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

• ClinicalTrials.gov Identifier: NCT00828191
• Recruitment Status: Completed
• First Posted: January 23, 2009
• Results First Posted: December 26, 2012
• Last Update Posted: January 31, 2013
• Sponsor: IBSA Institut Biochimique SA
• Information provided by (Responsible Party): IBSA Institut Biochimique SA

Study Description

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.

Condition or disease	Intervention/treatment	Phase
In Vitro Fertilization	Drug: Progesterone	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 800 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Efficacy and Tolerability of Subcutaneous Progesterone (IBSA) Versus Vaginal Progesterone for Luteal Phase Support in Patients Undergoing In Vitro Fertilization (IVF)
• Study Start Date: December 2008
• Actual Primary Completion Date: July 2011
• Actual Study Completion Date: February 2012

Arms and Interventions

Arm	Intervention/treatment
Experimental: Progesterone SC	Drug: Progesterone; 25 mg, once a day, SC
Active Comparator: Progesterone Tablets	Drug: Progesterone; 100 mg, twice a day, vaginally

Outcome Measures

Primary Outcome Measures :

1. Ongoing Pregnancy Rate [ Time Frame: 10 weeks after treatment start ]

Secondary Outcome Measures :

1. Implantation Rate [ Time Frame: 4-5 weeks after treatment start ]
   Implantation rate was defined as the number of gestational sacs divided by the number of embryos transferred (%). This value was calculated for all the patients who had at least one embryo transferred.
2. Delivery Rate [ Time Frame: nearly 9 months after treatment start ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 42 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, California

Reproductive Partners Medical Group, Inc.

Redondo Beach, California, United States, 90277

Fertility Physicians of Northern California

San Jose, California, United States, 95124

Stanford University Medical Center

Stanford, California, United States, 94305

Fertility and Surgical Associates of California

Thousand Oaks, California, United States, 91360

United States, Florida

Center for Reproductive Medicine

Orlando, Florida, United States, 32804

United States, Idaho

Idaho Center for Reproductive Medicine

Boise, Idaho, United States, 83702

United States, Texas

Center for Assisted Reproduction

Bedford, Texas, United States, 76022

United States, Washington

Seattle Reproductive Medicine

Seattle, Washington, United States, 98109

Sponsors and Collaborators

IBSA Institut Biochimique SA

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

• Responsible Party: IBSA Institut Biochimique SA
• ClinicalTrials.gov Identifier: NCT00828191
• Other Study ID Numbers: 07USA/Prg05
• First Posted: January 23, 2009
• Results First Posted: December 26, 2012
• Last Update Posted: January 31, 2013
• Last Verified: January 2013

Keywords provided by IBSA Institut Biochimique SA:

Luteal support in IVF

Additional relevant MeSH terms:

Progesterone; Progestins; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs