Subcutaneous Progesterone Versus Vaginal Progesterone Tablets for Luteal Phase Support in In Vitro Fertilization (IVF)
Efficacy and Tolerability of Subcutaneous Progesterone (IBSA) Versus Vaginal Progesterone for Luteal Phase Support in Patients Undergoing In Vitro Fertilization (IVF)
1 other identifier
interventional
800
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2008
Typical duration for phase_3
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
January 22, 2009
CompletedFirst Posted
Study publicly available on registry
January 23, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2012
CompletedResults Posted
Study results publicly available
December 26, 2012
CompletedJanuary 31, 2013
January 1, 2013
2.6 years
January 22, 2009
November 26, 2012
January 28, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Ongoing Pregnancy Rate
10 weeks after treatment start
Secondary Outcomes (2)
Implantation Rate
4-5 weeks after treatment start
Delivery Rate
nearly 9 months after treatment start
Study Arms (2)
Progesterone SC
EXPERIMENTALProgesterone Tablets
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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);
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Reproductive Partners Medical Group, Inc.
Redondo Beach, California, 90277, United States
Fertility Physicians of Northern California
San Jose, California, 95124, United States
Stanford University Medical Center
Stanford, California, 94305, United States
Fertility and Surgical Associates of California
Thousand Oaks, California, 91360, United States
Center for Reproductive Medicine
Orlando, Florida, 32804, United States
Idaho Center for Reproductive Medicine
Boise, Idaho, 83702, United States
Center for Assisted Reproduction
Bedford, Texas, 76022, United States
Seattle Reproductive Medicine
Seattle, Washington, 98109, United States
Related Publications (2)
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.
PMID: 30895243DERIVEDBaker 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.
PMID: 25100106DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Limitations and Caveats
No limitations of the trial reported.
Results Point of Contact
- Title
- IBSA U.S. Agent
- Organization
- IBSA Institut Biochimique SA
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 22, 2009
First Posted
January 23, 2009
Study Start
December 1, 2008
Primary Completion
July 1, 2011
Study Completion
February 1, 2012
Last Updated
January 31, 2013
Results First Posted
December 26, 2012
Record last verified: 2013-01