Clinical trial NCT00827983: Subcutaneous Progesterone Versus Vaginal Progesterone Gel for Luteal Phase Support in Patients Undergoing In-Vitro Fertilization (IVF)
Official title: Efficacy and Tolerability of Subcutaneous Progesterone Versus Vaginal Progesterone Gel for Luteal Phase Support in Patients Undergoing In-Vitro Fertilization (IVF)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: In Vitro Fertilization
Keywords: Luteal Phase Support in IVF patients
Lead sponsor: IBSA Institut Biochimique SA
Sponsor class: INDUSTRY
First posted: 2009-01-23
Enrollment: 683
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: Ongoing Pregnancy Rate at the End of the Study
timeFrame: 10 weeks after treatment start
Secondary outcomes:
measure: Delivery Rate and Live Birth Rate
timeFrame: nearly 9 month after treatment start
measure: Implantation Rate
timeFrame: Four to five weeks after oocytes retrieval
Other outcomes:
Locations:
city: Lübeck
country: Germany
facility: Klinik fur Frauenheilkunde und Geburthilfe - Universistät zu Lübeck
city: Budapest
country: Hungary
facility: First Dept. Obstetric and Gynaecology, Semmelweiss University Faculty of Medicine
city: Brunico
country: Italy
facility: Unità Ospedaliera di Ginecologia e Ostetricia, Ospedale Civico Brunico
state: Bolzano
city: Milano
country: Italy
facility: Clinica Mangiagalli, Università di Milano
city: Milan
country: Italy
facility: Istituto Scientifico Universitario San Raffaele
city: Modena
country: Italy
facility: Azienda Ospedaliero-Sanitaria di Modena
city: Naples
country: Italy
facility: Università degli Studi di Napoli 'Federico II
city: Pisa
country: Italy
facility: Ospedale Santa Chiara, Università degli studi di Pisa
city: Sorengo
country: Switzerland
facility: IIRM SA
state: Ticino
city: Basel
country: Switzerland
facility: Universitätsfrauenklinik Basel
city: Aldridge
country: United Kingdom
facility: Midland Fertility Services
state: West Midlands
city: London
country: United Kingdom
facility: St. Bartholomew's Hospital - Center for Reproductive Medicine
city: London
country: United Kingdom
facility: Guy's and St. Thomas' Hospital - Women's Health Department
city: London
country: United Kingdom
facility: The Bridge Center
Study officials:
References:
citation: 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.
citation: 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.