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

January 28, 2013 updated by: IBSA Institut Biochimique SA

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

683

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Lübeck, Germany, 23538
        • Klinik fur Frauenheilkunde und Geburthilfe - Universistät zu Lübeck
  • Hungary
      • Budapest, Hungary, 1088
        • First Dept. Obstetric and Gynaecology, Semmelweiss University Faculty of Medicine
  • Italy
      • Milan, Italy, 20132
        • Istituto Scientifico Universitario San Raffaele
      • Milano, Italy, 20122
        • Clinica Mangiagalli, Università di Milano
      • Modena, Italy, 41100
        • Azienda Ospedaliero-Sanitaria di Modena
      • Naples, Italy, 80131
        • Università degli Studi di Napoli 'Federico II
      • Pisa, Italy, 56100
        • Ospedale Santa Chiara, Università degli studi di Pisa
    • Bolzano
      • Brunico, Bolzano, Italy, 39031
        • Unità Ospedaliera di Ginecologia e Ostetricia, Ospedale Civico Brunico
  • Switzerland
      • Basel, Switzerland, 4031
        • Universitätsfrauenklinik Basel
    • Ticino
      • Sorengo, Ticino, Switzerland, 6924
        • IIRM SA
  • United Kingdom
      • London, United Kingdom, EC1A 7BE
        • St. Bartholomew's Hospital - Center for Reproductive Medicine
      • London, United Kingdom, SE1 9RT
        • Guy's and St. Thomas' Hospital - Women's Health Department
      • London, United Kingdom, SE1 9RY
        • The Bridge Center
    • West Midlands
      • Aldridge, West Midlands, United Kingdom, WS9 8LT
        • Midland Fertility Services

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 42 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Progesterone SC
Drug: Progesterone
25 mg, s.c., once à day
Drug: Progesterone
90 mg, vaginally, once à day
ACTIVE_COMPARATOR: Progesterone Vaginal gel
Drug: Progesterone
25 mg, s.c., once à day
Drug: Progesterone
90 mg, vaginally, once à day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Ongoing Pregnancy Rate at the End of the Study
Time Frame: 10 weeks after treatment start
10 weeks after treatment start

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Delivery Rate and Live Birth Rate
Time Frame: nearly 9 month after treatment start
nearly 9 month after treatment start
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.
Four to five weeks after oocytes retrieval

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IBSA Institut Biochimique SA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (ACTUAL)

November 1, 2010

Study Completion (ACTUAL)

May 1, 2011

Study Registration Dates

First Submitted

January 22, 2009

First Submitted That Met QC Criteria

January 22, 2009

First Posted (ESTIMATE)

January 23, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

January 31, 2013

Last Update Submitted That Met QC Criteria

January 28, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07EU/Prg06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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