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

NCT ID: NCT00827983

Last Updated: 2013-01-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 683 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2011-05-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Progesterone SC

Group Type: EXPERIMENTAL

Progesterone

Intervention Type: DRUG

25 mg, s.c., once à day

Progesterone Vaginal gel

Group Type: ACTIVE_COMPARATOR

Progesterone

Intervention Type: DRUG

90 mg, vaginally, once à day

Interventions

Progesterone

25 mg, s.c., once à day

Intervention Type: DRUG

Progesterone

90 mg, vaginally, once à day

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 42 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

IBSA Institut Biochimique SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Klinik fur Frauenheilkunde und Geburthilfe - Universistät zu Lübeck

Lübeck, , Germany

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

Budapest, , Hungary

Unità Ospedaliera di Ginecologia e Ostetricia, Ospedale Civico Brunico

Bruneck, Bolzano, Italy

Istituto Scientifico Universitario San Raffaele

Milan, Milan, Italy

Università degli Studi di Napoli 'Federico II

Naples, Naples, Italy

Clinica Mangiagalli, Università di Milano

Milan, , Italy

Azienda Ospedaliero-Sanitaria di Modena

Modena, , Italy

Ospedale Santa Chiara, Università degli studi di Pisa

Pisa, , Italy

IIRM SA

Sorengo, Canton Ticino, Switzerland

Universitätsfrauenklinik Basel

Basel, , Switzerland

Midland Fertility Services

Aldridge, West Midlands, United Kingdom

St. Bartholomew's Hospital - Center for Reproductive Medicine

London, , United Kingdom

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

London, , United Kingdom

The Bridge Center

London, , United Kingdom

Countries

Germany; Hungary; Italy; Switzerland; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 30895243 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 24140033 (View on PubMed)

Other Identifiers

07EU/Prg06

Identifier Type: -

Identifier Source: org_study_id