility Physicians of Northern California
San Jose, California, United States, 95124
3
Stanford University Medical Center
Stanford, California, United States, 94305
4
Fertility and Surgical Associates of California
Thousand Oaks, California, United States, 91360