Clinical trial NCT00828191: Subcutaneous Progesterone Versus Vaginal Progesterone Tablets for Luteal Phase Support in In Vitro Fertilization (IVF)
Official title: Efficacy and Tolerability of Subcutaneous Progesterone (IBSA) Versus Vaginal Progesterone for Luteal Phase Support in Patients Undergoing In Vitro Fertilization (IVF)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: In Vitro Fertilization
Keywords: Luteal support in IVF
Lead sponsor: IBSA Institut Biochimique SA
Sponsor class: INDUSTRY
First posted: 2009-01-23
Enrollment: 800
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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) 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.


Eligibility criteria: 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

Primary outcomes:
measure: Ongoing Pregnancy Rate
timeFrame: 10 weeks after treatment start
Secondary outcomes:
measure: Implantation Rate
timeFrame: 4-5 weeks after treatment start
measure: Delivery Rate
timeFrame: nearly 9 months after treatment start
Other outcomes:
Locations:
city: Redondo Beach
country: United States
facility: Reproductive Partners Medical Group, Inc.
state: California
city: San Jose
country: United States
facility: Fertility Physicians of Northern California
state: California
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Thousand Oaks
country: United States
facility: Fertility and Surgical Associates of California
state: California
city: Orlando
country: United States
facility: Center for Reproductive Medicine
state: Florida
city: Boise
country: United States
facility: Idaho Center for Reproductive Medicine
state: Idaho
city: Bedford
country: United States
facility: Center for Assisted Reproduction
state: Texas
city: Seattle
country: United States
facility: Seattle Reproductive Medicine
state: Washington
Study officials:
References:
citation: Griesinger G, Trevisan S, Cometti B. Endometrial thickness on the day of embryo transfer is a poor predictor of IVF treatment outcome. Hum Reprod Open. 2018 Jan 29;2018(1):hox031. doi: 10.1093/hropen/hox031. eCollection 2018.
citation: Baker VL, Jones CA, Doody K, Foulk R, Yee B, Adamson GD, Cometti B, DeVane G, Hubert G, Trevisan S, Hoehler F, Jones C, Soules M. A randomized, controlled trial comparing the efficacy and safety of aqueous subcutaneous progesterone with vaginal progesterone for luteal phase support of in vitro fertilization. Hum Reprod. 2014 Oct 10;29(10):2212-20. doi: 10.1093/humrep/deu194. Epub 2014 Aug 6.