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

NCT00827983 | Completed Phase 3 Results

• 1 other identifier: 07EU/Prg06
• Study Type: interventional
• Target: 683
• Locations: 5 countries
• Sites: 14

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).

Conditions

In Vitro Fertilization

Keywords

Luteal Phase Support in IVF patients

Outcome Measures

Primary Outcomes (1)

• Ongoing Pregnancy Rate at the End of the Study

  10 weeks after treatment start

Secondary Outcomes (2)

• Delivery Rate and Live Birth Rate

  nearly 9 month after treatment start

• Implantation Rate

  Four to five weeks after oocytes retrieval

Study Arms (2)

Progesterone SC

EXPERIMENTAL

Drug: Progesterone

Progesterone Vaginal gel

ACTIVE COMPARATOR

Drug: Progesterone

Interventions

Progesterone DRUG

25 mg, s.c., once à day

Progesterone SC

Eligibility Criteria

• Age: 18 Years - 42 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• IBSA Institut Biochimique SA: lead

Study Sites (14)

Klinik fur Frauenheilkunde und Geburthilfe - Universistät zu Lübeck

Lübeck, 23538, Germany

Location

First Dept. Obstetric and Gynaecology, Semmelweiss University Faculty of Medicine

Budapest, 1088, Hungary

Location

Unità Ospedaliera di Ginecologia e Ostetricia, Ospedale Civico Brunico

Bruneck, Bolzano, 39031, Italy

Location

Istituto Scientifico Universitario San Raffaele

Milan, Milan, 20132, Italy

Location

Università degli Studi di Napoli 'Federico II

Naples, Naples, 80131, Italy

Location

Clinica Mangiagalli, Università di Milano

Milan, 20122, Italy

Location

Azienda Ospedaliero-Sanitaria di Modena

Modena, 41100, Italy

Location

Ospedale Santa Chiara, Università degli studi di Pisa

Pisa, 56100, Italy

Location

IIRM SA

Sorengo, Canton Ticino, 6924, Switzerland

Location

Universitätsfrauenklinik Basel

Basel, 4031, Switzerland

Location

Midland Fertility Services

Aldridge, West Midlands, WS9 8LT, United Kingdom

Location

St. Bartholomew's Hospital - Center for Reproductive Medicine

London, EC1A 7BE, United Kingdom

Location

Guy's and St. Thomas' Hospital - Women's Health Department

London, SE1 9RT, United Kingdom

Location

The Bridge Center

London, SE1 9RY, United Kingdom

Location

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: 30895243 DERIVED

• Lockwood G, Griesinger G, Cometti B; 13 European Centers. Subcutaneous progesterone versus vaginal progesterone gel for luteal phase support in in vitro fertilization: a noninferiority randomized controlled study. Fertil Steril. 2014 Jan;101(1):112-119.e3. doi: 10.1016/j.fertnstert.2013.09.010. Epub 2013 Oct 17.

  PMID: 24140033 DERIVED

MeSH Terms

Interventions

Progesterone

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corpus Luteum Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones

Limitations and Caveats

no special limitations of the trial were detected.

Results Point of Contact

• Title: Clinical trial manager
• Organization: IBSA Institut biochimique

barbara.cometti@ibsa.ch

+41583601000

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: January 1, 2009
• Primary Completion: November 1, 2010
• Study Completion: May 1, 2011
• Last Updated: January 31, 2013
• Results First Posted: December 26, 2012

Record last verified: 2013-01

Locations

DE (1); CH (2); HU (1); GB (4); IT (6)