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Subcutaneous Progesterone Versus Vaginal Progesterone Gel for Luteal Phase Support in Patients Undergoing In-Vitro Fertilization (IVF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00827983
Recruitment Status : Completed
First Posted : January 23, 2009
Results First Posted : December 26, 2012
Last Update Posted : January 31, 2013
Information provided by (Responsible Party):
IBSA Institut Biochimique SA

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

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 683 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Tolerability of Subcutaneous Progesterone Versus Vaginal Progesterone Gel for Luteal Phase Support in Patients Undergoing In-Vitro Fertilization (IVF)
Study Start Date : January 2009
Actual Primary Completion Date : November 2010
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Progesterone SC Drug: Progesterone
25 mg, s.c., once à day

Active Comparator: Progesterone Vaginal gel Drug: Progesterone
90 mg, vaginally, once à day

Primary Outcome Measures :
  1. Ongoing Pregnancy Rate at the End of the Study [ Time Frame: 10 weeks after treatment start ]

Secondary Outcome Measures :
  1. Delivery Rate and Live Birth Rate [ Time Frame: nearly 9 month after treatment start ]
  2. Implantation Rate [ Time Frame: Four to five weeks after oocytes retrieval ]
    Implantation rate was defined as the mean of the total number of gestational sacs seen divided by the total number of embryos transferred. Values are reported as a percentage.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00827983

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Klinik fur Frauenheilkunde und Geburthilfe - Universistät zu Lübeck
Lübeck, Germany, 23538
First Dept. Obstetric and Gynaecology, Semmelweiss University Faculty of Medicine
Budapest, Hungary, 1088
Unità Ospedaliera di Ginecologia e Ostetricia, Ospedale Civico Brunico
Brunico, Bolzano, Italy, 39031
Clinica Mangiagalli, Università di Milano
Milano, Italy, 20122
Istituto Scientifico Universitario San Raffaele
Milan, Italy, 20132
Azienda Ospedaliero-Sanitaria di Modena
Modena, Italy, 41100
Università degli Studi di Napoli 'Federico II
Naples, Italy, 80131
Ospedale Santa Chiara, Università degli studi di Pisa
Pisa, Italy, 56100
Sorengo, Ticino, Switzerland, 6924
Universitätsfrauenklinik Basel
Basel, Switzerland, 4031
United Kingdom
Midland Fertility Services
Aldridge, West Midlands, United Kingdom, WS9 8LT
St. Bartholomew's Hospital - Center for Reproductive Medicine
London, United Kingdom, EC1A 7BE
Guy's and St. Thomas' Hospital - Women's Health Department
London, United Kingdom, SE1 9RT
The Bridge Center
London, United Kingdom, SE1 9RY
Sponsors and Collaborators
IBSA Institut Biochimique SA
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: IBSA Institut Biochimique SA Identifier: NCT00827983    
Other Study ID Numbers: 07EU/Prg06
First Posted: January 23, 2009    Key Record Dates
Results First Posted: December 26, 2012
Last Update Posted: January 31, 2013
Last Verified: January 2013
Keywords provided by IBSA Institut Biochimique SA:
Luteal Phase Support in IVF patients
Additional relevant MeSH terms:
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Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs